Purpose

This randomized phase III trial studies combination chemotherapy with blinatumomab to see how well it works compared to induction chemotherapy alone in treating patients with newly diagnosed breakpoint cluster region (BCR)-c-abl oncogene 1, non-receptor tyrosine kinase (ABL)-negative B lineage acute lymphoblastic leukemia. Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Immunotherapy with monoclonal antibodies, such as blinatumomab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread It is not yet known whether combination chemotherapy is more effective with or without blinatumomab in treating newly diagnosed acute lymphoblastic leukemia.

Conditions

Eligibility

Eligible Ages
Between 30 Years and 70 Years
Eligible Genders
All
Accepts Healthy Volunteers
Yes

Criteria


Inclusion Criteria:

- PRE-REGISTRATION

- Diagnostic bone marrow and peripheral blood specimens must be submitted for
immunophenotyping and selected molecular testing, and the establishment of BCR/ABL
status; testing will be performed by the Eastern Cooperative Oncology Group
(ECOG)-American College of Radiation Imaging Network (ACRIN) Leukemia Translational
Research Laboratory (LTRL) and reported to the institution

- NOTE: IT IS ESSENTIAL THAT A SAMPLE CONTAINING SUFFICIENT BLAST CELLS BE
SUBMITTED TO THE ECOG-ACRIN LTRL AT BASELINE SO THAT SUBSEQUENT BONE MARROW
ASSESSMENTS OF MRD CAN BE DONE; IN ADDITION TO ALLOWING THE LTRL TO CONFIRM
ELIGIBILITY BASED ON BLAST CELL IMMUNOPHENOTYPE AND BCR/ABL STATUS, IT IS ALSO
IMPERATIVE THAT AN ADEQUATE NUMBER OF BLASTS BE BANKED FOR ANALYSIS BY DRS
MULLIGHAN/WILLMAN. WITHOUT ADEQUATE BASELINE SAMPLES, PATIENTS WILL NOT BE ABLE
TO BE TREATED AND RANDOMIZED ON THIS PROTOCOL; IF A BONE MARROW ASPIRATE IS NOT
AVAILABLE FOR LTRL SUBMISSION AT BASELINE, IT IS IMPERATIVE THAT DR PAIETTA FROM
THE LTRL IS CALLED TO DISCUSS THE PERIPHERAL BLOOD WBC AND BLAST COUNT BEFORE
BLOOD ONLY IS SUBMITTED

- NOTE: Hydroxyurea can be given for up to 5 days prior to initiation of protocol
therapy for control of leukocyte count and/or other symptoms or signs;
corticosteroids can be given after pre-registration to the protocol and
submission of baseline marrow and blood samples for control of leukocyte count
and/or other symptoms or signs prior to initiation of protocol therapy if needed;
if corticosteroids are given prior to pre-registration, contact the study chair
as the patient may still be eligible to participate

- INDUCTION ELIGIBILITY CRITERIA-STEP 1

- New diagnosis of B lineage ALL must be made upon bone marrow or peripheral blood
immunophenotyping; cases with myeloid antigen expression, but unequivocal lymphoid
immunophenotype, are eligible

- Mature B ALL (Burkitt's-like leukemia) is excluded from enrollment in this trial;
pre-study bone marrow biopsy and aspirate must be completed =< 1 week prior to
registration

- Negativity for the Philadelphia chromosome must be established by conventional
cytogenetics, fluorescence in situ hybridization (FISH) and/or polymerase chain
reaction (PCR); patients who are negative for the Philadelphia chromosome by
conventional cytogenetics must have FISH or PCR performed for BCR/ABL to exclude
occult translocations

- Cytogenetic analysis must be performed from diagnostic bone marrow (preferred) or if
adequate number of circulating blasts from peripheral blood; FISH testing for common
B-lineage ALL abnormalities including t(9;22) (BCR/ABL1), t(12;21) (ETS-variant gene 6
[ETV6]/runt-related transcription factor 1 [RUNX1]), t(1;19) (pre-B-cell leukemia
homeobox 1 [PBX1]/transcription factor 3 [TCF3]), +4,+10,+17, (centromeric
[Cen]4/Cen10/Cen17), t(11q23;var), (myeloid/lymphoid or mixed lineage leukemia [MLL]),
deletion (del)(9p) (cyclin-dependent kinase inhibitor 2A [CDKN2A]/Cen9), and t(14;var)
(immunoglobulin heavy chain [IGH] is encouraged); if there are few or no circulating
blasts and an adequate marrow sample cannot be obtained for cytogenetic analysis, the
patient may still enroll on the trial

- Patient must not have a concurrent active malignancy for which they are receiving
treatment

- Serum direct bilirubin < 2 mg/dl or serum total bilirubin =< 3 (obtained =< 48 hours
prior to registration); NOTE: the above stipulation for normal hepatic function does
not apply if liver dysfunction is due to leukemia infiltration

- Serum creatinine < 2 mg/dl (obtained =< 48 hours prior to registration); NOTE: the
above stipulation for normal hepatic function does not apply if liver dysfunction is
due to leukemia infiltration

- Patient should be human leukocyte antigen (HLA) typed (A, B, C, DR and DQ) during
induction therapy phase or a written explanation for not undergoing HLA typing on the
flow sheet

- Patient must not have intercurrent organ damage or medical problems that will
jeopardize the outcome of therapy (i.e., psychiatric disorder, drug abuse, pregnancy)

- Patients with known human immunodeficiency virus (HIV) infection are eligible if they
meet all of the following criteria:

- No history of acquired immune deficiency syndrome (AIDS)-related complications
other than a history of low CD4+ T-cell count (< 200/mm^3) prior to initiation of
combination antiretroviral therapy; on study CD4+ T-cell count may not be
informative due to leukemia and should not be used as an exclusion criterion if
low

- Patient must be healthy on the basis of HIV disease with high likelihood of near
normal life span were it not for the leukemia

- Patient must have serum HIV viral load of < 200 copies/mm^3

- Patient must be on combination antiretroviral therapy with minimal
pharmacokinetic interactions with study therapy and minimal overlapping clinical
toxicity with protocol therapy

- Patient must not be receiving protease inhibitors or once daily formulations
containing cobicistat, stavudine, or on regimens containing stavudine or
zidovudine

- It is recommended to utilize a regimen of the integrase inhibitor, dolutegravir,
combined with either disoproxil fumarate/emtricitabine or dolutegravir combined
with tenofovir alafenamide/emtricitabine

- Patient must not have an antecedent hematologic disorder

- Patient must have no history of recent myocardial infarction (within three months),
uncontrolled congestive heart failure, or uncontrolled cardiac arrhythmia

- Patient must not have a history or presence of clinically relevant central nervous
system (CNS) pathology such as epilepsy, seizure, paresis, aphasia, stroke, severe
brain injuries, dementia; Parkinson's disease, cerebellar disease, organic brain
syndrome, psychosis, or other significant CNS abnormalities

- Patient must have a normal cardiac ejection fraction by pretreatment multigated
acquisition scan (MUGA) or echocardiogram within 4 weeks prior to registration
(resting ejection fraction >= 40% or >= 5% increase with exercise), shortening
fraction by echocardiogram >= 24%, or to within the normal range of values for the
institution

- Patient must not have an active uncontrolled infection

- Women must not be pregnant or breast-feeding and must not become pregnant or
breastfeed during protocol therapy and for at least 3 months after protocol therapy;
woman of childbearing potential must abstain from sexual activity or be willing to use
2 highly effective forms of contraception throughout protocol therapy and for at least
an additional 3 months after the last dose of protocol-specified therapy; all females
of childbearing potential must have a blood test or urine study within 2 weeks prior
to registration to rule out pregnancy; a female of childbearing potential is any
woman, regardless of sexual orientation or whether they have undergone tubal ligation,
who meets the following criteria: has not undergone a hysterectomy or bilateral
oophorectomy; or has not been naturally postmenopausal for at least 24 consecutive
months (i.e., has had menses at any time in the preceding 24 consecutive months)

- Men who have a female partner of childbearing potential must be willing to use 2
highly effective forms of contraception throughout protocol therapy and for at least
an additional 3 months after the last dose of protocol-specified therapy; men who have
a pregnant partner must be willing to use a condom during sexual activity throughout
protocol therapy and for 3 months after the last dose of protocol-specified therapy

- ECOG performance score 0-3

- Patient must have given written informed consent

- POST-INDUCTION THERAPY ELIGIBILITY CRITERIA (PRIOR TO INTENSIFICATION-STEP 2)

- ECOG performance status 0-2

- Patients must have achieved a CR or CRi

- Patients who have achieved a CR or CRi must have maintained peripheral blood evidence
of a CR or CRi

- Patient must be CNS (cerebrospinal fluid [CSF]) negative for leukemia

- Patients must have resolved any serious infectious complications related to induction

- Any significant medical complications related to induction must have resolved

- Serum creatinine =< 2.0 mg/dl (obtained =< 48 hours prior to registration)

- Serum direct bilirubin < 2 mg/dL or serum total bilirubin =< 3 (obtained =< 48 hours
prior to registration)

- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) < 3 x upper limit
of normal (ULN) (obtained =< 48 hours prior to registration)

- RANDOMIZATION TO BLINATUMOMAB OR NO BLINATUMOMAB-STEP 3

- Patients must have an ECOG performance status of 0-2

- Patients must have maintained peripheral blood evidence of a remission and must have a
CR or CRi, confirmed on restaging bone marrow (BM) aspirate and biopsy

- Patients must have resolved any serious infectious complications related to therapy

- Any significant medical complications related to therapy must have resolved

- Direct or total bilirubin < 1.5 x ULN (unless related to Gilbert's or Meulengracht's
syndrome); the values must be obtained within 48 hours prior to randomization

- Serum creatinine < 1.5 x ULN; the values must be obtained within 48 hours prior to
randomization

- Bone marrow aspirates must be submitted for centralized minimal residual disease (MRD)
assessment performed by the ECOG-ACRIN Leukemia Translational Research Laboratory

- MRD results will be reported to the submitting institution

- NOTE: FOR MRD ASSESSMENTS, AN ASPIRATE FROM A SEPARATE BONE MARROW ASPIRATION
SITE MUST BE SUBMITTED (THE NEEDLE CAN BE RE-DIRECTED THROUGH THE SAME SKIN
PUNCTURE SITE); ONLY SUBMIT ASPIRATES FROM THE FIRST PULL OF AN ASPIRATION SITE
FOR MRD TESTING; DO NOT SUBMIT SAMPLES FROM THE SECOND OR THIRD PULL OF THE SAME
ASPIRATION SITE

- In B-lineage ALL, MRD levels in peripheral blood or from a dilute marrow
aspiration can be 300% lower, on average, than those in bone marrow at a given
time point; submitting a first pull from a separate aspiration site will ensure
that MRD determinations used in randomization and trial interpretation are
accurate

- NOTE: failure to submit bone marrow aspirates will result in a major
violation at the time of an audit

- CRITERIA FOR ALLOGENEIC TRANSPLANTATION

- A suitable donor must be identified; there are no restrictions on donor type and can
include a matched sibling, a matched or mismatched unrelated donor, a family haplotype
matched donor or a cord blood donor (single or double)

