Comparing Cytarabine + Daunorubicin Therapy Versus Cytarabine + Daunorubicin + Venetoclax Versus Venetoclax + Azacitidine in Younger Patients With Intermediate Risk AML (A MyeloMATCH Treatment Trial)
Purpose
This phase II MyeloMATCH treatment trial compares cytarabine with daunorubicin versus cytarabine with daunorubicin and venetoclax versus venetoclax with azacitidine for the treatment of younger patients with intermediate risk acute myeloid leukemia (AML). Cytarabine is a drug that inhibits some of the enzymes needed for deoxyribonucleic acid (DNA) replication and repair and can slow or stop the growth of cancer cells. Daunorubicin is a drug that blocks a certain enzyme needed for cell division and DNA repair, and it may kill cancer cells. Venetoclax is in a class of medications called B-cell lymphoma-2 (BCL-2) inhibitors. It may stop the growth of cancer cells by blocking Bcl-2, a protein needed for cancer cell survival. Azacitidine is a drug that interacts with DNA to activate tumor-suppressing genes, resulting in an anti-tumor effect. Adding venetoclax to cytarabine and daunorubicin, and adding venetoclax to azacitidine, may work better than the usual treatment of cytarabine with daunorubicin alone. To decide if they are better, the study doctors are looking to see if venetoclax increases the rate of elimination of AML in participants by 20% or more compared to the usual approach.
Condition
- Acute Myeloid Leukemia
Eligibility
- Eligible Ages
- Between 18 Years and 59 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Patient must have enrolled onto MYELOMATCH and must have been given a treatment assignment to MyeloMATCH to MM1YA-CTG01 based on the presence of an actionable mutation as defined in MYELOMATCH - Participants must have been registered to master screening and re-assessment protocol (myeloMATCH MSRP) prior to consenting to this study. Participants must have been assigned to this clinical trial, via MATCHBox Protocol Assignment Team, prior to registration to this study. Participants must have agreed to have specimens submitted for translational medicine (MRD) and must be offered the opportunity to submit biosamples for banking for future research as per the myeloMATCH MSRP - Note: Pre-enrollment/diagnosis labs must have already been performed under the MSRP - Previously untreated, de novo acute myeloid leukemia (AML) defined by > 20% myeloblasts in the peripheral blood or bone marrow (refer to the 2016 updated World Health Organization [WHO] classification of myeloid neoplasms and acute leukemia) excluding all the following categories of AML: - Favorable cytogenetics: (t(8;21)q22;q22.1); RUNX1-RUNX1T1, inversion 16(p13.1;q22), t(16;16)(p13.1;q22); CBFB-MYH11 - CEBPA biallelic mutations - NPM1 mutation - AML with PML-RARalpha - AML with any adverse cytogenetics, TP53 mutation, RUNX1 mutation, ASXL1, 11q23/KMT2 rearrangements - AML with FLT3-ITD or FLT3-TKD mutations - Therapy related AML, or AML following a diagnosis of myelodysplasia or myeloproliferative neoplasm Participants with central nervous system (CNS) disease are eligible for this trial and will be treated according to institutional guidelines with intrathecal chemotherapy for this aspect of their disease - Age 18-59 years at time of induction therapy - Eastern Cooperative Oncology Group (ECOG) performance status =< 3 - Total bilirubin =< 2 x institutional upper limit of normal (ULN) (must be done within 7 days of enrollment) - Aspartate aminotransferase (AST) (serum glutamate pyruvate transaminase [SGPT]) +/or alanine aminotransferase (ALT) (serum glutamic-oxaloacetic transaminase [SGOT]) =< 3 × institutional ULN (must be done within 7 days of enrollment) - Cardiac ejection fraction >= 50% (echocardiography or multigated acquisition scan [MUGA]) (if clinically indicated must be done within 14 days of enrollment) - Calculated creatinine clearance >= 30 mL/min/ 1.73m^2; Clearance to be calculated using Cockcroft formula (must be done within 7 days of enrollment) - White blood cells (WBC) must be < 25 x 10^9/L. Hydroxyurea and leukapheresis are permitted to control the WBC prior to enrollment and initiation of protocol-defined therapy but must be stopped at least 24 hours prior to the initiation of protocol therapy. 