Comparing Rituximab and Mosunetuzumab Drug Treatments for People With Low Tumor Burden Follicular Lymphoma
Purpose
This phase III trial compares the effectiveness of rituximab to mosunetuzumab in treating patients with follicular lymphoma with a low tumor burden. Rituximab is a monoclonal antibody. It binds to a protein called CD20, which is found on B cells (a type of white blood cell) and some types of cancer cells. This may help the immune system kill cancer cells. Mosunetuzumab is a monoclonal antibody that may interfere with the ability of cancer cells to grow and spread. It is not yet known if giving rituximab or mosunetuzumab works better in treating patients with follicular lymphoma with a low tumor burden.
Conditions
- Classic Follicular Lymphoma
- Follicular Lymphoma With Unusual Cytological Features
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
Criteria
Inclusion Criteria:
- Participants must have a histologically confirmed diagnosis of classic follicular
lymphoma (cFL). cFL was previously categorized as grade 1-3A per World Health
Organization (WHO)-HAEM4R, but grading of classic follicular lymphoma (FL) is no
longer mandatory.
- NOTE: Participants with follicular lymphoma with uncommon features (uFL) are
eligible, including FL with diffuse growth pattern (dFL). Diagnosis is as per
local pathology. Lymphoma fluorescence in situ hybridization (FISH) is not
required. Molecular testing is not required.
- Participants must not have follicular lymphoma with "blastoid" or "large centrocyte"
cytological features, or follicular large B-cell lymphoma (FLBL) (previously
categorized as follicular lymphoma grade 3B)
- Participants must have low-tumor burden follicular lymphoma defined as:
- Nodal or extra-nodal tumor mass with diameter less than 7 cm in its greater
diameter
- Involvement of no more than 3 nodal or extra nodal sites with diameter greater
than 3 cm.
- Absence of B symptoms
- No symptomatic splenomegaly
- No compression syndrome (ureteral, orbital, gastrointestinal)
- No pleural or peritoneal serous effusion related to follicular lymphoma
Participants must have Ann Arbor stage II, III, or IV follicular lymphoma.
Participants with stage I disease may be included if they do not wish to
undergo radiation or are not candidates for radiation
- Participants must either be experiencing distress due to their disease or would
prefer active management of their disease rather than a watch and wait approach
- Participants must have staging imaging performed within 49 days prior to
registration, as follows. PET-CT baseline scans are preferred. If a baseline PET-CT
scan cannot be obtained, CT scans of the chest, abdomen, and pelvis, along with a
bone marrow biopsy, are acceptable. If CT scans are used for staging at baseline, a
CT scan of the neck is recommended. All measurable dominant lesions must be assessed
within 49 days prior to registration. Tests to assess non-measurable disease must be
performed within 49 days prior to registration. All disease must be assessed and
documented on the Baseline Tumor Assessment Form.
- NOTE: if the initial evaluation is insufficient to detect measurable disease,
treating investigators may obtain a CT scan with contrast
- Participants must have bi-dimensionally measurable disease (at least one lesion with
longest diameter > 1.5 cm)
- Participants must not have had prior systemic therapy for follicular lymphoma.
Radiation therapy for a previous diagnosis of early-stage follicular lymphoma is
allowed
- Participant must be ≥ 18 years of age at the time of registration
- Participant must have Zubrod performance status of 0-2
- Participant must have a complete medical history and physical exam within 28 days
prior to registration
- Leukocytes ≥ 3 x 10^3/uL (within 28 days prior to registration)
- Hemoglobin > 9.0 g/dL (within 28 days prior to registration)
- Absolute neutrophil count ≥ 1.5 x 10^3/uL (within 28 days prior to registration)
- Platelets ≥ 100 x 10^3/uL (within 28 days prior to registration)
- Total bilirubin ≤ 2 x institutional upper limit of normal (ULN) unless history of
Gilbert's disease. Participants with history of Gilbert's disease must have total
bilirubin ≤ 5 x institutional ULN (within 28 days prior to registration)
- Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) ≤ 3 × institutional
ULN (within 28 days prior to registration)
- Lactate dehydrogenase (LDH) < institutional ULN (within 28 days prior to
registration)
- Participants must have a calculated creatinine clearance ≥ 30 mL/min using the
following Cockcroft-Gault Formula. This specimen must have been collected and
processed within 28 days prior to registration
- Participants must not have an active or uncontrolled infection before initiation of
study treatment in the opinion of the treating investigators
- Participants must not have uncontrolled diabetes within 14 days prior to
registration in the opinion of the treating investigators
- Participants must not have uncontrolled blood pressure and hypertension within 14
days prior to registration in the opinion of the treating investigators
- Participants with known human immunodeficiency virus (HIV)-infection must be on
effective anti-retroviral therapy at registration and have undetectable viral load
test on the most recent test results obtained within 6 months prior to registration
- Participants with evidence of chronic hepatitis B virus (HBV) infection must have
undetectable HBV viral load while on suppressive therapy on the most recent test
results obtained within 6 months prior to registration, if indicated. Participants
with a positive total hepatitis (Hep) B core antibody and negative hepatitis B virus
surface antigen (HBsAg) at screening are at high risk for reactivation and should
receive prophylactic antivirals (e.g., entecavir) before and throughout the
treatment
- Participants must not have active autoimmune disease requiring systemic therapy
- Participants must not have had undergone organ transplants requiring ongoing
systemic immunosuppressive therapy
- Participants with a history of hepatitis C virus (HCV) infection must have been
treated and cured. Participants currently being treated for HCV infection must have
undetectable HCV viral load test on the most recent test results obtained within 6
months prior to registration, if indicated
- Participants must not have known chronic active Epstein Barr Virus infection
(CAEBV); testing in asymptomatic participants is not required
- Participants must not have a positive test result for COVID-19 within seven (7) days
prior to registration
- Participants must not have a prior or concurrent malignancy whose natural history or
treatment (in the opinion of the treating physician) has the potential to interfere
with the safety or efficacy assessment of the investigational regimen
- Participants must not have a history of confirmed progressive multifocal
leukoencephalopathy (PML)
- Participants must not have received allogeneic stem cell transplantation
- Participants must not have a history of macrophage activation syndrome (MAS) or
hemophagocytic lymphohistiocytosis (HLH)
- Participants with known history or current symptoms of cardiac disease, or history
of treatment with cardiotoxic agents, must have a clinical risk assessment of
cardiac function using the New York Heart Association Functional Classification.
