Clinical Trial 23983

• Overview

  Study Title:

  Randomized Phase III Study of Mosunetuzumab vs. Rituximab for Low Tumor Burden Follicular Lymphoma

  Summary:

  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.

  Objective:

  Primary Objectives: 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. 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: To compare overall survival (OS) between participants randomized to rituximab versus mosunetuzumab. To compare overall response rates at the Week 40 assessment between participants randomized to rituximab versus mosunetuzumab. To compare event free survival (EFS) between participants randomized to rituximab versus mosunetuzumab. To compare the frequency and severity of toxicities between participants randomized to rituximab versus mosunetuzumab. To compare the restricted chance of longer PFS (2-6 years) between participants randomized to rituximab versus mosunetuzumab.

• Treatments

  Therapies:

  Bispecific monoclonal antibody; Chimeric monoclonal IgG1 kappa antibody; Monoclonal antibody-recombinent enzyme

  Medications:

  Mosunetuzumab (); Rituximab (); Rituximab Hyaluronidase ()

• Inclusion Criteria

  Key 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.
  • 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 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.
  • 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)
  • 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
  • Additional criteria will apply.

• Exclusion Criteria

  Key Exclusion Criteria:
  • Not meeting all of the inclusion criteria.

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