- Patients should meet the eligibility criteria for RANDOMIZATION TO BLINATUMOMAB OR NO
BLINATUMOMAB-STEP 3

- Patients must be considered reliable enough to comply with the medication regimen and
follow-up, and have social support necessary to allow this compliance

- CRITERIA FOR MAINTENANCE THERAPY-STEP 4: Patients must have an ECOG performance status
of 0-3

- CRITERIA FOR MAINTENANCE THERAPY-STEP 4: Patients must have maintained peripheral
blood evidence of a remission and must have a CR or CRi, confirmed on restaging BM
aspirate and biopsy

- CRITERIA FOR MAINTENANCE THERAPY-STEP 4: Patients must have resolved any serious
infectious complications related to therapy

- CRITERIA FOR MAINTENANCE THERAPY-STEP 4: Any significant medical complications related
to therapy must have resolved

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Arm I (blinatumomab, chemotherapy)
See Detailed Description
  • Procedure: Allogeneic Hematopoietic Stem Cell Transplantation
    Undergo allogeneic hematopoietic SCT
    Other names:
    • Allogeneic Hematopoietic Cell Transplantation
    • Allogeneic Stem Cell Transplantation
    • HSC
    • HSCT
  • Biological: Blinatumomab
    Given IV
    Other names:
    • Anti-CD19 x Anti-CD3 Bispecific Monoclonal Antibody
    • Anti-CD19/Anti-CD3 Recombinant Bispecific Monoclonal Antibody MT103
    • Blincyto
    • MEDI-538
    • MT-103
  • Drug: Cyclophosphamide
    Given PO or IV
    Other names:
    • (-)-Cyclophosphamide
    • 2H-1,3,2-Oxazaphosphorine, 2-[bis(2-chloroethyl)amino]tetrahydro-, 2-oxide, monohydrate
    • Carloxan
    • Ciclofosfamida
    • Ciclofosfamide
    • Cicloxal
    • Clafen
    • Claphene
    • CP monohydrate
    • CTX
    • CYCLO-cell
    • Cycloblastin
    • Cycloblastine
    • Cyclophospham
    • Cyclophosphamid monohydrate
    • Cyclophosphamide Monohydrate
    • Cyclophosphamidum
    • Cyclophosphan
    • Cyclophosphane
    • Cyclophosphanum
    • Cyclostin
    • Cyclostine
    • Cytophosphan
    • Cytophosphane
    • Cytoxan
    • Fosfaseron
    • Genoxal
    • Genuxal
    • Ledoxina
    • Mitoxan
    • Neosar
    • Revimmune
    • Syklofosfamid
    • WR- 138719
  • Drug: Cytarabine
    Given IT, IV, or SC
    Other names:
    • .beta.-Cytosine arabinoside
    • 1-.beta.-D-Arabinofuranosyl-4-amino-2(1H)pyrimidinone
    • 1-.beta.-D-Arabinofuranosylcytosine
    • 1-Beta-D-arabinofuranosyl-4-amino-2(1H)pyrimidinone
    • 1-Beta-D-arabinofuranosylcytosine
    • 1.beta.-D-Arabinofuranosylcytosine
    • 2(1H)-Pyrimidinone, 4-Amino-1-beta-D-arabinofuranosyl-
    • 2(1H)-Pyrimidinone, 4-amino-1.beta.-D-arabinofuranosyl-
    • Alexan
    • Ara-C
    • ARA-cell
    • Arabine
    • Arabinofuranosylcytosine
    • Arabinosylcytosine
    • Aracytidine
    • Aracytin
    • Aracytine
    • Beta-cytosine Arabinoside
    • CHX-3311
    • Cytarabinum
    • Cytarbel
    • Cytosar
    • Cytosine Arabinoside
    • Cytosine-.beta.-arabinoside
    • Cytosine-beta-arabinoside
    • Erpalfa
    • Starasid
    • Tarabine PFS
    • U 19920
    • U-19920
    • Udicil
    • WR-28453
  • Drug: Daunorubicin Hydrochloride
    Given IV
    Other names:
    • Cerubidin
    • Cerubidine
    • Cloridrato de Daunorubicina
    • Daunoblastin
    • Daunoblastina
    • Daunoblastine
    • Daunomycin Hydrochloride
    • Daunomycin, hydrochloride
    • Daunorubicin.HCl
    • Daunorubicini Hydrochloridum
    • FI-6339
    • Ondena
    • RP-13057
    • Rubidomycin Hydrochloride
    • Rubilem
  • Drug: Dexamethasone
    Given PO
    Other names:
    • Aacidexam
    • Adexone
    • Aknichthol Dexa
    • Alba-Dex
    • Alin
    • Alin Depot
    • Alin Oftalmico
    • Amplidermis
    • Anemul mono
    • Auricularum
    • Auxiloson
    • Baycadron
    • Baycuten
    • Baycuten N
    • Cortidexason
    • Cortisumman
    • Decacort
    • Decadrol
    • Decadron
    • Decadron DP
    • Decalix
    • Decameth
    • Decasone R.p.
    • Dectancyl
    • Dekacort
    • Deltafluorene
    • Deronil
    • Desamethasone
    • Desameton
    • Dexa-Mamallet
    • Dexa-Rhinosan
    • Dexa-Scheroson
    • Dexa-sine
    • Dexacortal
    • Dexacortin
    • Dexafarma
    • Dexafluorene
    • Dexalocal
    • Dexamecortin
    • Dexameth
    • Dexamethasone Intensol
    • Dexamethasonum
    • Dexamonozon
    • Dexapos
    • Dexinoral
    • Dexone
    • Dinormon
    • Fluorodelta
    • Fortecortin
    • Gammacorten
    • Hexadecadrol
    • Hexadrol
    • Lokalison-F
    • Loverine
    • Methylfluorprednisolone
    • Millicorten
    • Mymethasone
    • Orgadrone
    • Spersadex
    • TaperDex
    • Visumetazone
    • ZoDex
  • Drug: Etoposide
    Given IV
    Other names:
    • Demethyl Epipodophyllotoxin Ethylidine Glucoside
    • EPEG
    • Lastet
    • Toposar
    • Vepesid
    • VP 16
    • VP 16-213
    • VP-16
    • VP-16-213
    • VP16
  • Other: Laboratory Biomarker Analysis
    Correlative studies
  • Drug: Mercaptopurine
    Given PO
    Other names:
    • 3H-Purine-6-thiol
    • 6 MP
    • 6 Thiohypoxanthine
    • 6 Thiopurine
    • 6-Mercaptopurine
    • 6-Mercaptopurine Monohydrate
    • 6-MP
    • 6-Purinethiol
    • 6-Thiopurine
    • 6-Thioxopurine
    • 6H-Purine-6-thione, 1,7-dihydro- (9CI)
    • 7-Mercapto-1,3,4,6-tetrazaindene
    • Alti-Mercaptopurine
    • Azathiopurine
    • BW 57-323H
    • Flocofil
    • Ismipur
    • Leukerin
    • Leupurin
    • Mercaleukim
    • Mercaleukin
    • Mercaptina
    • Mercaptopurinum
    • Mercapurin
    • Mern
    • NCI-C04886
    • Puri-Nethol
    • Purimethol
    • Purine, 6-mercapto-
    • Purine-6-thiol (8CI)
    • Purine-6-thiol, monohydrate
    • Purinethiol
    • Purinethol
    • U-4748
    • WR-2785
  • Drug: Methotrexate
    Given PO, IT or IV
    Other names:
    • Abitrexate
    • Alpha-Methopterin
    • Amethopterin
    • Brimexate
    • CL 14377
    • CL-14377
    • Emtexate
    • Emthexat
    • Emthexate
    • Farmitrexat
    • Fauldexato
    • Folex
    • Folex PFS
    • Lantarel
    • Ledertrexate
    • Lumexon
    • Maxtrex
    • Medsatrexate
    • Metex
    • Methoblastin
    • Methotrexate LPF
    • Methotrexate Methylaminopterin
    • Methotrexatum
    • Metotrexato
    • Metrotex
    • Mexate
    • Mexate-AQ
    • MTX
    • Novatrex
    • Rheumatrex
    • Texate
    • Tremetex
    • Trexeron
    • Trixilem
    • WR-19039
  • Drug: Pegaspargase
    Given IM or IV
    Other names:
    • L-Asparaginase with Polyethylene Glycol
    • Oncaspar
    • Oncaspar-IV
    • PEG-Asparaginase
    • PEG-L-Asparaginase
    • PEG-L-Asparaginase (Enzon - Kyowa Hakko)
    • PEGLA
    • Polyethylene Glycol L-Asparaginase
    • Polyethylene Glycol-L-Asparaginase
  • Drug: Prednisone
    Given PO
    Other names:
    • .delta.1-Cortisone
    • 1, 2-Dehydrocortisone
    • Adasone
    • Cortancyl
    • Dacortin
    • DeCortin
    • Decortisyl
    • Decorton
    • Delta 1-Cortisone
    • Delta-Dome
    • Deltacortene
    • Deltacortisone
    • Deltadehydrocortisone
    • Deltasone
    • Deltison
    • Deltra
    • Econosone
    • Lisacort
    • Meprosona-F
    • Metacortandracin
    • Meticorten
    • Ofisolona
    • Orasone
    • Panafcort
    • Panasol-S
    • Paracort
    • Perrigo Prednisone
    • PRED
    • Predicor
    • Predicorten
    • Prednicen-M
    • Prednicort
    • Prednidib
    • Prednilonga
    • Predniment
    • Prednisone Intensol
    • Prednisonum
    • Prednitone
    • Promifen
    • Rayos
    • Servisone
    • SK-Prednisone
  • Biological: Rituximab
    Given IV
    Other names:
    • ABP 798
    • BI 695500
    • C2B8 Monoclonal Antibody
    • Chimeric Anti-CD20 Antibody
    • CT-P10
    • IDEC-102
    • IDEC-C2B8
    • IDEC-C2B8 Monoclonal Antibody
    • MabThera
    • Monoclonal Antibody IDEC-C2B8
    • PF-05280586
    • Rituxan
    • Rituximab ABBS
    • Rituximab Biosimilar ABP 798
    • Rituximab Biosimilar BI 695500
    • Rituximab Biosimilar CT-P10
    • Rituximab Biosimilar GB241
    • Rituximab Biosimilar IBI301
    • Rituximab Biosimilar JHL1101
    • Rituximab Biosimilar PF-05280586
    • Rituximab Biosimilar RTXM83
    • Rituximab Biosimilar SAIT101
    • rituximab biosimilar TQB2303
    • rituximab-abbs
    • RTXM83
    • Truxima
  • Drug: Vincristine Sulfate
    Given IV
    Other names:
    • Kyocristine
    • Leurocristine sulfate
    • Leurocristine, sulfate
    • Oncovin
    • Vincasar
    • Vincosid
    • Vincrex
    • Vincristine, sulfate
Active Comparator
Arm II (chemotherapy)
See Detailed Description
  • Procedure: Allogeneic Hematopoietic Stem Cell Transplantation
    Undergo allogeneic hematopoietic SCT
    Other names:
    • Allogeneic Hematopoietic Cell Transplantation
    • Allogeneic Stem Cell Transplantation
    • HSC
    • HSCT
  • Drug: Cyclophosphamide
    Given PO or IV
    Other names:
    • (-)-Cyclophosphamide
    • 2H-1,3,2-Oxazaphosphorine, 2-[bis(2-chloroethyl)amino]tetrahydro-, 2-oxide, monohydrate
    • Carloxan
    • Ciclofosfamida
    • Ciclofosfamide
    • Cicloxal
    • Clafen
    • Claphene
    • CP monohydrate
    • CTX
    • CYCLO-cell
    • Cycloblastin
    • Cycloblastine
    • Cyclophospham
    • Cyclophosphamid monohydrate
    • Cyclophosphamide Monohydrate
    • Cyclophosphamidum
    • Cyclophosphan
    • Cyclophosphane
    • Cyclophosphanum
    • Cyclostin
    • Cyclostine
    • Cytophosphan
    • Cytophosphane
    • Cytoxan
    • Fosfaseron
    • Genoxal
    • Genuxal
    • Ledoxina
    • Mitoxan
    • Neosar
    • Revimmune
    • Syklofosfamid
    • WR- 138719
  • Drug: Cytarabine
    Given IT, IV, or SC
    Other names:
    • .beta.-Cytosine arabinoside
    • 1-.beta.-D-Arabinofuranosyl-4-amino-2(1H)pyrimidinone
    • 1-.beta.-D-Arabinofuranosylcytosine
    • 1-Beta-D-arabinofuranosyl-4-amino-2(1H)pyrimidinone
    • 1-Beta-D-arabinofuranosylcytosine
    • 1.beta.-D-Arabinofuranosylcytosine
    • 2(1H)-Pyrimidinone, 4-Amino-1-beta-D-arabinofuranosyl-
    • 2(1H)-Pyrimidinone, 4-amino-1.beta.-D-arabinofuranosyl-
    • Alexan
    • Ara-C
    • ARA-cell
    • Arabine
    • Arabinofuranosylcytosine
    • Arabinosylcytosine
    • Aracytidine
    • Aracytin
    • Aracytine
    • Beta-cytosine Arabinoside
    • CHX-3311
    • Cytarabinum
    • Cytarbel
    • Cytosar
    • Cytosine Arabinoside
    • Cytosine-.beta.-arabinoside
    • Cytosine-beta-arabinoside
    • Erpalfa
    • Starasid
    • Tarabine PFS
    • U 19920
    • U-19920
    • Udicil
    • WR-28453
  • Drug: Daunorubicin Hydrochloride
    Given IV
    Other names:
    • Cerubidin
    • Cerubidine
    • Cloridrato de Daunorubicina
    • Daunoblastin
    • Daunoblastina
    • Daunoblastine
    • Daunomycin Hydrochloride
    • Daunomycin, hydrochloride
    • Daunorubicin.HCl
    • Daunorubicini Hydrochloridum
    • FI-6339
    • Ondena
    • RP-13057
    • Rubidomycin Hydrochloride
    • Rubilem
  • Drug: Dexamethasone
    Given PO
    Other names:
    • Aacidexam
    • Adexone
    • Aknichthol Dexa
    • Alba-Dex
    • Alin
    • Alin Depot
    • Alin Oftalmico
    • Amplidermis
    • Anemul mono
    • Auricularum
    • Auxiloson
    • Baycadron
    • Baycuten
    • Baycuten N
    • Cortidexason
    • Cortisumman
    • Decacort
    • Decadrol
    • Decadron
    • Decadron DP
    • Decalix
    • Decameth
    • Decasone R.p.
    • Dectancyl
    • Dekacort
    • Deltafluorene
    • Deronil
    • Desamethasone
    • Desameton
    • Dexa-Mamallet
    • Dexa-Rhinosan
    • Dexa-Scheroson
    • Dexa-sine
    • Dexacortal
    • Dexacortin
    • Dexafarma
    • Dexafluorene
    • Dexalocal
    • Dexamecortin
    • Dexameth
    • Dexamethasone Intensol
    • Dexamethasonum
    • Dexamonozon
    • Dexapos
    • Dexinoral
    • Dexone
    • Dinormon
    • Fluorodelta
    • Fortecortin
    • Gammacorten
    • Hexadecadrol
    • Hexadrol
    • Lokalison-F
    • Loverine
    • Methylfluorprednisolone
    • Millicorten
    • Mymethasone
    • Orgadrone
    • Spersadex
    • TaperDex
    • Visumetazone
    • ZoDex
  • Drug: Etoposide
    Given IV
    Other names:
    • Demethyl Epipodophyllotoxin Ethylidine Glucoside
    • EPEG
    • Lastet
    • Toposar
    • Vepesid
    • VP 16
    • VP 16-213
    • VP-16
    • VP-16-213
    • VP16
  • Other: Laboratory Biomarker Analysis
    Correlative studies
  • Drug: Mercaptopurine
    Given PO
    Other names:
    • 3H-Purine-6-thiol
    • 6 MP
    • 6 Thiohypoxanthine
    • 6 Thiopurine
    • 6-Mercaptopurine
    • 6-Mercaptopurine Monohydrate
    • 6-MP
    • 6-Purinethiol
    • 6-Thiopurine
    • 6-Thioxopurine
    • 6H-Purine-6-thione, 1,7-dihydro- (9CI)
    • 7-Mercapto-1,3,4,6-tetrazaindene
    • Alti-Mercaptopurine
    • Azathiopurine
    • BW 57-323H
    • Flocofil
    • Ismipur
    • Leukerin
    • Leupurin
    • Mercaleukim
    • Mercaleukin
    • Mercaptina
    • Mercaptopurinum
    • Mercapurin
    • Mern
    • NCI-C04886
    • Puri-Nethol
    • Purimethol
    • Purine, 6-mercapto-
    • Purine-6-thiol (8CI)
    • Purine-6-thiol, monohydrate
    • Purinethiol
    • Purinethol
    • U-4748
    • WR-2785
  • Drug: Methotrexate
    Given PO, IT or IV
    Other names:
    • Abitrexate
    • Alpha-Methopterin
    • Amethopterin
    • Brimexate
    • CL 14377
    • CL-14377
    • Emtexate
    • Emthexat
    • Emthexate
    • Farmitrexat
    • Fauldexato
    • Folex
    • Folex PFS
    • Lantarel
    • Ledertrexate
    • Lumexon
    • Maxtrex
    • Medsatrexate
    • Metex
    • Methoblastin
    • Methotrexate LPF
    • Methotrexate Methylaminopterin
    • Methotrexatum
    • Metotrexato
    • Metrotex
    • Mexate
    • Mexate-AQ
    • MTX
    • Novatrex
    • Rheumatrex
    • Texate
    • Tremetex
    • Trexeron
    • Trixilem
    • WR-19039
  • Drug: Pegaspargase
    Given IM or IV
    Other names:
    • L-Asparaginase with Polyethylene Glycol
    • Oncaspar
    • Oncaspar-IV
    • PEG-Asparaginase
    • PEG-L-Asparaginase
    • PEG-L-Asparaginase (Enzon - Kyowa Hakko)
    • PEGLA
    • Polyethylene Glycol L-Asparaginase
    • Polyethylene Glycol-L-Asparaginase
  • Drug: Prednisone
    Given PO
    Other names:
    • .delta.1-Cortisone
    • 1, 2-Dehydrocortisone
    • Adasone
    • Cortancyl
    • Dacortin
    • DeCortin
    • Decortisyl
    • Decorton
    • Delta 1-Cortisone
    • Delta-Dome
    • Deltacortene
    • Deltacortisone
    • Deltadehydrocortisone
    • Deltasone
    • Deltison
    • Deltra
    • Econosone
    • Lisacort
    • Meprosona-F
    • Metacortandracin
    • Meticorten
    • Ofisolona
    • Orasone
    • Panafcort
    • Panasol-S
    • Paracort
    • Perrigo Prednisone
    • PRED
    • Predicor
    • Predicorten
    • Prednicen-M
    • Prednicort
    • Prednidib
    • Prednilonga
    • Predniment
    • Prednisone Intensol
    • Prednisonum
    • Prednitone
    • Promifen
    • Rayos
    • Servisone
    • SK-Prednisone
  • Biological: Rituximab
    Given IV
    Other names:
    • ABP 798
    • BI 695500
    • C2B8 Monoclonal Antibody
    • Chimeric Anti-CD20 Antibody
    • CT-P10
    • IDEC-102
    • IDEC-C2B8
    • IDEC-C2B8 Monoclonal Antibody
    • MabThera
    • Monoclonal Antibody IDEC-C2B8
    • PF-05280586
    • Rituxan
    • Rituximab ABBS
    • Rituximab Biosimilar ABP 798
    • Rituximab Biosimilar BI 695500
    • Rituximab Biosimilar CT-P10
    • Rituximab Biosimilar GB241
    • Rituximab Biosimilar IBI301
    • Rituximab Biosimilar JHL1101
    • Rituximab Biosimilar PF-05280586
    • Rituximab Biosimilar RTXM83
    • Rituximab Biosimilar SAIT101
    • rituximab biosimilar TQB2303
    • rituximab-abbs
    • RTXM83
    • Truxima
  • Drug: Vincristine Sulfate
    Given IV
    Other names:
    • Kyocristine
    • Leurocristine sulfate
    • Leurocristine, sulfate
    • Oncovin
    • Vincasar
    • Vincosid
    • Vincrex
    • Vincristine, sulfate

