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A Study to Evaluate Efficacy and Safety of Mosunetuzumab in Combination with Lenalidomide in Comparison to Rituximab in Combination with Lenalidomide in Patients with Follicular Lymphoma
EU CTIS ID: 2023-505807-21-00
What this study is testing
Arm A and Arm B: To evaluate the efficacy of mosunetuzumab in combination with lenalidomide (M+Len) compared with rituximab in combination with lenalidomide (R+Len) based on progression-free survival as determined by the independent review committee (IRC) Arm C: The primary efficacy objective for the non-randomized single arm extension is to evaluate the efficacy of M + Len based on Objective response rate (ORR) as determined by the independent review committee (IRC)
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Histologically documented CD20 + follicular lymphoma (FL) (Grades 1-3a)
- Requiring systemic therapy assessed by investigator based on tumor size and/or Groupe d'Etude des Lymphomes Folliculaires (GELF) criteria
- Received at least one prior systemic lymphoma therapy, which included prior immunotherapy or chemoimmunotherapy
- Availability of a representative tumor specimen and the corresponding pathology report at the time of relapse/persistence for confirmation of the diagnosis of FL
- Agreement to comply with all local requirements of the lenalidomide risk minimization plan, which includes the global pregnancy prevention program
- Adequate hematologic and organ function
You likely can't join if
- Any history of Grade 3b FL and transformation of indolent disease to diffuse large B-cell lymphoma (DLBCL or transformed FL)
- Known active bacterial, viral, fungal, or other infection, or any major episode of infection requiring treatment with IV antibiotics within 4 weeks of Day 1 of Cycle 1
- Documented refractoriness to lenalidomide, defined as no response within 6 months of therapy
- Positive SARS-CoV-2 test within 7 days prior to enrollment.
- Known or suspected history of central nervous system (CNS) lymphoma or leptomeningeal infiltration, HLH (hemophagocytic lymphohistiocytosis) and progressive multifocal leukoencephalopathy (PML)
- Evidence of any significant, uncontrolled concomitant disease that could affect compliance with the protocol or interpretation of results, including, but not limited to, significant cardiovascular disease or significant pulmonary disease
The study team makes the final eligibility decision.
Where it's taking place
- Brazil
- China
- Taiwan
- United States
- Russian Federation
- United Kingdom
- Korea, Republic of
- Turkey
- Australia
- Japan
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Brazil; China; Taiwan; United States; Russian Federation; United Kingdom and 4 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.