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Official Title
Randomized Phase III Study of Mosunetuzumab vs. Rituximab for Low Tumor Burden Follicular Lymphoma
Phase
Phase 3
Sponsor
National Cancer Institute (NCI)
Enrollment
600
Timeline
Oct 2024 → Mar 2032
About This Study
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.
Eligibility Criteria
Inclusion Criteria
- 1Participants 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.
- 2NOTE: 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.
- 3Participants 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)
- 4Participants must have low-tumor burden follicular lymphoma defined as:
- 5Nodal or extra-nodal tumor mass with diameter less than 7 cm in its greater diameter
- 6Involvement of no more than 3 nodal or extra nodal sites with diameter greater than 3 cm.
- 7Absence of B symptoms
- 8No symptomatic splenomegaly
- 9No compression syndrome (ureteral, orbital, gastrointestinal)
- 10No 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
- 11Participants must either be experiencing distress due to their disease or would prefer active management of their disease rather than a watch and wait approach
- 12Participants 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.
- 13NOTE: if the initial evaluation is insufficient to detect measurable disease, treating investigators may obtain a CT scan with contrast
- 14Participants must have bi-dimensionally measurable disease (at least one lesion with longest diameter \> 1.5 cm)
- 15Participants must not have had prior systemic therapy for follicular lymphoma. Radiation therapy for a previous diagnosis of early-stage follicular lymphoma is allowed
- 16Participant must be ≥ 18 years of age at the time of registration
- 17Participant must have Zubrod performance status of 0-2
- 18Participant must have a complete medical history and physical exam within 28 days prior to registration
- 19Leukocytes ≥ 3 x 10\^3/uL (within 28 days prior to registration)
- 20Hemoglobin \> 9.0 g/dL (within 28 days prior to registration)
- 21Absolute neutrophil count ≥ 1.5 x 10\^3/uL (within 28 days prior to registration)
- 22Platelets ≥ 100 x 10\^3/uL (within 28 days prior to registration)
- 23Total 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)
- 24Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) ≤ 3 × institutional ULN (within 28 days prior to registration)
- 25Lactate dehydrogenase (LDH) \< institutional ULN (within 28 days prior to registration)
- 26Participants 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
- 27Participants must not have an active or uncontrolled infection before initiation of study treatment in the opinion of the treating investigators
- 28Participants must not have uncontrolled diabetes within 14 days prior to registration in the opinion of the treating investigators
- 29Participants must not have uncontrolled blood pressure and hypertension within 14 days prior to registration in the opinion of the treating investigators
- 30Participants 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
- 31Participants 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
- 32Participants must not have active autoimmune disease requiring systemic therapy
- 33Participants must not have had undergone organ transplants requiring ongoing systemic immunosuppressive therapy
- 34Participants 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
- 35Participants must not have known chronic active Epstein Barr Virus infection (CAEBV); testing in asymptomatic participants is not required
- 36Participants must not have a positive test result for COVID-19 within seven (7) days prior to registration
- 37Participants 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
- 38Participants must not have a history of confirmed progressive multifocal leukoencephalopathy (PML)
- 39Participants must not have received allogeneic stem cell transplantation
- 40Participants must not have a history of macrophage activation syndrome (MAS) or hemophagocytic lymphohistiocytosis (HLH)
- 41Participants 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
- 42Participants 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
- 43Participants 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
- 44NOTE: 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.
- 45Participants must be informed of the investigational nature of this study and must sign and give informed consent in accordance with institutional and federal guidelines
- 46For 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
Locations
250 sites participating in this study
Emory University Hospital Midtown
Atlanta, Georgia 30308
Kristie A. Blum
Emory University Hospital/Winship Cancer Institute
Atlanta, Georgia 30322
Kristie A. Blum
Emory Saint Joseph's Hospital
Atlanta, Georgia 30342
Kristie A. Blum
Data sourced from ClinicalTrials.govView on ClinicalTrials.gov →