Ignite Creation Date:
2024-05-06 @ 8:09 PM
Last Modification Date:
2024-10-26 @ 3:21 PM
Study NCT ID:
NCT06271057
Status:
RECRUITING
Last Update Posted:
2024-02-21
First Post:
2024-02-14
Brief Title:
Golcadomide Post-CAR T-cell in RR Aggressive Large B-cell Lymphoma Patients With High Risk of Relapse
Sponsor:
The Lymphoma Academic Research Organisation
Organization:
The Lymphoma Academic Research Organisation
Study Overview
Official Title:
Golcadomide BMS-986369 Post-CAR T-cell in RR Aggressive Large B-cell Lymphoma Patients With High Risk of Relapse
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None