RecruitingPhase 2NCT05552937

Evaluate the Safety and Efficacy of Tafasitamab Combined With Lenalidomide in Patients With Relapsed or Refractory DLBCL

A Phase II, Single-Arm, Open-Label, Multicentre Study to Evaluate the Safety and Efficacy of Tafasitamab Combined With Lenalidomide in Patients With Relapsed or Refractory Diffuse Large B-Cell Lymphoma


Sponsor

Beijing InnoCare Pharma Tech Co., Ltd.

Enrollment

50 participants

Start Date

Sep 6, 2021

Study Type

INTERVENTIONAL

Conditions

Summary

This is a A Phase II, Single-Arm, Open-Label, Multicentre Study to Evaluate the Safety and Efficacy of Tafasitamab Combined with Lenalidomide in Patients with Relapsed or Refractory Diffuse Large B-Cell Lymphoma


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing the combination of two drugs — tafasitamab (an antibody that targets cancer cells) and lenalidomide (an immune-modulating drug) — in people with diffuse large B-cell lymphoma (DLBCL) that has come back or stopped responding to prior treatment. **You may be eligible if...** - You are over 18 years old - You have confirmed DLBCL or a related large B-cell lymphoma that has relapsed or is refractory - You have received at least one prior line of therapy - You are not eligible for or have declined stem cell transplant - You have measurable disease and adequate organ function **You may NOT be eligible if...** - You have received prior tafasitamab or lenalidomide treatment - You have active or untreated brain involvement by lymphoma - You are pregnant or breastfeeding - You have significant heart, liver, or kidney dysfunction - You have an active serious infection or autoimmune condition 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

DRUGTafasitamab and Lenalidomide

Tafasitamab will be administered intravenously in 28-day cycles. During Cycles 1 through 3, tafasitamab will be administered weekly on Days 1, 8, 15, and 22; an additional loading dose will be administered on Cycle 1 Day 4. Starting with Cycle 4, tafasitamab will be administered on Days 1 and 15 of each cycle. Participants will self-administer lenalidomide capsules orally on Days 1-21 of each 28-day cycle, up to 12 cycles.


Locations(1)

The First Afflicated Hospital, College of Medicine, Zhejiang University

Hangzhou, Zhejiang, China

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NCT05552937


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