1 dose of cytarabine at 1 mg/m^2 for urgent cytoreduction is also permitted - Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial - Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, patients should be class 2B or better - Males and females of reproductive potential must have agreed to use a highly effective contraceptive method while on treatment and for 6 months after stopping study drug. A woman is considered to be of "childbearing potential" if she has had menses at any time in the preceding 12 consecutive months. In addition to routine contraceptive methods, "effective contraception" also includes heterosexual celibacy and surgery intended to prevent pregnancy (or with a side-effect of pregnancy prevention) defined as a hysterectomy, bilateral oophorectomy or bilateral tubal ligation, or vasectomy/vasectomized partner. However, if at any point a previously celibate patient chooses to become heterosexually active during the time period for use of contraceptive measures outlined in the protocol, he/she is responsible for beginning contraceptive measures. Women of childbearing potential will have a pregnancy test to determine eligibility as part of the pre-study evaluation; this may include an ultrasound to rule-out pregnancy if a false-positive is suspected. Patient will be considered eligible if an ultrasound is negative for pregnancy - Patient consent must be appropriately obtained in accordance with applicable local and regulatory requirements. Each patient must sign a consent form prior to enrollment in the trial to document their willingness to participate - Patients must be accessible for treatment, response assessment and follow up. Patients enrolled on this trial must be treated and followed at the participating centre. Investigators must assure themselves the patients enrolled on this trial will be available for complete documentation of the treatment, adverse events, and follow-up. Patients must agree to return to their primary care facility for any adverse events which may occur through the course of the trial - In accordance with Canadian Cancer Trials Group (CCTG) policy, protocol treatment is to begin within 7 working days of patient enrollment - Participants receiving strong or moderate CYP3A inhibitors must agree to discontinue use at least 48 hours prior to start of study treatment if assigned to arm 1 or 2 - Patients with known human immunodeficiency virus (HIV) infection who are on effective anti-retroviral therapy and have undetectable viral load within 6 months of enrollment are eligible for this trial - Participants with evidence of chronic hepatitis B virus (HBV) infection must have undetectable HBV viral load within 28 days of enrollment. Patients need to be on suppressive therapy, if indicated - Patients with a history of hepatitis C virus (HCV) infection who have been treated and cured are eligible. Patients who with active HCV infection who are currently being treated must have an undetectable HCV viral load within 28 days of enrollment to be eligible
Exclusion Criteria
