RecruitingPhase 3NCT04834024

MIL62 Combined With Lenalidomide Versus Lenalidomide for Patients With Rituximab Refractory Follicular Lymphoma

A Multi-center, Open Label, Phase III Study to Evaluate the Efficacy and Safety of MIL62 Plus Lenalidomide Versus Lenalidomide in Subjects With Follicular Lymphoma Refractory to Rituximab


Sponsor

Beijing Mabworks Biotech Co., Ltd.

Enrollment

168 participants

Start Date

Jun 2, 2021

Study Type

INTERVENTIONAL

Conditions

Summary

This phase III trial aims to compare the efficacy and safety of MIL62 combined lenalidomide and lenalidomide alone to treat patient diagnosed with Follicular Lymphoma (FL) and refractory to rituximab. The study randomized patients with a 1:1 ratio to receive either MIL62 plus lenalidomide or lenalidomide.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing whether a new antibody drug called MIL62 combined with lenalidomide (a standard immune-modulating drug) is better than lenalidomide alone for treating follicular lymphoma (a slow-growing blood cancer) that has stopped responding to rituximab, the usual first-line antibody treatment. **You may be eligible if...** - You are 18 years or older - You have follicular lymphoma (grade 1, 2, or 3a) confirmed by biopsy, with the CD20 protein on the cancer cells - Your lymphoma stopped responding to rituximab (rituximab-refractory) - Your cancer is measurable on scans - You are in reasonably good health and your blood counts and organs are adequate - Your expected survival is more than 5 years **You may NOT be eligible if...** - You have already tried lenalidomide and your cancer did not respond to it - Your lymphoma has spread to the brain or spinal fluid - You have progressive multifocal leukoencephalopathy (a serious brain infection) - You have received other antibody treatments (other than rituximab) for this cancer Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGRecombinant Humanized Monoclonal Antibody MIL62, lenalinomide

The patients confirming to the eligibility criteria will receive MIL62 from cycle 1 to cycle 30 and lenalidomide from cycle 1 to cycle 18, unless either rapid disease progression or unacceptable toxicity was observed.

DRUGlenalinomide

The patients confirming to the eligibility criteria will receive lenalidomide for 18 cycles, unless either rapid disease progression or unacceptable toxicity was observed.


Locations(1)

Chinese Academy of Medical Sciences and Peking Union Medical College

Beijing, China

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NCT04834024


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