Recruiting Locations

University of Alabama at Birmingham Cancer Center
Birmingham, Alabama 35233
Contact:
Site Public Contact
205-934-0220
tmyrick@uab.edu

Anchorage Associates in Radiation Medicine
Anchorage, Alaska 98508
Contact:
Site Public Contact
907-212-6871
AKPAMC.OncologyResearchSupport@providence.org

Anchorage Radiation Therapy Center
Anchorage, Alaska 99504
Contact:
Site Public Contact
907-212-6871
AKPAMC.OncologyResearchSupport@providence.org

Alaska Breast Care and Surgery LLC
Anchorage, Alaska 99508
Contact:
Site Public Contact
907-212-6871
AKPAMC.OncologyResearchSupport@providence.org

Alaska Oncology and Hematology LLC
Anchorage, Alaska 99508
Contact:
Site Public Contact
907-212-6871
AKPAMC.OncologyResearchSupport@providence.org

Alaska Women's Cancer Care
Anchorage, Alaska 99508
Contact:
Site Public Contact
907-212-6871
AKPAMC.OncologyResearchSupport@providence.org

Anchorage Oncology Centre
Anchorage, Alaska 99508
Contact:
Site Public Contact
907-212-6871
AKPAMC.OncologyResearchSupport@providence.org

Katmai Oncology Group
Anchorage, Alaska 99508
Contact:
Site Public Contact
907-212-6871
AKPAMC.OncologyResearchSupport@providence.org

Providence Alaska Medical Center
Anchorage, Alaska 99508
Contact:
Site Public Contact
907-212-6871
AKPAMC.OncologyResearchSupport@providence.org

