Clinical Trials Directory

Trials / Recruiting

RecruitingNCT06271057

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

Status
Recruiting
Phase
Phase 2
Study type
Interventional
Enrollment
65 (estimated)
Sponsor
The Lymphoma Academic Research Organisation · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

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

Timeline

Start date
2024-06-14
Primary completion
2026-01-15
Completion
2027-10-20
First posted
2024-02-21
Last updated
2024-10-15

Locations

13 sites across 1 country: France

Source: ClinicalTrials.gov record NCT06271057. Inclusion in this directory is not an endorsement.