- Prior therapy for AML except for hydroxyurea and leukapheresis to control blood counts. The use of all-trans retinoic acid (ATRA) is permitted until a diagnosis of acute promyelocytic leukemia, if suspected, is ruled out - Patients who are receiving any other investigational agents - History of allergic reactions attributed to compounds of similar chemical or biologic composition to cytarabine, daunorubicin, azacitidine, venetoclax - Pregnant women are excluded from this study because venetoclax, cytarabine and azacitidine have the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with venetoclax, cytarabine and azacitidine breastfeeding should be discontinued if the mother is treated with venetoclax, cytarabine and azacitidine. These potential risks may also apply to other agents used in this study - Patients with isolated myeloid sarcoma are not eligible - Any other serious intercurrent illness, life threatening condition, organ system dysfunction, or medical condition judged by the local investigator to compromise the subject's safety (for example): - Active, uncontrolled bacterial, fungal, or viral infection
Study Design
- Phase
- Phase 2
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental ARM I (daunorubicin, cytarabine, venetoclax) |
Patients receive daunorubicin IV on days 2-4, cytarabine IV continuously on days 2-8, and venetoclax PO QD on days 1-11. Cycle is 28 days and treatment is given in the absence of disease progression or unacceptable toxicity. Based on a bone marrow aspiration assessment (completed at the discretion of the treating investigator), patients may receive reinduction consisting of daunorubicin IV on days 2-3, cytarabine IV continuously on days 2-6, and venetoclax PO QD on days 1-8. Cycle is 28 days and treatment is given in the absence of disease progression or unacceptable toxicity. Patients also undergo bone marrow aspiration and collection of blood samples on study and as clinically indicated. |
|
|
Experimental ARM II (azacitidine, venetoclax) |
Patients receive azacitidine IV or SC on days 1-7 or days 1-5 and 8-9 and venetoclax PO on days 1-28 of each cycle. Cycles repeat every 28 days for a total of 2 cycles, in the absence of disease progression or unacceptable toxicity. Patients also undergo bone marrow aspiration and collection of blood samples on study and as clinically indicated. |
|
|
Active Comparator ARM III (daunorubicin, cytarabine) |
Patients receive daunorubicin IV on days 1-3 and cytarabine IV, continuously, on days 1-7. Cycle is 28 days and treatment is given in the absence of disease progression or unacceptable toxicity. Based on a bone marrow aspiration assessment (completed at the discretion of the treating investigator), patients may receive reinduction consisting of cytarabine IV, continuously, on days 1-5 and daunorubicin IV on days 1-2. Cycle is 28 days and treatment is given in the absence of disease progression or unacceptable toxicity. Patients also undergo bone marrow aspiration and collection of blood samples on study and as clinically indicated. |
|
Recruiting Locations
University of Alabama at Birmingham Cancer Center
Birmingham, Alabama 35233
Birmingham, Alabama 35233
Banner University Medical Center - Tucson
Tucson, Arizona 85719
Tucson, Arizona 85719
University of Arizona Cancer Center-North Campus
Tucson, Arizona 85719
Tucson, Arizona 85719
University of Arkansas for Medical Sciences
Little Rock, Arkansas 72205
Little Rock, Arkansas 72205
Contact:
Site Public Contact
501-686-8274
Site Public Contact
501-686-8274
Cedars-Sinai Medical Center
Los Angeles, California 90048
Los Angeles, California 90048
UCSF Medical Center-Parnassus
San Francisco, California 94143
San Francisco, California 94143
Contact:
Site Public Contact
877-827-3222
Site Public Contact
877-827-3222
Miami Cancer Institute
Miami, Florida 33176
Miami, Florida 33176
Contact:
Site Public Contact
786-596-2000
Site Public Contact
786-596-2000
Memorial Hospital West
Pembroke Pines, Florida 33028
Pembroke Pines, Florida 33028
Contact:
Site Public Contact
954-265-4325
Site Public Contact
954-265-4325
Phoebe Putney Memorial Hospital
Albany, Georgia 31701
Albany, Georgia 31701
Saint Alphonsus Cancer Care Center-Boise
Boise, Idaho 83706
Boise, Idaho 83706
Saint Luke's Cancer Institute - Boise
Boise, Idaho 83712
Boise, Idaho 83712
Saint Alphonsus Cancer Care Center-Caldwell
Caldwell, Idaho 83605
Caldwell, Idaho 83605
Kootenai Health - Coeur d'Alene