Participant must not have significant cardiovascular disease such as class III or IV
cardiac disease, myocardial infarction within 6 months prior to registration.
Participants with unstable arrhythmias, or unstable angina, should be excluded
- Participants must not be pregnant or nursing (nursing includes breast milk fed to an
infant by any means, including from the breast, milk expressed by hand, or pumped).
Individuals who are of reproductive potential must have agreed to use an effective
contraceptive method with details provided as a part of the consent process. A
person who has had menses at any time in the preceding 12 consecutive months or who
has semen likely to contain sperm is considered to be of "reproductive potential."
In addition to routine contraceptive methods, "effective contraception" also
includes refraining from sexual activity that might result in pregnancy and surgery
intended to prevent pregnancy (or with a side-effect of pregnancy prevention)
including hysterectomy, bilateral oophorectomy, bilateral tubal ligation/occlusion,
and vasectomy with testing showing no sperm in the semen
- Participants must be offered the opportunity to participate in specimen banking.
With participant consent, specimens must be collected and submitted via the
Southwest Oncology Group (SWOG) Specimen Tracking System
- NOTE: As a part of the Oncology Patient Enrollment Network (OPEN) registration
process the treating institution's identity is provided in order to ensure that the
current (within 365 days) date of institutional review board approval for this study
has been entered in the system.
- Participants must be informed of the investigational nature of this study and
must sign and give informed consent in accordance with institutional and
federal guidelines
- For participants with impaired decision-making capabilities, legally authorized
representatives may sign and give informed consent on behalf of study
participants in accordance with applicable federal, local, and Central
Institutional Review Board (CIRB) regulations
Study Design
- Phase
- Phase 3
- 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 (Rituximab, rituximab and hyaluronidase) |
Patients receive rituximab IV on day 1 of cycle 1 and receive rituximab and hyaluronidase SC on days 8, 15 and 22 of cycle 1 and SC on day 1 of subsequent cycles. Cycles repeat every 56 days for up to 5 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo CT scan and/or PET/CT and blood sample collection on study and during follow up. |
|
|
Experimental Arm II (Mosunetuzumab) |
Patients receive mosunetuzumab SC on days 1, 8 and 15 of cycle 1 and on day 1 of subsequent cycles. Cycles repeat every 21 days for up to 8 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo CT scan and/or PET/CT and blood sample collection on study and during follow up. |
|
Recruiting Locations
Birmingham 4049979, Alabama 4829764 35233
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More Details
- NCT ID
- NCT06337318
- Status
- Recruiting
- Sponsor
- National Cancer Institute (NCI)
Detailed Description
PRIMARY OBJECTIVES: I. To compare the 3-year milestone progression free survival (PFS) probabilities in participants with previously untreated, low tumor burden follicular lymphoma randomized to the rituximab arm versus the mosunetuzumab arm. II. To compare progression free survival (PFS) in participants with previously untreated, low tumor burden follicular lymphoma randomized to the rituximab arm versus the mosunetuzumab arm. SECONDARY OBJECTIVES: I. To compare overall survival (OS) between participants randomized to rituximab versus mosunetuzumab. II. To compare overall response rates at the Week 40 assessment between participants randomized to rituximab versus mosunetuzumab. III. To compare event free survival (EFS) between participants randomized to rituximab versus mosunetuzumab. IV. To compare the frequency and severity of toxicities between participants randomized to rituximab versus mosunetuzumab. V. To compare the restricted chance of longer PFS (2-6 years) between participants randomized to rituximab versus mosunetuzumab. BANKING OBJECTIVE: I. To bank specimens for future correlative studies. OUTLINE: Patients are randomized to 1 of 2 arms. ARM I: Patients receive rituximab intravenously (IV) on day 1 of cycle 1 and receive rituximab and hyaluronidase subcutaneously (SC) on days 8, 15 and 22 of cycle 1 and SC on day 1 of subsequent cycles. Cycles repeat every 56 days for up to 5 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo computed tomography (CT) scan and/or positron emission tomography (PET)/CT and blood sample collection on study and during follow up. ARM II: Patients receive mosunetuzumab SC on days 1, 8 and 15 of cycle 1 and on day 1 of subsequent cycles. Cycles repeat every 21 days for up to 8 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo CT scan and/or PET/CT and blood sample collection on study and during follow up. After completion of study treatment, patients are followed up every 6 months for 5 years and then yearly for a total of 10 years.