RecruitingPhase 2NCT06271057

Golcadomide Post-CAR T-cell in R/R Aggressive Large B-cell Lymphoma Patients With High Risk of Relapse

Golcadomide (BMS-986369) Post-CAR T-cell in R/R Aggressive Large B-cell Lymphoma Patients With High Risk of Relapse


Sponsor

The Lymphoma Academic Research Organisation

Enrollment

65 participants

Start Date

Jun 14, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

This study is an open-label, multicenter, proof of concept, phase 2 trial. Patients will be recruited over 18 months. Safety analysis will be performed with a stop of the enrollment after 3 patients have either 1 complete treatment cycle or permanently discontinued treatment whichever occurs first. Approximatively 65 patients with aggressive large B-cell lymphoma (LBCL) (including diffuse large B-cell lymphoma (DLBCL), Primary mediastinal B-cell lymphoma (PMBCL), any transformed follicular or marginal zone lymphoma, high-grade B-cell lymphoma (HGBL)) will be enrolled in the study. The duration of treatment with golcadomide (CELMoD) is 24 weeks with 6 cycles of 28 days (4 weeks), starting at 5 days after CAR-T cells infusion. The primary objective of the study is to estimate the efficacy of golcadomide administered post-anti-CD19 CAR T-cell infusion, Efficacy determination will be based upon the primary endpoint of complete metabolic response (CMR) rate at 3 months after infusion of anti-CD19 CAR T-cell assessed by study investigator.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a drug called golcadomide in people with aggressive large B-cell lymphoma (a type of blood cancer) who are at high risk of relapse after CAR T-cell therapy. CAR T-cell therapy reprograms your own immune cells to fight cancer. This study wants to know if golcadomide can prevent the cancer from coming back. **You may be eligible if...** - You are 18 or older - You have aggressive large B-cell lymphoma (such as diffuse large B-cell lymphoma) - You are eligible for commercially approved CAR T-cell therapy - You are in good general health (performance status 0 or 1) **You may NOT be eligible if...** - You have primary central nervous system lymphoma - You have significant organ function problems - You cannot tolerate the study drug based on prior allergies or conditions 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

DRUGgolcadomide

golcadomide 0.3 mg weekly from D+5 post CAR T-cells administration until D+166


Locations(13)

Hopital Henri Mondor

Créteil, France

Chu Dijon Bourgogne

Dijon, France

Chu de Grenoble

La Tronche, France

Chru de Lille

Lille, France

Institut Paoli Calmettes

Marseille, France

Chu de Montpellier

Montpellier, France

Chu de Nantes

Nantes, France

Hopital Saint-Louis

Paris, France

Chu de Bordeaux

Pessac, France

Chu Pontchaillou

Rennes, France

Centre Henri Becquerel

Rouen, France

Iuct Oncopole

Toulouse, France

Chu Brabois

Vandœuvre-lès-Nancy, France

View Full Details on ClinicalTrials.gov

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NCT06271057


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