Coeur d'Alene, Idaho 83814
Coeur d'Alene, Idaho 83814
Saint Luke's Cancer Institute - Fruitland
Fruitland, Idaho 83619
Fruitland, Idaho 83619
Saint Luke's Cancer Institute - Meridian
Meridian, Idaho 83642
Meridian, Idaho 83642
Saint Alphonsus Cancer Care Center-Nampa
Nampa, Idaho 83687
Nampa, Idaho 83687
Saint Luke's Cancer Institute - Nampa
Nampa, Idaho 83687
Nampa, Idaho 83687
Kootenai Clinic Cancer Services - Post Falls
Post Falls, Idaho 83854
Post Falls, Idaho 83854
Kootenai Clinic Cancer Services - Sandpoint
Sandpoint, Idaho 83864
Sandpoint, Idaho 83864
Centralia Oncology Clinic
Centralia, Illinois 62801
Centralia, Illinois 62801
Northwestern University
Chicago, Illinois 60611
Chicago, Illinois 60611
University of Chicago Comprehensive Cancer Center
Chicago, Illinois 60637
Chicago, Illinois 60637
Cancer Care Specialists of Illinois - Decatur
Decatur, Illinois 62526
Decatur, Illinois 62526
Decatur Memorial Hospital
Decatur, Illinois 62526
Decatur, Illinois 62526
Crossroads Cancer Center
Effingham, Illinois 62401
Effingham, Illinois 62401
NorthShore University HealthSystem-Evanston Hospital
Evanston, Illinois 60201
Evanston, Illinois 60201
Contact:
Site Public Contact
847-570-2109
Site Public Contact
847-570-2109
NorthShore University HealthSystem-Glenbrook Hospital
Glenview, Illinois 60026
Glenview, Illinois 60026
Contact:
Site Public Contact
847-570-2109
Site Public Contact
847-570-2109
NorthShore University HealthSystem-Highland Park Hospital
Highland Park, Illinois 60035
Highland Park, Illinois 60035
Contact:
Site Public Contact
847-570-2109
Site Public Contact
847-570-2109
Loyola University Medical Center
Maywood, Illinois 60153
Maywood, Illinois 60153
Contact:
Site Public Contact
708-226-4357
Site Public Contact
708-226-4357
UC Comprehensive Cancer Center at Silver Cross
New Lenox, Illinois 60451
New Lenox, Illinois 60451
Cancer Care Center of O'Fallon
O'Fallon, Illinois 62269
O'Fallon, Illinois 62269
University of Chicago Medicine-Orland Park
Orland Park, Illinois 60462
Orland Park, Illinois 60462
Southern Illinois University School of Medicine
Springfield, Illinois 62702
Springfield, Illinois 62702
Contact:
Site Public Contact
217-545-7929
Site Public Contact
217-545-7929
Springfield Clinic
Springfield, Illinois 62702
Springfield, Illinois 62702
Contact:
Site Public Contact
800-444-7541
Site Public Contact
800-444-7541
Springfield Memorial Hospital
Springfield, Illinois 62781
Springfield, Illinois 62781
UChicago Medicine Northwest Indiana
Crown Point, Indiana 46307
Crown Point, Indiana 46307
University of Iowa/Holden Comprehensive Cancer Center
Iowa City, Iowa 52242
Iowa City, Iowa 52242
Contact:
Site Public Contact
800-237-1225
Site Public Contact
800-237-1225
University of Kansas Clinical Research Center
Fairway, Kansas 66205
Fairway, Kansas 66205
University of Kansas Cancer Center
Kansas City, Kansas 66160
Kansas City, Kansas 66160
University of Kansas Hospital-Indian Creek Campus
Overland Park, Kansas 66211
Overland Park, Kansas 66211
University of Kansas Hospital-Westwood Cancer Center
Westwood, Kansas 66205
Westwood, Kansas 66205
University of Kentucky/Markey Cancer Center
Lexington, Kentucky 40536
Lexington, Kentucky 40536
Contact:
Site Public Contact
859-257-3379
Site Public Contact
859-257-3379
The James Graham Brown Cancer Center at University of Louisville
Louisville, Kentucky 40202
Louisville, Kentucky 40202
Contact:
Site Public Contact
502-562-3429
Site Public Contact
502-562-3429
UofL Health Medical Center Northeast
Louisville, Kentucky 40245
Louisville, Kentucky 40245
LSU Health Baton Rouge-North Clinic
Baton Rouge, Louisiana 70805
Baton Rouge, Louisiana 70805
Our Lady of the Lake Physician Group
Baton Rouge, Louisiana 70808
Baton Rouge, Louisiana 70808
Our Lady of The Lake
Baton Rouge, Louisiana 70808
Baton Rouge, Louisiana 70808
Contact:
Site Public Contact
225-765-7659
Site Public Contact
225-765-7659
