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Golcadomide

Placebo

BMS Study Connect Contact Center www.BMSStudyConnect.com

First line of the email MUST contain NCT # and Site #.

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Bristol-Myers Squibb

The purpose of this study is to compare the effectiveness and safety of golcadomide in combination with rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP) chemotherapy vs placebo in combination with R-CHOP chemotherapy in participants with previously untreated high-risk large B-cell lymphoma (LBCL).

Study to Compare the Effectiveness and Safety of Golcadomide Plus R-CHOP vs Placebo Plus R-CHOP in Participants With Previously Untreated High-risk Large B-cell Lymphoma

A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Study Comparing the Efficacy and Safety of Golcadomide Plus R-CHOP Chemotherapy vs Placebo Plus R-CHOP Chemotherapy in Participants With Previously Untreated High-risk Large B-cell Lymphoma (GOLSEEK-1)

BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria.

Additional information regarding Bristol Myer Squibb's data sharing policy and process can be found at:

https://www.bms.com/researchers-and-partners/clinical-trials-and-research/disclosurecommitment.html

Celgene

Behaviors and Mental Disorders

Lymphoma, Large B-Cell, Diffuse

Aggression

Diffuse Large B-Cell Lymphoma

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

golcadomide

Stéphanie DOYEN

Catherine THIEBLEMONT, Prof. Dr.

Gabriel BRISOU, Prof. Dr.

François-Xavier GROS, Prof. Dr.

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.

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

efficacy of golcadomide administered post-anti-CD19 CAR T-cell infusion

incidence of either a complete (CMR) or a partial (PMR) metabolic response per the Lugano Classification (Cheson 2014) as determined by study investigators

percentage of complete response determined by investigator assessment classification

time from attainment of PMR or CMR to the date of first documented disease progression/relapse (based on investigator disease assessment (INV)) or death from any cause

the time between CAR T-cells injection and death, disease progression, or start of subsequent new anti-lymphoma therapy including Stem Cell Transplant (SCT)

time from CAR T-cells injection to the first observation of documented disease progression/relapse (based on investigator disease assessment (INV)) or death

from the date of CAR T-cells injection to the date of first documented administration of any new anti-lymphoma treatment

from date of CAR T-cells injection to the date of death

Lymphoma Study Association

The Lymphoma Academic Research Organisation

Lymphoma, Follicular

Follicular Lymphoma

Bendamustine Hydrochloride

R-CHOP (Rituximab, Doxorubicin, Vincristine, Cyclophosphamide, Prednisone) or Rituximab + Bendamustine

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Study to Compare the Effectiveness and Safety of Golcadomide Plus R-CHOP vs Placebo Plus R-CHOP in Participants With Previously Untreated High-risk Large B-cell Lymphoma	NCT06356129	Large B-cell Ly...	Golcadomide Placebo Rituximab Cyclophosphamid... Doxorubicin Vincristine Prednisone	18 Years - 80 Years	Celgene
Golcadomide Post-CAR T-cell in R/R Aggressive Large B-cell Lymphoma Patients With High Risk of Relapse	NCT06271057	Diffuse Large B... Refractory Prim... Refractory Tran... Refractory High...	golcadomide	18 Years -	The Lymphoma Academic Research Organisation
Golcadomide Post-CAR T-cell in R/R Aggressive Large B-cell Lymphoma Patients With High Risk of Relapse	NCT06271057	Diffuse Large B... Refractory Prim... Refractory Tran... Refractory High...	golcadomide	18 Years -	The Lymphoma Academic Research Organisation
A Study to Evaluate the Efficacy and Safety of Golcadomide in Combination With Rituximab in Participants With Newly Diagnosed Advanced Stage Follicular Lymphoma	NCT06425302	Lymphoma, Folli...	Golcadomide Rituximab Cyclophosphamid... Doxorubicin Vincristine Prednisone Bendamustine	18 Years -	Celgene
Study to Compare the Effectiveness and Safety of Golcadomide Plus R-CHOP vs Placebo Plus R-CHOP in Participants With Previously Untreated High-risk Large B-cell Lymphoma	NCT06356129	Large B-cell Ly...	Golcadomide Placebo Rituximab Cyclophosphamid... Doxorubicin Vincristine Prednisone	18 Years - 80 Years	Celgene
Study to Compare the Effectiveness and Safety of Golcadomide Plus R-CHOP vs Placebo Plus R-CHOP in Participants With Previously Untreated High-risk Large B-cell Lymphoma	NCT06356129	Large B-cell Ly...	Golcadomide Placebo Rituximab Cyclophosphamid... Doxorubicin Vincristine Prednisone	18 Years - 80 Years	Celgene

Spots Global Cancer Trial Database for golcadomide

Every month we try and update this database with for golcadomide cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for golcadomide

Every month we try and update this database with for golcadomide cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for golcadomide cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.