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

NCT06271057 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 65

Last updated 2024-10-15

No results posted yet for this study

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

  • Diffuse Large B-cell Lymphoma Refractory
  • Refractory Primary Mediastinal Large B-Cell Lymphoma
  • Refractory Transformed B-cell Non-Hodgkin Lymphoma
  • Refractory High Grade B-Cell Lymphoma

Interventions

DRUG

golcadomide

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

Sponsors & Collaborators

  • Lymphoma Study Association

    collaborator OTHER

  • The Lymphoma Academic Research Organisation

    lead OTHER

Principal Investigators

  • Catherine THIEBLEMONT, Prof. Dr. · Hôpital Saint-Louis

  • Gabriel BRISOU, Prof. Dr. · Institut Paoli-Calmettes

  • François-Xavier GROS, Prof. Dr. · University Hospital, Bordeaux

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-06-14
Primary Completion
2026-01-15
Completion
2027-10-20

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06271057 on ClinicalTrials.gov