MaineHealth Maine Medical Center - Portland
Portland, Maine 04102
Portland, Maine 04102
MaineHealth Maine Medical Center- Scarborough
Scarborough, Maine 04074
Scarborough, Maine 04074
MaineHealth Cancer Care and IV Therapy - South Portland
South Portland, Maine 04106
South Portland, Maine 04106
Walter Reed National Military Medical Center
Bethesda, Maryland 20889-5600
Bethesda, Maryland 20889-5600
Contact:
Site Public Contact
301-319-2100
Site Public Contact
301-319-2100
Tufts Medical Center
Boston, Massachusetts 02111
Boston, Massachusetts 02111
Dana-Farber Cancer Institute
Boston, Massachusetts 02215
Boston, Massachusetts 02215
Contact:
Site Public Contact
877-442-3324
Site Public Contact
877-442-3324
Lahey Clinic
Burlington, Massachusetts 01805
Burlington, Massachusetts 01805
Lahey Clinic Peabody
Peabody, Massachusetts 01960
Peabody, Massachusetts 01960
Trinity Health IHA Medical Group Hematology Oncology - Brighton
Brighton, Michigan 48114
Brighton, Michigan 48114
Trinity Health IHA Medical Group Hematology Oncology - Canton
Canton, Michigan 48188
Canton, Michigan 48188
Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital
Chelsea, Michigan 48118
Chelsea, Michigan 48118
Henry Ford Macomb Hospital-Clinton Township
Clinton Township, Michigan 48038
Clinton Township, Michigan 48038
Henry Ford Hospital
Detroit, Michigan 48202
Detroit, Michigan 48202
Cancer Hematology Centers - Flint
Flint, Michigan 48503
Flint, Michigan 48503
Genesys Hurley Cancer Institute
Flint, Michigan 48503
Flint, Michigan 48503
Hurley Medical Center
Flint, Michigan 48503
Flint, Michigan 48503
Allegiance Health
Jackson, Michigan 49201
Jackson, Michigan 49201
Trinity Health Saint Mary Mercy Livonia Hospital
Livonia, Michigan 48154
Livonia, Michigan 48154
Henry Ford Medical Center-Columbus
Novi, Michigan 48377
Novi, Michigan 48377
Trinity Health Saint Joseph Mercy Oakland Hospital
Pontiac, Michigan 48341
Pontiac, Michigan 48341
Henry Ford West Bloomfield Hospital
West Bloomfield, Michigan 48322
West Bloomfield, Michigan 48322
Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus
Ypsilanti, Michigan 48197
Ypsilanti, Michigan 48197
Mercy Hospital
Coon Rapids, Minnesota 55433
Coon Rapids, Minnesota 55433
Essentia Health - Deer River Clinic
Deer River, Minnesota 56636
Deer River, Minnesota 56636
Essentia Health Cancer Center
Duluth, Minnesota 55805
Duluth, Minnesota 55805
Fairview Southdale Hospital
Edina, Minnesota 55435
Edina, Minnesota 55435
Essentia Health Hibbing Clinic
Hibbing, Minnesota 55746
Hibbing, Minnesota 55746
Contact:
Site Public Contact
218-786-3308
Site Public Contact
218-786-3308
Abbott-Northwestern Hospital
Minneapolis, Minnesota 55407
Minneapolis, Minnesota 55407
Park Nicollet Clinic - Saint Louis Park
Saint Louis Park, Minnesota 55416
Saint Louis Park, Minnesota 55416
Regions Hospital
Saint Paul, Minnesota 55101
Saint Paul, Minnesota 55101
United Hospital
Saint Paul, Minnesota 55102
Saint Paul, Minnesota 55102
Essentia Health Sandstone
Sandstone, Minnesota 55072
Sandstone, Minnesota 55072
Essentia Health Virginia Clinic
Virginia, Minnesota 55792
Virginia, Minnesota 55792
Baptist Memorial Hospital and Cancer Center-Golden Triangle
Columbus, Mississippi 39705
Columbus, Mississippi 39705
Baptist Cancer Center-Grenada
Grenada, Mississippi 38901
Grenada, Mississippi 38901
Baptist Memorial Hospital and Cancer Center-Union County
New Albany, Mississippi 38652
New Albany, Mississippi 38652
Baptist Memorial Hospital and Cancer Center-Oxford
Oxford, Mississippi 38655
Oxford, Mississippi 38655
Baptist Memorial Hospital and Cancer Center-Desoto
Southhaven, Mississippi 38671
Southhaven, Mississippi 38671
Siteman Cancer Center at Saint Peters Hospital
City of Saint Peters, Missouri 63376
City of Saint Peters, Missouri 63376
Siteman Cancer Center at West County Hospital
Creve Coeur, Missouri 63141
Creve Coeur, Missouri 63141
Washington University School of Medicine
St Louis, Missouri 63110