Kingman Regional Medical Center
Kingman, Arizona 86401
Contact:
Site Public Contact
ecog.rss@jimmy.harvard.edu

Banner University Medical Center - Tucson
Tucson, Arizona 85719
Contact:
Site Public Contact
aselegue@email.arizona.edu

University of Arizona Cancer Center-North Campus
Tucson, Arizona 85719
Contact:
Site Public Contact
800-327-2873

Mercy Hospital Fort Smith
Fort Smith, Arkansas 72903
Contact:
Site Public Contact
800-378-9373

University of Arkansas for Medical Sciences
Little Rock, Arkansas 72205
Contact:
Site Public Contact
501-686-8274

PCR Oncology
Arroyo Grande, California 93420
Contact:
Site Public Contact
702-384-0013
research@sncrf.org

Providence Saint Joseph Medical Center/Disney Family Cancer Center
Burbank, California 91505
Contact:
Site Public Contact
818-847-4793
Najee.Boucher@providence.org

Community Cancer Institute
Clovis, California 93611
Contact:
Site Public Contact
559-387-1827

University Oncology Associates
Clovis, California 93611
Contact:
Site Public Contact
559-256-9680

UC San Diego Moores Cancer Center
La Jolla, California 92093
Contact:
Site Public Contact
858-822-5354
cancercto@ucsd.edu

UC Irvine Health/Chao Family Comprehensive Cancer Center
Orange, California 92868
Contact:
Site Public Contact
877-827-8839
ucstudy@uci.edu

Stanford Cancer Institute Palo Alto
Palo Alto, California 94304
Contact:
Site Public Contact
650-498-7061
ccto-office@stanford.edu

Rocky Mountain Cancer Centers-Aurora
Aurora, Colorado 80012
Contact:
Site Public Contact
303-777-2663
ccrp@co-cancerresearch.org

The Medical Center of Aurora
Aurora, Colorado 80012
Contact:
Site Public Contact
303-777-2663
ccrp@co-cancerresearch.org

Boulder Community Hospital
Boulder, Colorado 80301
Contact:
Site Public Contact
303-777-2663
jbloomfield@co-cancerresearch.org

Rocky Mountain Cancer Centers-Boulder
Boulder, Colorado 80304
Contact:
Site Public Contact
303-777-2663
ccrp@co-cancerresearch.org

Cancer Center of Colorado at Sloan's Lake
Denver, Colorado 80204
Contact:
Site Public Contact
303-777-2663

National Jewish Health-Main Campus
Denver, Colorado 80206
Contact:
Site Public Contact
877-225-5654
glicht@co-cancerresearch.org

The Women's Imaging Center
Denver, Colorado 80209
Contact:
Site Public Contact
303-777-2663
ccrp@co-cancerresearch.org

Colorado Blood Cancer Institute
Denver, Colorado 80218
Contact:
Site Public Contact
303-777-2663
ccrp@co-cancerresearch.org

Presbyterian - Saint Lukes Medical Center - Health One
Denver, Colorado 80218
Contact:
Site Public Contact
303-777-2663
ccrp@co-cancerresearch.org

Rocky Mountain Cancer Centers-Midtown
Denver, Colorado 80218
Contact:
Site Public Contact
303-777-2663
ccrp@co-cancerresearch.org

SCL Health Saint Joseph Hospital
Denver, Colorado 80218
Contact:
Site Public Contact
303-777-2663
ccrp@co-cancerresearch.org

Rocky Mountain Cancer Centers-Rose
Denver, Colorado 80220
Contact:
Site Public Contact
303-777-2663
ccrp@co-cancerresearch.org

Rose Medical Center
Denver, Colorado 80220
Contact:
Site Public Contact
303-777-2663
ccrp@co-cancerresearch.org

Western Surgical Care
Denver, Colorado 80220
Contact:
Site Public Contact
303-777-2663
ccrp@co-cancerresearch.org

Comprehensive Cancer Care and Research Institute of Colorado LLC
Englewood, Colorado 80113
Contact:
Site Public Contact
303-777-2663
ccrp@co-cancerresearch.org

Swedish Medical Center
Englewood, Colorado 80113
Contact:
Site Public Contact
303-777-2663
ccrp@co-cancerresearch.org

National Jewish Health-Western Hematology Oncology
Golden, Colorado 80401
Contact:
Site Public Contact
303-777-2663
glicht@co-cancerresearch.org

Saint Mary's Hospital and Regional Medical Center
Grand Junction, Colorado 81501
Contact:
Site Public Contact
303-777-2663
ccrp@co-cancerresearch.org

North Colorado Medical Center
Greeley, Colorado 80631
Contact:
Site Public Contact
303-777-2663
ccrp@co-cancerresearch.org

Good Samaritan Medical Center
Lafayette, Colorado 80026
Contact:
Site Public Contact
303-673-1622

Rocky Mountain Cancer Centers-Littleton
Littleton, Colorado 80120
Contact:
Site Public Contact
303-777-2663
ccrp@co-cancerresearch.org

Rocky Mountain Cancer Centers-Sky Ridge
Lone Tree, Colorado 80124
Contact:
Site Public Contact
303-777-2663
ccrp@co-cancerresearch.org

Sky Ridge Medical Center
Lone Tree, Colorado 80124
Contact:
Site Public Contact
303-777-2663
ccrp@co-cancerresearch.org

McKee Medical Center
Loveland, Colorado 80539
Contact:
Site Public Contact
303-777-2663
ccrp@co-cancerresearch.org

National Jewish Health-Northern Hematology Oncology
Thornton, Colorado 80260
Contact:
Site Public Contact
303-777-2663
glicht@co-cancerresearch.org

SCL Health Lutheran Medical Center
Wheat Ridge, Colorado 80033
Contact:
Site Public Contact
303-777-2663
ccrp@co-cancerresearch.org

Smilow Cancer Hospital Care Center at Saint Francis
Hartford, Connecticut 06105
Contact:
Site Public Contact
203-785-5702
canceranswers@yale.edu

Yale University
New Haven, Connecticut 06520
Contact:
Site Public Contact
203-785-5702
canceranswers@yale.edu

Smilow Cancer Hospital-Torrington Care Center
Torrington, Connecticut 06790
Contact:
Site Public Contact
203-785-5702
canceranswers@yale.edu

Baptist MD Anderson Cancer Center
Jacksonville, Florida 32207
Contact:
Site Public Contact
904-202-7051

Cleveland Clinic-Weston
Weston, Florida 33331
Contact:
Site Public Contact
954-659-5705
CancerAnswer@ccf.org

Emory University Hospital/Winship Cancer Institute
Atlanta, Georgia 30322
Contact:
Site Public Contact
404-778-1868

Northside Hospital
Atlanta, Georgia 30342
Contact:
Site Public Contact
404-303-3355
ClinicalTrials@northside.com

Saint Alphonsus Cancer Care Center-Boise
Boise, Idaho 83706
Contact:
Site Public Contact
734-712-3671
stephanie.couch@stjoeshealth.org

Saint Luke's Mountain States Tumor Institute
Boise, Idaho 83712
Contact:
Site Public Contact
208-381-2774
eslinget@slhs.org

Saint Alphonsus Cancer Care Center-Caldwell
Caldwell, Idaho 83605
Contact:
Site Public Contact
734-712-3671
stephanie.couch@stjoeshealth.org

Kootenai Medical Center
Coeur d'Alene, Idaho 83814
Contact:
Site Public Contact
406-969-6060
mccinfo@mtcancer.org

Walter Knox Memorial Hospital
Emmett, Idaho 83617
Contact:
Site Public Contact
734-712-3671
stephanie.couch@stjoeshealth.org

Saint Luke's Mountain States Tumor Institute - Fruitland
Fruitland, Idaho 83619
Contact:
Site Public Contact
208-381-8059
hallsc@slhs.org

Idaho Urologic Institute-Meridian
Meridian, Idaho 83642
Contact:
Site Public Contact
734-712-3671
stephanie.couch@stjoeshealth.org

Saint Luke's Mountain States Tumor Institute - Meridian
Meridian, Idaho 83642
Contact:
Site Public Contact
208-381-8059
hallsc@slhs.org

Saint Alphonsus Medical Center-Nampa
Nampa, Idaho 83686
Contact:
Site Public Contact
734-712-3671
stephanie.couch@stjoeshealth.org

Saint Luke's Mountain States Tumor Institute - Nampa
Nampa, Idaho 83686
Contact:
Site Public Contact
208-381-8059
hallsc@slhs.org

Kootenai Cancer Center
Post Falls, Idaho 83854
Contact:
Site Public Contact
406-969-6060
mccinfo@mtcancer.org

Kootenai Cancer Clinic
Sandpoint, Idaho 83864
Contact:
Site Public Contact
406-969-6060
mccinfo@mtcancer.org

Saint Luke's Mountain States Tumor Institute-Twin Falls
Twin Falls, Idaho 83301
Contact:
Site Public Contact
208-381-8059
hallsc@slhs.org

Illinois CancerCare-Bloomington
Bloomington, Illinois 61704
Contact:
Site Public Contact
309-243-3605
andersonj@illinoiscancercare.com

Illinois CancerCare-Canton
Canton, Illinois 61520
Contact:
Site Public Contact
309-243-3605
andersonj@illinoiscancercare.com

Memorial Hospital of Carbondale
Carbondale, Illinois 62902
Contact:
Site Public Contact
618-457-5200
clinical.research@sih.net

SIH Cancer Institute
Carterville, Illinois 62918
Contact:
Site Public Contact
618-985-3333
clinical.research@sih.net

Illinois CancerCare-Carthage
Carthage, Illinois 62321
Contact:
Site Public Contact
309-243-3605
andersonj@illinoiscancercare.com

Centralia Oncology Clinic
Centralia, Illinois 62801
Contact:
Site Public Contact
217-876-4740
rhamrick@dmhhs.org

Mount Sinai Hospital Medical Center
Chicago, Illinois 60608
Contact:
Site Public Contact
773-257-5960
suhi@sinai.org

Northwestern University
Chicago, Illinois 60611
Contact:
Site Public Contact
312-695-1301
cancer@northwestern.edu

University of Illinois
Chicago, Illinois 60612
Contact:
Site Public Contact
312-355-3046

University of Chicago Comprehensive Cancer Center
Chicago, Illinois 60637
Contact:
Site Public Contact
773-702-8222
cancerclinicaltrials@bsd.uchicago.edu

Cancer Care Specialists of Illinois - Decatur
Decatur, Illinois 62526
Contact:
Site Public Contact
217-876-4740
rhamrick@dmhhs.org

Decatur Memorial Hospital
Decatur, Illinois 62526
Contact:
Site Public Contact
217-876-4740
rhamrick@dmhhs.org

Illinois CancerCare-Dixon
Dixon, Illinois 61021
Contact:
Site Public Contact
815-285-7800

Crossroads Cancer Center
Effingham, Illinois 62401
Contact:
Site Public Contact
217-876-4740
rhamrick@dmhhs.org

Illinois CancerCare-Eureka
Eureka, Illinois 61530
Contact:
Site Public Contact
309-243-3605
andersonj@illinoiscancercare.com

