RecruitingPhase 2NCT05846750

Obinutuzumab in Combination With Lenalidomide in Relapsed or Refractory Marginal Zone Lymphoma

A Prospective, Open-label, Single-arm, Multicenter Study to Evaluate the Efficacy and Safety of Obinutuzumab(GA101) in Combination With Lenalidomide in Relapsed and Refractory(R/R) Marginal Zone Lymphoma (MZL)


Sponsor

Institute of Hematology & Blood Diseases Hospital, China

Enrollment

59 participants

Start Date

Nov 1, 2022

Study Type

INTERVENTIONAL

Conditions

Summary

This is a prospective, multicenter clinical study that will enroll 59 patients with relapsed and refractory (R/R) MZL. The study is designed to evaluate the efficacy and safety of the combination of obinutuzumab and lenalidomide in the treatment of relapsed and refractory marginal zone lymphoma (MZL).


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether a combination of two drugs — obinutuzumab (a targeted antibody) and lenalidomide (an immune-modulating drug) — can effectively treat marginal zone lymphoma (a type of slow-growing blood cancer) that has come back or stopped responding to previous treatment. **You may be eligible if...** - You are 18 or older - You have a confirmed diagnosis of marginal zone lymphoma - Your lymphoma has relapsed (come back) or is refractory (not responding to treatment) - You have received at least one prior treatment for your lymphoma - You are in reasonably good overall health **You may NOT be eligible if...** - You have had certain prior treatments including stem cell transplant within the last 6 months - You have serious heart, liver, or kidney problems - You are pregnant or breastfeeding - You have active infections including HIV or active hepatitis B/C - Your lymphoma has transformed into a more aggressive type 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

DRUGObinutuzumab

Induction (6 cycles, every 28 days/cycle): 1000 mg each time, administered on Days 1, 8, and 15 of Cycle 1, and on Day 1 of Cycles 2-6 ( 8 total infusions); Maintenance(12 cycles, every 2 months/cycle): 12 infusions of 1000 mg every 2 months for 2 years or until disease progression

DRUGlenalidomide

Induction( 6 cycles, every 28 days/cycle): 20 mg/day, oral, Dosing on Days 2-22, every 28 days/cycle of Cycles 1-6; Maintenance(12 cycles, every 28 days/cycle):10 mg on Days 2-22 of each 28-day cycle, 12 cycles for 1 year or until disease progression


Locations(1)

Institute of Hematology & Blood Diseases Hospital

Tianjin, Tian, China

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NCT05846750


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