St Louis, Missouri 63110
Siteman Cancer Center-South County
St Louis, Missouri 63129
St Louis, Missouri 63129
Siteman Cancer Center at Christian Hospital
St Louis, Missouri 63136
St Louis, Missouri 63136
Community Hospital of Anaconda
Anaconda, Montana 59711
Anaconda, Montana 59711
Billings Clinic Cancer Center
Billings, Montana 59101
Billings, Montana 59101
Bozeman Health Deaconess Hospital
Bozeman, Montana 59715
Bozeman, Montana 59715
Benefis Sletten Cancer Institute
Great Falls, Montana 59405
Great Falls, Montana 59405
Logan Health Medical Center
Kalispell, Montana 59901
Kalispell, Montana 59901
Community Medical Center
Missoula, Montana 59804
Missoula, Montana 59804
Nebraska Medicine-Bellevue
Bellevue, Nebraska 68123
Bellevue, Nebraska 68123
Nebraska Medicine-Village Pointe
Omaha, Nebraska 68118
Omaha, Nebraska 68118
Contact:
Site Public Contact
402-559-5600
Site Public Contact
402-559-5600
University of Nebraska Medical Center
Omaha, Nebraska 68198
Omaha, Nebraska 68198
OptumCare Cancer Care at Charleston
Las Vegas, Nevada 89102
Las Vegas, Nevada 89102
OptumCare Cancer Care at Fort Apache
Las Vegas, Nevada 89183
Las Vegas, Nevada 89183
Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center
Lebanon, New Hampshire 03756
Lebanon, New Hampshire 03756
Memorial Sloan Kettering Basking Ridge
Basking Ridge, New Jersey 07920
Basking Ridge, New Jersey 07920
Contact:
Site Public Contact
212-639-7592
Site Public Contact
212-639-7592
Saint Barnabas Medical Center
Livingston, New Jersey 07039
Livingston, New Jersey 07039
Monmouth Medical Center
Long Branch, New Jersey 07740
Long Branch, New Jersey 07740
Memorial Sloan Kettering Monmouth
Middletown, New Jersey 07748
Middletown, New Jersey 07748
Contact:
Site Public Contact
212-639-7592
Site Public Contact
212-639-7592
Memorial Sloan Kettering Bergen
Montvale, New Jersey 07645
Montvale, New Jersey 07645
Contact:
Site Public Contact
212-639-7592
Site Public Contact
212-639-7592
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey 08903
New Brunswick, New Jersey 08903
Contact:
Site Public Contact
732-235-7356
Site Public Contact
732-235-7356
The Valley Hospital - Luckow Pavilion
Paramus, New Jersey 07652
Paramus, New Jersey 07652
Valley Health System Ridgewood Campus
Ridgewood, New Jersey 07450
Ridgewood, New Jersey 07450
Community Medical Center
Toms River, New Jersey 08755
Toms River, New Jersey 08755
University of New Mexico Cancer Center
Albuquerque, New Mexico 87106
Albuquerque, New Mexico 87106
Roswell Park Cancer Institute
Buffalo, New York 14263
Buffalo, New York 14263
Memorial Sloan Kettering Commack
Commack, New York 11725
Commack, New York 11725
Contact:
Site Public Contact
212-639-7592
Site Public Contact
212-639-7592
Mount Sinai Hospital
New York, New York 10029
New York, New York 10029
Memorial Sloan Kettering Cancer Center
New York, New York 10065
New York, New York 10065
Contact:
Site Public Contact
212-639-7592
Site Public Contact
212-639-7592
University of Rochester
Rochester, New York 14642
Rochester, New York 14642
Contact:
Site Public Contact
585-275-5830
Site Public Contact
585-275-5830
Stony Brook University Medical Center
Stony Brook, New York 11794
Stony Brook, New York 11794
Contact:
Site Public Contact
800-862-2215
Site Public Contact
800-862-2215
Montefiore Medical Center - Moses Campus
The Bronx, New York 10467
The Bronx, New York 10467
Memorial Sloan Kettering Nassau
Uniondale, New York 11553
Uniondale, New York 11553
Contact:
Site Public Contact
212-639-7592
Site Public Contact
212-639-7592
Carolinas Medical Center/Levine Cancer Institute
Charlotte, North Carolina 28203
Charlotte, North Carolina 28203
Contact:
Site Public Contact
800-804-9376
Site Public Contact
800-804-9376
Novant Health Presbyterian Medical Center
Charlotte, North Carolina 28204
Charlotte, North Carolina 28204
Duke University Medical Center
Durham, North Carolina 27710
Durham, North Carolina 27710
Contact:
Site Public Contact