NorthShore University HealthSystem-Evanston Hospital
Evanston, Illinois 60201
Contact:
Site Public Contact
847-570-2109

Illinois CancerCare-Galesburg
Galesburg, Illinois 61401
Contact:
Site Public Contact
309-243-3605
andersonj@illinoiscancercare.com

Western Illinois Cancer Treatment Center
Galesburg, Illinois 61401
Contact:
Site Public Contact
309-344-2831

NorthShore University HealthSystem-Glenbrook Hospital
Glenview, Illinois 60026
Contact:
Site Public Contact
847-570-2109

NorthShore University HealthSystem-Highland Park Hospital
Highland Park, Illinois 60035
Contact:
Site Public Contact
847-570-2109

Illinois CancerCare-Kewanee Clinic
Kewanee, Illinois 61443
Contact:
Site Public Contact
309-243-3605
andersonj@illinoiscancercare.com

Illinois CancerCare-Macomb
Macomb, Illinois 61455
Contact:
Site Public Contact
309-243-3605
andersonj@illinoiscancercare.com

Loyola University Medical Center
Maywood, Illinois 60153
Contact:
Site Public Contact
708-226-4357

Good Samaritan Regional Health Center
Mount Vernon, Illinois 62864
Contact:
Site Public Contact
618-242-4600

Illinois CancerCare-Ottawa Clinic
Ottawa, Illinois 61350
Contact:
Site Public Contact
309-243-3605
andersonj@illinoiscancercare.com

Illinois CancerCare-Pekin
Pekin, Illinois 61554
Contact:
Site Public Contact
309-243-3605
andersonj@illinoiscancercare.com

OSF Saint Francis Radiation Oncology at Pekin Cancer Treatment Center
Pekin, Illinois 61554
Contact:
Site Public Contact
309-243-3605
andersonj@illinoiscancercare.com

Illinois CancerCare-Peoria
Peoria, Illinois 61615
Contact:
Site Public Contact
309-243-3605
andersonj@illinoiscancercare.com

OSF Saint Francis Radiation Oncology at Peoria Cancer Center
Peoria, Illinois 61615
Contact:
Site Public Contact
309-243-3605
andersonj@illinoiscancercare.com

Methodist Medical Center of Illinois
Peoria, Illinois 61636
Contact:
Site Public Contact
309-243-3605
andersonj@illinoiscancercare.com

OSF Saint Francis Medical Center
Peoria, Illinois 61637
Contact:
Site Public Contact
309-243-3605
andersonj@illinoiscancercare.com

Illinois CancerCare-Peru
Peru, Illinois 61354
Contact:
Site Public Contact
309-243-3605
andersonj@illinoiscancercare.com

Valley Radiation Oncology
Peru, Illinois 61354
Contact:
Site Public Contact
815-664-4141

Illinois CancerCare-Princeton
Princeton, Illinois 61356
Contact:
Site Public Contact
309-243-3605
andersonj@illinoiscancercare.com

Southern Illinois University School of Medicine
Springfield, Illinois 62702
Contact:
Site Public Contact
217-545-7929

Springfield Clinic
Springfield, Illinois 62702
Contact:
Site Public Contact
800-444-7541

Memorial Medical Center
Springfield, Illinois 62781
Contact:
Site Public Contact
217-788-3528

Cancer Care Specialists of Illinois-Swansea
Swansea, Illinois 62226
Contact:
Site Public Contact
217-876-4740
rhamrick@dmhhs.org

Southwest Illinois Health Services LLP
Swansea, Illinois 62226
Contact:
Site Public Contact
618-236-1000
lynns@thecancercenter.com

Franciscan Health Indianapolis
Indianapolis, Indiana 46237
Contact:
Site Public Contact
317-528-7060

Franciscan Health Mooresville
Mooresville, Indiana 46158
Contact:
Site Public Contact
317-834-3603

Reid Health
Richmond, Indiana 47374
Contact:
Site Public Contact
937-775-1350
som_dcop@wright.edu

Mary Greeley Medical Center
Ames, Iowa 50010
Contact:
Site Public Contact
515-956-4132

McFarland Clinic PC - Ames
Ames, Iowa 50010
Contact:
Site Public Contact
515-956-4132

McFarland Clinic PC-Boone
Boone, Iowa 50036
Contact:
Site Public Contact
515-956-4132

McFarland Clinic PC-Trinity Cancer Center
Fort Dodge, Iowa 50501
Contact:
Site Public Contact
515-956-4132

McFarland Clinic PC-Jefferson
Jefferson, Iowa 50129
Contact:
Site Public Contact
515-956-4132

McFarland Clinic PC-Marshalltown
Marshalltown, Iowa 50158
Contact:
Site Public Contact
515-956-4132

Cancer Center of Kansas - Chanute
Chanute, Kansas 66720
Contact:
Site Public Contact
316-268-5374
Keisha.humphries@ascension.org

Cancer Center of Kansas - Dodge City
Dodge City, Kansas 67801
Contact:
Site Public Contact
316-268-5374
Keisha.humphries@ascension.org

Cancer Center of Kansas - El Dorado
El Dorado, Kansas 67042
Contact:
Site Public Contact
316-268-5374
Keisha.humphries@ascension.org

Cancer Center of Kansas-Independence
Independence, Kansas 67301
Contact:
Site Public Contact
316-268-5374
Keisha.humphries@ascension.org

University of Kansas Cancer Center
Kansas City, Kansas 66160
Contact:
Site Public Contact
913-945-7552
ctnursenav@kumc.edu

Cancer Center of Kansas-Kingman
Kingman, Kansas 67068
Contact:
Site Public Contact
316-268-5374
Keisha.humphries@ascension.org

Lawrence Memorial Hospital
Lawrence, Kansas 66044
Contact:
Site Public Contact
316-268-5374
Keisha.humphries@ascension.org

Cancer Center of Kansas-Liberal
Liberal, Kansas 67905
Contact:
Site Public Contact
316-268-5374
Keisha.humphries@ascension.org

Cancer Center of Kansas-Manhattan
Manhattan, Kansas 66502
Contact:
Site Public Contact
316-268-5784
Keisha.humphries@ascension.org

Cancer Center of Kansas - McPherson
McPherson, Kansas 67460
Contact:
Site Public Contact
316-268-5374
Keisha.humphries@ascension.org

Cancer Center of Kansas - Newton
Newton, Kansas 67114
Contact:
Site Public Contact
316-268-5374
Keisha.humphries@ascension.org

Olathe Medical Center
Olathe, Kansas 66061
Contact:
Site Public Contact
913-791-3500
Jeni.wakefield@olathehealth.org

Cancer Center of Kansas - Parsons
Parsons, Kansas 67357
Contact:
Site Public Contact
316-268-5374
Keisha.humphries@ascension.org

Cancer Center of Kansas - Pratt
Pratt, Kansas 67124
Contact:
Site Public Contact
316-268-5374
Keisha.humphries@ascension.org

Cancer Center of Kansas - Salina
Salina, Kansas 67401
Contact:
Site Public Contact
316-268-5374
Keisha.humphries@ascension.org

Cancer Center of Kansas - Wellington
Wellington, Kansas 67152
Contact:
Site Public Contact
316-268-5374
Keisha.humphries@ascension.org

University of Kansas Hospital-Westwood Cancer Center
Westwood, Kansas 66205
Contact:
Site Public Contact
913-945-7552
ctnursenav@kumc.edu

Cancer Center of Kansas-Wichita Medical Arts Tower
Wichita, Kansas 67208
Contact:
Site Public Contact
316-268-5374
Keisha.humphries@ascension.org

Ascension Via Christi Hospitals Wichita
Wichita, Kansas 67214
Contact:
Site Public Contact
800-362-0070
Keisha.humphries@ascension.org

Cancer Center of Kansas - Wichita
Wichita, Kansas 67214
Contact:
Site Public Contact
316-268-5374
Keisha.humphries@ascension.org

Cancer Center of Kansas - Winfield
Winfield, Kansas 67156
Contact:
Site Public Contact
316-268-5374
Keisha.humphries@ascension.org

The James Graham Brown Cancer Center at University of Louisville
Louisville, Kentucky 40202
Contact:
Site Public Contact
502-562-3429

Ochsner Health Center-Summa
Baton Rouge, Louisiana 70809
Contact:
Site Public Contact
225-761-5346
Camille.Beck@Ochsner.org

Medical Center of Baton Rouge
Baton Rouge, Louisiana 70816
Contact:
Site Public Contact
225-761-5346
Camille.Beck@Ochsner.org

Ochsner High Grove
Baton Rouge, Louisiana 70836
Contact:
Site Public Contact
504-703-8712
Gregory.Johnstone@ochsner.org

Ochsner Medical Center Jefferson
New Orleans, Louisiana 70121
Contact:
Site Public Contact
504-703-8712
Gregory.Johnstone@ochsner.org

Eastern Maine Medical Center
Bangor, Maine 04401
Contact:
Site Public Contact
207-973-4274

Lafayette Family Cancer Center-EMMC
Brewer, Maine 04412
Contact:
Site Public Contact
800-987-3005

University of Maryland/Greenebaum Cancer Center
Baltimore, Maryland 21201
Contact:
Site Public Contact
800-888-8823

Johns Hopkins University/Sidney Kimmel Cancer Center
Baltimore, Maryland 21287
Contact:
Site Public Contact
410-955-8804
jhcccro@jhmi.edu

Walter Reed National Military Medical Center
Bethesda, Maryland 20889-5600
Contact:
Site Public Contact
301-319-2100

Massachusetts General Hospital Cancer Center
Boston, Massachusetts 02114
Contact:
Site Public Contact
877-726-5130

Beth Israel Deaconess Medical Center
Boston, Massachusetts 02215
Contact:
Site Public Contact
617-667-9925

Dana-Farber Cancer Institute
Boston, Massachusetts 02215
Contact:
Site Public Contact
877-442-3324

Bronson Battle Creek
Battle Creek, Michigan 49017
Contact:
Site Public Contact
616-391-1230
crcwm-regulatory@crcwm.org

Henry Ford Cancer Institute-Downriver
Brownstown, Michigan 48183
Contact:
Site Public Contact
313-916-3721
CTOResearch@hfhs.org

Henry Ford Macomb Hospital-Clinton Township
Clinton Township, Michigan 48038
Contact:
Site Public Contact
313-916-3721
CTOResearch@hfhs.org

Beaumont Hospital - Dearborn
Dearborn, Michigan 48124
Contact:
Site Public Contact
248-551-7695

Henry Ford Medical Center-Fairlane
Dearborn, Michigan 48126
Contact:
Site Public Contact
313-916-3721
CTOResearch@hfhs.org

Wayne State University/Karmanos Cancer Institute
Detroit, Michigan 48201
Contact:
Site Public Contact
313-576-9790
ctoadmin@karmanos.org

Henry Ford Hospital
Detroit, Michigan 48202
Contact:
Site Public Contact
313-916-3721
CTOResearch@hfhs.org

Weisberg Cancer Treatment Center
Farmington Hills, Michigan 48334
Contact:
Site Public Contact
313-576-9790
ctoadmin@karmanos.org

