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

Sponsor
The Lymphoma Academic Research Organisation
Study ID
NCT06271057
Phase
PHASE2
Status
Recruiting
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Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

First listed
Feb 21, 2024
Start date
Jun 14, 2024
Status verified
Jun 2026
Primary completion
Mar 31, 2027
Completion
Dec 31, 2028

Study Design

Enrollment
65 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: golcadomide post CAR T-cells
    0.3 mg - Per Os - every week - 6 months

Primary Outcome Measure

Complete metabolic response rate (CMR rate) [ Time Frame: 3 months ]

Central Contacts

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