888-275-3853
Site Public Contact
888-275-3853
East Carolina University
Greenville, North Carolina 27834
Greenville, North Carolina 27834
Novant Health Forsyth Medical Center
Winston-Salem, North Carolina 27103
Winston-Salem, North Carolina 27103
Wake Forest University Health Sciences
Winston-Salem, North Carolina 27157
Winston-Salem, North Carolina 27157
Contact:
Site Public Contact
336-713-6771
Site Public Contact
336-713-6771
Case Western Reserve University
Cleveland, Ohio 44106
Cleveland, Ohio 44106
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma 73104
Oklahoma City, Oklahoma 73104
Saint Alphonsus Cancer Care Center-Ontario
Ontario, Oregon 97914
Ontario, Oregon 97914
Providence Portland Medical Center
Portland, Oregon 97213
Portland, Oregon 97213
Providence Saint Vincent Medical Center
Portland, Oregon 97225
Portland, Oregon 97225
Lehigh Valley Hospital-Cedar Crest
Allentown, Pennsylvania 18103
Allentown, Pennsylvania 18103
Geisinger Medical Center
Danville, Pennsylvania 17822
Danville, Pennsylvania 17822
Penn State Milton S Hershey Medical Center
Hershey, Pennsylvania 17033-0850
Hershey, Pennsylvania 17033-0850
Lewistown Hospital
Lewistown, Pennsylvania 17044
Lewistown, Pennsylvania 17044
University of Pittsburgh Cancer Institute (UPCI)
Pittsburgh, Pennsylvania 15232
Pittsburgh, Pennsylvania 15232
Contact:
Site Public Contact
412-647-8073
Site Public Contact
412-647-8073
Reading Hospital
West Reading, Pennsylvania 19611
West Reading, Pennsylvania 19611
Contact:
Site Public Contact
610-988-9323
Site Public Contact
610-988-9323
Geisinger Wyoming Valley/Henry Cancer Center
Wilkes-Barre, Pennsylvania 18711
Wilkes-Barre, Pennsylvania 18711
Prisma Health Cancer Institute - Spartanburg
Boiling Springs, South Carolina 29316
Boiling Springs, South Carolina 29316
Prisma Health Cancer Institute - Easley
Easley, South Carolina 29640
Easley, South Carolina 29640
Prisma Health Cancer Institute - Butternut
Greenville, South Carolina 29605
Greenville, South Carolina 29605
Prisma Health Cancer Institute - Faris
Greenville, South Carolina 29605
Greenville, South Carolina 29605
Prisma Health Cancer Institute - Eastside
Greenville, South Carolina 29615
Greenville, South Carolina 29615
Prisma Health Cancer Institute - Greer
Greer, South Carolina 29650
Greer, South Carolina 29650
Prisma Health Cancer Institute - Seneca
Seneca, South Carolina 29672
Seneca, South Carolina 29672
Baptist Memorial Hospital and Cancer Center-Collierville
Collierville, Tennessee 38017
Collierville, Tennessee 38017
Baptist Memorial Hospital and Cancer Center-Memphis
Memphis, Tennessee 38120
Memphis, Tennessee 38120
Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center
Houston, Texas 77030
Houston, Texas 77030
Ben Taub General Hospital
Houston, Texas 77030
Houston, Texas 77030
Contact:
Site Public Contact
713-873-2000
Site Public Contact
713-873-2000
Huntsman Cancer Institute/University of Utah
Salt Lake City, Utah 84112
Salt Lake City, Utah 84112
University of Vermont Medical Center
Burlington, Vermont 05401
Burlington, Vermont 05401
University of Vermont and State Agricultural College
Burlington, Vermont 05405
Burlington, Vermont 05405
University of Virginia Cancer Center
Charlottesville, Virginia 22908
Charlottesville, Virginia 22908
Inova Schar Cancer Institute
Fairfax, Virginia 22031
Fairfax, Virginia 22031
Inova Fairfax Hospital
Falls Church, Virginia 22042
Falls Church, Virginia 22042
Swedish Cancer Institute-Edmonds
Edmonds, Washington 98026
Edmonds, Washington 98026
Swedish Cancer Institute-Issaquah
Issaquah, Washington 98029
Issaquah, Washington 98029
Swedish Medical Center-First Hill
Seattle, Washington 98122
Seattle, Washington 98122
Duluth Clinic Ashland
Ashland, Wisconsin 54806
Ashland, Wisconsin 54806
Saint Vincent Hospital Cancer Center Green Bay
Green Bay, Wisconsin 54301
Green Bay, Wisconsin 54301
Saint Vincent Hospital Cancer Center at Saint Mary's