Beaumont Hospital - Farmington Hills
Farmington Hills, Michigan 48336
Contact:
Site Public Contact
248-551-7695

Helen DeVos Children's Hospital at Spectrum Health
Grand Rapids, Michigan 49503
Contact:
Site Public Contact
616-391-1230
crcwm-regulatory@crcwm.org

Mercy Health Saint Mary's
Grand Rapids, Michigan 49503
Contact:
Site Public Contact
616-391-1230
crcwm-regulatory@crcwm.org

Spectrum Health at Butterworth Campus
Grand Rapids, Michigan 49503
Contact:
Site Public Contact
616-391-1230
crcwm-regulatory@crcwm.org

William Beaumont Hospital-Grosse Point
Grosse Pointe, Michigan 48230
Contact:
Site Public Contact
248-551-7695

Allegiance Health
Jackson, Michigan 49201
Contact:
Site Public Contact
313-916-3721
CTOResearch@hfhs.org

Bronson Methodist Hospital
Kalamazoo, Michigan 49007
Contact:
Site Public Contact
616-391-1230
crcwm-regulatory@crcwm.org

West Michigan Cancer Center
Kalamazoo, Michigan 49007
Contact:
Site Public Contact
616-391-1230
crcwm-regulatory@crcwm.org

Borgess Medical Center
Kalamazoo, Michigan 49048
Contact:
Site Public Contact
616-391-1230
crcwm-regulatory@crcwm.org

Mercy Health Mercy Campus
Muskegon, Michigan 49444
Contact:
Site Public Contact
616-391-1230
crcwm-regulatory@crcwm.org

Lakeland Hospital Niles
Niles, Michigan 49120
Contact:
Site Public Contact
616-391-1230

Henry Ford Medical Center-Columbus
Novi, Michigan 48377
Contact:
Site Public Contact
313-916-3721
CTOResearch@hfhs.org

Huron Medical Center PC
Port Huron, Michigan 48060
Contact:
Site Public Contact
702-384-0013
research@sncrf.org

Spectrum Health Reed City Hospital
Reed City, Michigan 49677
Contact:
Site Public Contact
616-391-1230
crcwm-regulatory@crcwm.org

Michigan Cancer Specialists
Roseville, Michigan 48066
Contact:
Site Public Contact
248-551-7695

Oakland Colon and Rectal Association
Royal Oak, Michigan 48067
Contact:
Site Public Contact
248-551-7695

Cancer Care Associates PC
Royal Oak, Michigan 48073
Contact:
Site Public Contact
248-551-7695

Comprehensive Medical Center PLLC
Royal Oak, Michigan 48073
Contact:
Site Public Contact
248-551-7695

Hematology Oncology Consultants PC
Royal Oak, Michigan 48073
Contact:
Site Public Contact
248-551-7695

Oakland Medical Group
Royal Oak, Michigan 48073
Contact:
Site Public Contact
248-551-7695

William Beaumont Hospital-Royal Oak
Royal Oak, Michigan 48073
Contact:
Site Public Contact
248-551-7695

Lakeland Medical Center Saint Joseph
Saint Joseph, Michigan 49085
Contact:
Site Public Contact
616-391-1230
crcwm-regulatory@crcwm.org

Marie Yeager Cancer Center
Saint Joseph, Michigan 49085
Contact:
Site Public Contact
616-391-1230
crcwm-regulatory@crcwm.org

Premier Hematology Oncology Care
Sterling Heights, Michigan 48312
Contact:
Site Public Contact
248-551-7695

Munson Medical Center
Traverse City, Michigan 49684
Contact:
Site Public Contact
616-391-1230
crcwm-regulatory@crcwm.org

Michigan Institute of Urology-Town Center
Troy, Michigan 48084
Contact:
Site Public Contact
248-551-7695

William Beaumont Hospital - Troy
Troy, Michigan 48085
Contact:
Site Public Contact
248-551-7695

Hematology Oncology Consultants PC-Troy
Troy, Michigan 48098
Contact:
Site Public Contact
248-551-7695

Henry Ford West Bloomfield Hospital
West Bloomfield, Michigan 48322
Contact:
Site Public Contact
313-916-3721
CTOResearch@hfhs.org

Metro Health Hospital
Wyoming, Michigan 49519
Contact:
Site Public Contact
616-391-1230
crcwm-regulatory@crcwm.org

Mayo Clinic
Rochester, Minnesota 55905
Contact:
Site Public Contact
855-776-0015

Saint Louis Cancer and Breast Institute-Ballwin
Ballwin, Missouri 63011
Contact:
Site Public Contact
314-251-7058

Parkland Health Center-Bonne Terre
Bonne Terre, Missouri 63628
Contact:
Site Public Contact
314-996-5569

Cox Cancer Center Branson
Branson, Missouri 65616
Contact:
Site Public Contact
417-269-4520

Saint Francis Medical Center
Cape Girardeau, Missouri 63703
Contact:
Site Public Contact
573-334-2230
sfmc@sfmc.net

Southeast Cancer Center
Cape Girardeau, Missouri 63703
Contact:
Site Public Contact
573-651-5550

Siteman Cancer Center at West County Hospital
Creve Coeur, Missouri 63141
Contact:
Site Public Contact
800-600-3606
info@siteman.wustl.edu

Capital Region Southwest Campus
Jefferson City, Missouri 65109
Contact:
Site Public Contact
573-632-4814
swooden@mail.crmc.org

Freeman Health System
Joplin, Missouri 64804
Contact:
Site Public Contact
417-347-4030
LJCrockett@freemanhealth.com

Mercy Hospital Joplin
Joplin, Missouri 64804
Contact:
Site Public Contact
417-556-3074
esmeralda.carrillo@mercy.net

Delbert Day Cancer Institute at PCRMC
Rolla, Missouri 65401
Contact:
Site Public Contact
573-458-7504
jrichards@research.pcrmc.com

Mercy Clinic-Rolla-Cancer and Hematology
Rolla, Missouri 65401
Contact:
Site Public Contact
573-458-7504
jrichards@research.pcrmc.com

Heartland Regional Medical Center
Saint Joseph, Missouri 64507
Contact:
Site Public Contact
816-271-7937
linda.schumacher@mymlc.com

Saint Louis Cancer and Breast Institute-South City
Saint Louis, Missouri 63109
Contact:
Site Public Contact
314-353-1870

Washington University School of Medicine
Saint Louis, Missouri 63110
Contact:
Site Public Contact
800-600-3606
info@siteman.wustl.edu

Mercy Hospital South
Saint Louis, Missouri 63128
Contact:
Site Public Contact
janet.lesko@mercy.net

Missouri Baptist Medical Center
Saint Louis, Missouri 63131
Contact:
Site Public Contact
314-996-5569

Mercy Hospital Saint Louis
Saint Louis, Missouri 63141
Contact:
Site Public Contact
314-251-7066

Siteman Cancer Center at Saint Peters Hospital
Saint Peters, Missouri 63376
Contact:
Site Public Contact
800-600-3606
info@siteman.wustl.edu

Sainte Genevieve County Memorial Hospital
Sainte Genevieve, Missouri 63670
Contact:
Site Public Contact
314-996-5569

Mercy Hospital Springfield
Springfield, Missouri 65804
Contact:
Site Public Contact
417-269-4520

CoxHealth South Hospital
Springfield, Missouri 65807
Contact:
Site Public Contact
417-269-4520

Missouri Baptist Sullivan Hospital
Sullivan, Missouri 63080
Contact:
Site Public Contact
314-996-5569

Missouri Baptist Outpatient Center-Sunset Hills
Sunset Hills, Missouri 63127
Contact:
Site Public Contact
314-996-5569

Mercy Hospital Washington
Washington, Missouri 63090
Contact:
Site Public Contact
636-390-1600

Community Hospital of Anaconda
Anaconda, Montana 59711
Contact:
Site Public Contact
406-969-6060
mccinfo@mtcancer.org

Billings Clinic Cancer Center
Billings, Montana 59101
Contact:
Site Public Contact
800-996-2663
research@billingsclinic.org

Bozeman Deaconess Hospital
Bozeman, Montana 59715
Contact:
Site Public Contact
406-969-6060
mccinfo@mtcancer.org

Saint James Community Hospital and Cancer Treatment Center
Butte, Montana 59701
Contact:
Site Public Contact
406-723-2621

Benefis Healthcare- Sletten Cancer Institute
Great Falls, Montana 59405
Contact:
Site Public Contact
406-969-6060
mccinfo@mtcancer.org

Great Falls Clinic
Great Falls, Montana 59405
Contact:
Site Public Contact
406-969-6060
mccinfo@mtcancer.org

Saint Peter's Community Hospital
Helena, Montana 59601
Contact:
Site Public Contact
406-969-6060
mccinfo@mtcancer.org

Kalispell Regional Medical Center
Kalispell, Montana 59901
Contact:
Site Public Contact
406-969-6060
mccinfo@mtcancer.org

Community Medical Hospital
Missoula, Montana 59804
Contact:
Site Public Contact
406-969-6060
mccinfo@mtcancer.org

Nebraska Medicine-Bellevue
Bellevue, Nebraska 68123
Contact:
Site Public Contact
402-559-6941
unmcrsa@unmc.edu

Nebraska Medicine-Village Pointe
Omaha, Nebraska 68118
Contact:
Site Public Contact
402-559-5600

University of Nebraska Medical Center
Omaha, Nebraska 68198
Contact:
Site Public Contact
402-559-6941
unmcrsa@unmc.edu

Carson Tahoe Regional Medical Center
Carson City, Nevada 89703
Contact:
Site Public Contact
702-384-0013
research@sncrf.org

Cancer and Blood Specialists-Henderson
Henderson, Nevada 89052
Contact:
Site Public Contact
702-384-0013
research@sncrf.org

Comprehensive Cancer Centers of Nevada - Henderson
Henderson, Nevada 89052
Contact:
Site Public Contact
702-384-0013
research@sncrf.org

Comprehensive Cancer Centers of Nevada-Horizon Ridge
Henderson, Nevada 89052
Contact:
Site Public Contact
702-384-0013
research@sncrf.org

Las Vegas Cancer Center-Henderson
Henderson, Nevada 89052
Contact:
Site Public Contact
702-384-0013
research@sncrf.org

OptumCare Cancer Care at Seven Hills
Henderson, Nevada 89052
Contact:
Site Public Contact
702-384-0013
research@sncrf.org

21st Century Oncology-Henderson
Henderson, Nevada 89074
Contact:
Site Public Contact
702-384-0013
research@sncrf.org

Comprehensive Cancer Centers of Nevada-Southeast Henderson
Henderson, Nevada 89074
Contact:
Site Public Contact
702-384-0013
research@sncrf.org

Las Vegas Urology - Pebble
Henderson, Nevada 89074
Contact:
Site Public Contact
research@sncrf.org

Las Vegas Urology - Pecos
Las Vegas, Nevada 89074
Contact:
Site Public Contact
research@sncrf.org

Desert West Surgery
Las Vegas, Nevada 89102
Contact:
Site Public Contact
702-384-0013
research@sncrf.org

University Medical Center of Southern Nevada
Las Vegas, Nevada 89102
Contact:
Site Public Contact
702-384-0013
research@sncrf.org