Green Bay, Wisconsin 54303
Green Bay, Wisconsin 54303
Gundersen Lutheran Medical Center
La Crosse, Wisconsin 54601
La Crosse, Wisconsin 54601
Medical College of Wisconsin
Milwaukee, Wisconsin 53226
Milwaukee, Wisconsin 53226
Contact:
Site Public Contact
414-805-3666
Site Public Contact
414-805-3666
Marshfield Medical Center-River Region at Stevens Point
Stevens Point, Wisconsin 54482
Stevens Point, Wisconsin 54482
Marshfield Medical Center - Weston
Weston, Wisconsin 54476
Weston, Wisconsin 54476
Centro Comprensivo de Cancer de UPR
San Juan, Puerto Rico 00927
San Juan, Puerto Rico 00927
San Juan City Hospital
San Juan, Puerto Rico 00936
San Juan, Puerto Rico 00936
Contact:
Site Public Contact
787-763-1296
Site Public Contact
787-763-1296
More Details
- NCT ID
- NCT05554393
- Status
- Recruiting
- Sponsor
- National Cancer Institute (NCI)
Detailed Description
PRIMARY OBJECTIVE: I. To compare the rates of undetectable measurable residual disease (MRD) in patients who achieve a complete remission (CR) after induction therapy with 7 +3 (cytarabine + daunorubicin hydrochloride [daunorubicin]) versus (vs.) azacitidine + venetoclax vs. 7+3 + venetoclax. SECONDARY OBJECTIVES: I. To estimate the frequency and severity of toxicities with each of the regimens. II. To estimate complete remission (CR) rates (with and without MRD), complete remission with incomplete count recovery (CRi) (with and without MRD) rates, event-free survival (EFS), relapse-free survival (RFS), and overall survival (OS) with each of the regimens. TERTIARY OBJECTIVES: I. To evaluate response to therapy received according to genomic findings. II. To evaluate MRD kinetics by following patients with detectable MRD through Tier 2 and beyond. III. To evaluate longer term outcomes by treatment arm, genomics, MRD outcome, and other features as patients receive additional myeloMATCH therapies to generate testable hypotheses for more precise patient selection for these therapies. OUTLINE: Patients are randomized to 1 of 3 arms. ARM I: Patients receive daunorubicin intravenously (IV) on days 2-4, cytarabine IV continuously on days 2-8, and venetoclax orally (PO) once per day (QD) on days 1-11. Cycle is 28 days and treatment is given in the absence of disease progression or unacceptable toxicity. Based on a bone marrow aspiration assessment (completed at the discretion of the treating investigator), patients may receive reinduction consisting of daunorubicin IV on days 2-3, cytarabine IV continuously on days 2-6, and venetoclax PO QD on days 1-8. Cycle is 28 days and treatment is given in the absence of disease progression or unacceptable toxicity. Patients also undergo bone marrow aspiration and collection of blood samples on study and as clinically indicated. ARM II: Patients receive azacitidine IV or subcutaneously (SC) on days 1-7 or days 1-5 and 8-9 and venetoclax PO on days 1-28 of each cycle. Cycles repeat every 28 days for a total of 2 cycles, in the absence of disease progression or unacceptable toxicity. Patients also undergo bone marrow aspiration and collection of blood samples on study and as clinically indicated. ARM III: Patients receive daunorubicin IV on days 1-3 and cytarabine IV, continuously, on days 1-7. Cycle is 28 days and treatment is given in the absence of disease progression or unacceptable toxicity. Based on a bone marrow aspiration assessment (completed at the discretion of the treating investigator), patients may receive reinduction consisting of cytarabine IV, continuously, on days 1-5 and daunorubicin IV on days 1-2. Cycle is 28 days and treatment is given in the absence of disease progression or unacceptable toxicity. Patients also undergo bone marrow aspiration and collection of blood samples on study and as clinically indicated. After completion of study treatment, patients are followed up at 4 weeks, every 3 months for 1 year every 6 months for the second year and yearly thereafter.