Hope Cancer Care of Nevada
Las Vegas, Nevada 89103
Contact:
Site Public Contact
702-384-0013
research@sncrf.org

Cancer and Blood Specialists-Shadow
Las Vegas, Nevada 89106
Contact:
Site Public Contact
702-384-0013
research@sncrf.org

OptumCare Cancer Care at Oakey
Las Vegas, Nevada 89106
Contact:
Site Public Contact
702-384-0013
research@sncrf.org

Radiation Oncology Centers of Nevada Central
Las Vegas, Nevada 89106
Contact:
Site Public Contact
702-384-0013
research@sncrf.org

21st Century Oncology
Las Vegas, Nevada 89109
Contact:
Site Public Contact
702-384-0013
research@sncrf.org

HealthCare Partners Medical Group Oncology/Hematology-Maryland Parkway
Las Vegas, Nevada 89109
Contact:
Site Public Contact
702-384-0013
research@sncrf.org

Sunrise Hospital and Medical Center
Las Vegas, Nevada 89109
Contact:
Site Public Contact
702-384-0013
research@sncrf.org

HealthCare Partners Medical Group Oncology/Hematology-San Martin
Las Vegas, Nevada 89113
Contact:
Site Public Contact
702-384-0013
research@sncrf.org

Radiation Oncology Centers of Nevada Southeast
Las Vegas, Nevada 89119
Contact:
Site Public Contact
702-384-0013
research@sncrf.org

21st Century Oncology-Vegas Tenaya
Las Vegas, Nevada 89128
Contact:
Site Public Contact
702-384-0013
research@sncrf.org

Ann M Wierman MD LTD
Las Vegas, Nevada 89128
Contact:
Site Public Contact
702-384-0013
research@sncrf.org

Cancer and Blood Specialists-Tenaya
Las Vegas, Nevada 89128
Contact:
Site Public Contact
702-384-0013
research@sncrf.org

Comprehensive Cancer Centers of Nevada - Northwest
Las Vegas, Nevada 89128
Contact:
Site Public Contact
702-384-0013
research@sncrf.org

HealthCare Partners Medical Group Oncology/Hematology-Tenaya
Las Vegas, Nevada 89128
Contact:
Site Public Contact
702-384-0013
research@sncrf.org

Las Vegas Urology - Cathedral Rock
Las Vegas, Nevada 89128
Contact:
Site Public Contact
research@sncrf.org

Las Vegas Urology - Smoke Ranch
Las Vegas, Nevada 89128
Contact:
Site Public Contact
research@smcrf.org

OptumCare Cancer Care at MountainView
Las Vegas, Nevada 89128
Contact:
Site Public Contact
702-384-0013
research@sncrf.org

Alliance for Childhood Diseases/Cure 4 the Kids Foundation
Las Vegas, Nevada 89135
Contact:
Site Public Contact
702-384-0013
research@sncrf.org

Comprehensive Cancer Centers of Nevada - Town Center
Las Vegas, Nevada 89144
Contact:
Site Public Contact
702-384-0013
research@sncrf.org

Comprehensive Cancer Centers of Nevada-Summerlin
Las Vegas, Nevada 89144
Contact:
Site Public Contact
702-384-0013
research@sncrf.org

Summerlin Hospital Medical Center
Las Vegas, Nevada 89144
Contact:
Site Public Contact
702-384-0013
research@sncrf.org

Las Vegas Cancer Center-Medical Center
Las Vegas, Nevada 89148-2405
Contact:
Site Public Contact
702-384-0013
research@sncrf.org

21st Century Oncology-Fort Apache
Las Vegas, Nevada 89148
Contact:
Site Public Contact
702-384-0013
research@sncrf.org

Comprehensive Cancer Centers of Nevada
Las Vegas, Nevada 89148
Contact:
Site Public Contact
702-384-0013
research@sncrf.org

OptumCare Cancer Care at Fort Apache
Las Vegas, Nevada 89148
Contact:
Site Public Contact
702-384-0013
research@sncrf.org

HealthCare Partners Medical Group Oncology/Hematology-Centennial Hills
Las Vegas, Nevada 89149
Contact:
Site Public Contact
702-384-0013
research@sncrf.org

Comprehensive Cancer Centers of Nevada - Central Valley
Las Vegas, Nevada 89169
Contact:
Site Public Contact
702-384-0013
research@sncrf.org

University Cancer Center
Las Vegas, Nevada 89169
Contact:
Site Public Contact
702-384-0013
research@sncrf.org

Hope Cancer Care of Nevada-Pahrump
Pahrump, Nevada 89048
Contact:
Site Public Contact
702-384-0013
research@sncrf.org

Renown Regional Medical Center
Reno, Nevada 89502
Contact:
Site Public Contact
702-384-0013
research@sncrf.org

Saint Mary's Regional Medical Center
Reno, Nevada 89503
Contact:
Site Public Contact
702-384-0013
research@sncrf.org

Radiation Oncology Associates
Reno, Nevada 89509
Contact:
Site Public Contact
702-384-0013
research@sncrf.org

Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire 03756
Contact:
Site Public Contact
800-639-6918
cancer.research.nurse@dartmouth.edu

Memorial Sloan Kettering Basking Ridge
Basking Ridge, New Jersey 07920
Contact:
Site Public Contact
212-639-7592

Memorial Sloan Kettering Monmouth
Middletown, New Jersey 07748
Contact:
Site Public Contact
212-639-7592

Memorial Sloan Kettering Bergen
Montvale, New Jersey 07645
Contact:
Site Public Contact
212-639-7592

Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey 08903
Contact:
Site Public Contact
732-235-8675

Roswell Park Cancer Institute
Buffalo, New York 14263
Contact:
Site Public Contact
800-767-9355
askroswell@roswellpark.org

Memorial Sloan Kettering Commack
Commack, New York 11725
Contact:
Site Public Contact
212-639-7592

Memorial Sloan Kettering Westchester
Harrison, New York 10604
Contact:
Site Public Contact
212-639-7592

Northwell Health/Center for Advanced Medicine
Lake Success, New York 11042
Contact:
Site Public Contact
516-734-8896

North Shore University Hospital
Manhasset, New York 11030
Contact:
Site Public Contact
516-734-8896

Long Island Jewish Medical Center
New Hyde Park, New York 11040
Contact:
Site Public Contact
516-734-8896

Memorial Sloan Kettering Cancer Center
New York, New York 10065
Contact:
Site Public Contact
212-639-7592

Memorial Sloan Kettering Nassau
Uniondale, New York 11553
Contact:
Site Public Contact
212-639-7592

AdventHealth Infusion Center Asheville
Asheville, North Carolina 28803
Contact:
Site Public Contact
828-650-8037
Heather.M.Duncan@AdventHealth.com

UNC Lineberger Comprehensive Cancer Center
Chapel Hill, North Carolina 27599
Contact:
Site Public Contact
877-668-0683
cancerclinicaltrials@med.unc.edu

AdventHealth Hendersonville
Hendersonville, North Carolina 28792
Contact:
Site Public Contact
828-650-8037
Heather.M.Duncan@AdventHealth.com

Wake Forest University Health Sciences
Winston-Salem, North Carolina 27157
Contact:
Site Public Contact
336-713-6771

Indu and Raj Soin Medical Center
Beavercreek, Ohio 45431
Contact:
Site Public Contact
937-775-1350
som_dcop@wright.edu

Saint Elizabeth Boardman Hospital
Boardman, Ohio 44512
Contact:
Site Public Contact
937-775-1350
som_dcop@wright.edu

Dayton Physicians LLC-Miami Valley South
Centerville, Ohio 45459
Contact:
Site Public Contact
937-775-1350
som_dcop@wright.edu

Miami Valley Hospital South
Centerville, Ohio 45459
Contact:
Site Public Contact
937-775-1350
som_dcop@wright.edu

Oncology Hematology Care Inc-Kenwood
Cincinnati, Ohio 45236
Contact:
Site Public Contact
937-775-1350
som_dcop@wright.edu

Cleveland Clinic Foundation
Cleveland, Ohio 44195
Contact:
Site Public Contact
866-223-8100
CancerAnswer@ccf.org

Ohio State University Comprehensive Cancer Center
Columbus, Ohio 43210
Contact:
Site Public Contact
800-293-5066
Jamesline@osumc.edu

Good Samaritan Hospital - Dayton
Dayton, Ohio 45406
Contact:
Site Public Contact
937-775-1350
som_dcop@wright.edu

Miami Valley Hospital
Dayton, Ohio 45409
Contact:
Site Public Contact
937-775-1350
som_dcop@wright.edu

Dayton Physician LLC-Miami Valley Hospital North
Dayton, Ohio 45415
Contact:
Site Public Contact
937-775-1350
som_dcop@wright.edu

Miami Valley Hospital North
Dayton, Ohio 45415
Contact:
Site Public Contact
937-775-1350
som_dcop@wright.edu

Armes Family Cancer Center
Findlay, Ohio 45840
Contact:
Site Public Contact
937-775-1350
som_dcop@wright.edu

Blanchard Valley Hospital
Findlay, Ohio 45840
Contact:
Site Public Contact
937-775-1350
som_dcop@wright.edu

Orion Cancer Care
Findlay, Ohio 45840
Contact:
Site Public Contact
937-775-1350
som_dcop@wright.edu

Atrium Medical Center-Middletown Regional Hospital
Franklin, Ohio 45005-1066
Contact:
Site Public Contact
937-775-1350
som_dcop@wright.edu

Dayton Physicians LLC-Atrium
Franklin, Ohio 45005
Contact:
Site Public Contact
937-775-1350
som_dcop@wright.edu

Dayton Physicians LLC-Wayne
Greenville, Ohio 45331
Contact:
Site Public Contact
937-775-1350
som_dcop@wright.edu

Wayne Hospital
Greenville, Ohio 45331
Contact:
Site Public Contact
937-775-1350
som_dcop@wright.edu

Greater Dayton Cancer Center
Kettering, Ohio 45409
Contact:
Site Public Contact
937-775-1350
som_dcop@wright.edu

First Dayton Cancer Care
Kettering, Ohio 45420
Contact:
Site Public Contact
937-775-1350
som_dcop@wright.edu

Kettering Medical Center
Kettering, Ohio 45429
Contact:
Site Public Contact
937-775-1350
som_dcop@wright.edu

Springfield Regional Cancer Center
Springfield, Ohio 45504
Contact:
Site Public Contact
937-775-1350
som_dcop@wright.edu

Springfield Regional Medical Center
Springfield, Ohio 45505
Contact:
Site Public Contact
937-775-1350
som_dcop@wright.edu

Dayton Physicians LLC-Upper Valley
Troy, Ohio 45373
Contact:
Site Public Contact
937-775-1350
som_dcop@wright.edu

Upper Valley Medical Center
Troy, Ohio 45373
Contact:
Site Public Contact
937-775-1350
som_dcop@wright.edu

Saint Joseph Warren Hospital
Warren, Ohio 44484
Contact:
Site Public Contact
937-775-1350
som_dcop@wright.edu

Saint Elizabeth Youngstown Hospital
Youngstown, Ohio 44501
Contact:
Site Public Contact
937-775-1350
som_dcop@wright.edu

University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma 73104
Contact:
Site Public Contact
405-271-8777
ou-clinical-trials@ouhsc.edu

Mercy Hospital Oklahoma City
Oklahoma City, Oklahoma 73120
Contact:
Site Public Contact
405-752-3402

Saint Alphonsus Medical Center-Baker City
Baker City, Oregon 97814
Contact:
Site Public Contact
734-712-3671
stephanie.couch@stjoeshealth.org

Saint Charles Health System
Bend, Oregon 97701
Contact:
Site Public Contact
541-706-2909
nosall@stcharleshealthcare.org

Clackamas Radiation Oncology Center
Clackamas, Oregon 97015
Contact:
Site Public Contact
503-215-2614
CanRsrchStudies@providence.org

Providence Oncology and Hematology Care Southeast
Clackamas, Oregon 97015
Contact:
Site Public Contact
503-215-2614
CanRsrchStudies@providence.org

Bay Area Hospital
Coos Bay, Oregon 97420
Contact:
Site Public Contact
541-269-8392
cherie.cox@bayareahospital.org

Providence Newberg Medical Center
Newberg, Oregon 97132
Contact:
Site Public Contact
503-215-2614
CanRsrchStudies@providence.org

Saint Alphonsus Medical Center-Ontario
Ontario, Oregon 97914
Contact:
Site Public Contact
734-712-3671
stephanie.couch@stjoeshealth.org

Providence Portland Medical Center
Portland, Oregon 97213
Contact:
Site Public Contact
503-215-2614
CanRsrchStudies@providence.org

Providence Saint Vincent Medical Center
Portland, Oregon 97225
Contact:
Site Public Contact
503-215-2614
CanRsrchStudies@providence.org

Saint Charles Health System-Redmond
Redmond, Oregon 97756
Contact:
Site Public Contact
541-706-2909

Geisinger Medical Center
Danville, Pennsylvania 17822
Contact:
Site Public Contact
570-271-5251
HemonCCTrials@geisinger.edu

Penn State Milton S Hershey Medical Center
Hershey, Pennsylvania 17033-0850
Contact:
Site Public Contact
717-531-3779
CTO@hmc.psu.edu

University of Pennsylvania/Abramson Cancer Center
Philadelphia, Pennsylvania 19104
Contact:
Site Public Contact
800-474-9892

Thomas Jefferson University Hospital
Philadelphia, Pennsylvania 19107
Contact:
Site Public Contact
215-955-6084

Community Medical Center
Scranton, Pennsylvania 18510
Contact:
Site Public Contact
570-703-4768
HemonCCTrials@geisinger.edu

Greenville Health System Cancer Institute-Easley
Easley, South Carolina 29640
Contact:
Site Public Contact
864-241-6251
kwilliams8@ghs.org

Saint Francis Hospital
Greenville, South Carolina 29601
Contact:
Site Public Contact
864-603-6213
meissa_beckman@bshsi.org

Greenville Health System Cancer Institute-Butternut
Greenville, South Carolina 29605
Contact:
Site Public Contact
864-241-6251
kwilliams8@ghs.org

Greenville Health System Cancer Institute-Faris
Greenville, South Carolina 29605
Contact:
Site Public Contact
864-241-6251
kwilliams8@ghs.org

Greenville Memorial Hospital
Greenville, South Carolina 29605
Contact:
Site Public Contact
864-241-6251
kwilliams8@ghs.org

Saint Francis Cancer Center
Greenville, South Carolina 29607
Contact:
Site Public Contact
864-603-6213
meissa_beckman@bshsi.org

Greenville Health System Cancer Institute-Eastside
Greenville, South Carolina 29615
Contact:
Site Public Contact
864-241-6251
kwilliams8@ghs.org

Greenville Health System Cancer Institute-Greer
Greer, South Carolina 29650
Contact:
Site Public Contact
864-241-6251
kwilliams8@ghs.org

Greenville Health System Cancer Institute-Seneca
Seneca, South Carolina 29672
Contact:
Site Public Contact
864-241-6251
kwilliams8@ghs.org

Greenville Health System Cancer Institute-Spartanburg
Spartanburg, South Carolina 29307
Contact:
Site Public Contact
864-241-6251
kwilliams8@ghs.org

Parkland Memorial Hospital
Dallas, Texas 75235
Contact:
Site Public Contact
214-590-5582
canceranswerline@UTSouthwestern.edu

UT Southwestern/Simmons Cancer Center-Dallas
Dallas, Texas 75390
Contact:
Site Public Contact
214-648-7097
canceranswerline@UTSouthwestern.edu

American Fork Hospital / Huntsman Intermountain Cancer Center
American Fork, Utah 84003
Contact:
Site Public Contact
801-855-4100
officeofresearch@imail.org

Sandra L Maxwell Cancer Center
Cedar City, Utah 84720
Contact:
Site Public Contact
435-868-5680
officeofresearch@imail.org

Farmington Health Center
Farmington, Utah 84025
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Richmond, Virginia 23235
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Richmond, Virginia 23298
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Eau Claire, Wisconsin 54701
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Green Bay, Wisconsin 54303
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La Crosse, Wisconsin 54601
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Madison, Wisconsin 53792
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Milwaukee, Wisconsin 53226
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Minocqua, Wisconsin 54548
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Stevens Point, Wisconsin 54482
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Cheyenne, Wyoming 82001
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Billings Clinic-Cody
Cody, Wyoming 82414
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Welch Cancer Center
Sheridan, Wyoming 82801
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Cancer Center-Metro Medical Center Bayamon
Bayamon, Puerto Rico 00959-5060
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Doctors Cancer Center
Manati, Puerto Rico 00674
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San Juan Community Oncology Group
San Juan, Puerto Rico 00917
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San Juan City Hospital
San Juan, Puerto Rico 00936
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More Details

NCT ID
NCT02003222
Status
Recruiting
Sponsor
National Cancer Institute (NCI)

Detailed Description

PRIMARY OBJECTIVES:

I. To compare the overall survival (OS) of blinatumomab in conjunction with chemotherapy to chemotherapy alone in patients with BCR-ABL-negative B cell precursor acute lymphoblastic leukemia (ALL) who are minimal residual disease (MRD) positive after induction and intensification chemotherapy, based on multiparameter flow cytometric (MFC) assessment of residual blasts.

SECONDARY OBJECTIVES:

I. To compare the relapse-free survival (RFS) of blinatumomab in conjunction with chemotherapy to chemotherapy alone in MRD positive patients, MRD negative patients and overall population after induction and intensification chemotherapy.

II. To compare the OS and RFS of those patients who are MRD+ at step 3 randomization/ registration and then convert to MRD- after 2 cycles of blinatumomab to those patients who are MRD- at randomization and remain MRD- after 2 cycles of blinatumomab or consolidation chemotherapy.

III. To assess the toxicities of blinatumomab in this patient population. IV. To assess the toxicities of the modified E2993 chemotherapy regimen in this patient population.

V. To describe the outcome of patients who proceed to allogeneic blood or marrow transplant after treatment with or without blinatumomab.

LABORATORY OBJECTIVES:

I. To determine differences in MRD kinetics among patients with the BCR/ABL1-like B-lineage ALL, and assess the efficacy of blinatumomab in each molecular subgroup.

II. To evaluate the incidence of anti-blinatumomab antibody formation.

OUTLINE:

INDUCTION CHEMOTHERAPY: Patients receive cytarabine intrathecally (IT) on day 1; daunorubicin hydrochloride intravenously (IV) over 10-15 minutes on days 1, 8, 15, and 22; vincristine sulfate IV on days 1, 8, 15, and 22; dexamethasone orally (PO) daily on days 1-7 (and 15-21 for patients age < 55 years only); methotrexate IT on day 14; pegaspargase intramuscularly (IM) or IV on day 18 (patients age =< 55 years); and CD20 positive patients may optionally receive rituximab IV on day 8 and 15. Beginning on day 29, patients with absolute neutrophil count (ANC) >= 0.75 x 10^9/L and platelets > 75 x 10^9/L (patients with delayed hematologic recovery) (patients with residual disease that is delaying count begin treatment immediately) receive cyclophosphamide IV over 30 minutes on days 1 and 29, cytarabine IV over 30 minutes or subcutaneously (SC) on days 1-4, 8-11, 29-32, and 36-39, mercaptopurine PO on days 1-14, 29-42, pegaspargase IM or IV on day 15 (patients age < 55 years), patients receiving treatment for central nervous system (CNS) 2 or 3 leukemia in course 1 receive methotrexate IT on days 1, 8, 15, and 22, and CD20 positive patients may optionally receive rituximab IV on days 8 and 15.

INTENSIFICATION THERAPY: Beginning 4 weeks after the completion of course 2 of induction therapy, patients receive intensification therapy comprising high-dose methotrexate IV over 2 hours on days 1 and 8, and pegaspargase IM or IV on day 9.

Patients are then randomized to 1 of 2 treatment arms.

Patients randomized to the blinatumomab group receive blinatumomab IV continuously on days 1-28. Treatment repeats every 6 weeks for 2 courses in the absence of disease progression or unacceptable toxicity. Patients may then undergo allogeneic stem cell transplant (SCT) or proceed to consolidation therapy per investigator discretion.

CONSOLIDATION THERAPY: Beginning after the second course of blinatumomab (patients randomized to the blinatumomab group) or after intensification therapy (patients not randomized to blinatumomab), patients receive cytarabine IV over 30 minutes or SC on days 1-5, etoposide IV over 1 hour on days 1-5, methotrexate IT on day 1, and pegaspargase IM or IV on day 5, and CD20 positive patients may optionally receive rituximab IV on day 5. Beginning 4 weeks from day 1 of course 1, patients receive cytarabine, etoposide, methotrexate, and CD20 positive patients may receive rituximab as in course 1. Beginning 4 weeks from day 1 of course 2, patients receive daunorubicin hydrochloride IV over 10-15 minutes on day 1, 8, 15, and 22; vincristine sulfate IV on days 1, 8, 15, and 22; dexamethasone PO daily on days 1-7 (and 15-21 for patients age < 55 years); methotrexate IT on day 2; cyclophosphamide PO or IV over 30 minutes on day 29; cytarabine IV over 30 minutes or SC on days 30-33 and 37-40; mercaptopurine PO on days 29-42 and CD20 positive patients may receive rituximab on day 8. Beginning 8 weeks from day 1 of course 3, patients receive cytarabine, etoposide, methotrexate, and CD20 positive patients may optionally receive rituximab as in course 1. Patients randomized to blinatumomab repeat course 4 and then receive blinatumomab IV continuously on days 1-28.

MAINTENANCE THERAPY: Within 12 weeks after beginning last course of consolidation therapy, patients receive mercaptopurine PO daily, methotrexate PO or IV over 6 hours once weekly for 2.5 years, vincristine sulfate IV on day 1 every 3 months, prednisone PO on days 1-5 every 3 months, and methotrexate IT on day 1 every 3 months. Treatment continues for up to 2.5 years in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up every 3 months for 2 years, every 6 months for 3 years, and then every 12 months for 5 years.

Notice

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