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Clinical Trials in India / NCT06356129
Active, not recruiting Phase 3

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 · tracked via the Priya Life Science India tracker
Sponsor
Celgene
Phase
Phase 3
Started
2024-06-19
Last updated
2026-07-06

Condition(s) studied

Large B-cell Lymphoma

Investigational drug(s) / intervention(s)

GolcadomidePlaceboRituximabCyclophosphamideDoxorubicinVincristinePrednisone

Golcadomide: Specified dose on specified days

Placebo: Specified dose on specified days

Rituximab: Specified dose on specified days

Cyclophosphamide: Specified dose on specified days

Doxorubicin: Specified dose on specified days

Vincristine: Specified dose on specified days

Prednisone: Specified dose on specified days

Study summary

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).

Eligibility

Sex
ALL
Min age
18 Years
Max age
80 Years
Healthy volunteers
No
Inclusion Criteria \- Histologically confirmed (per local evaluation) diagnosis of de novo, previously untreated large B-cell lymphoma (LBCL) according to 2022 world health organization (WHO) classification including: i) Diffuse large B-cell lymphoma (DLBCL), not otherwise specified \[including germinal center B-cell (GCB) and activated B-cell (ABC) types\] ii) High-grade B-cell lymphoma, with MYC and BCL2 rearrangements (HGBL-MYC/BCL2 double-hit lymphomas) iii) High-grade B-cell lymphoma, not otherwise specified iv) T-cell/histiocyte/rich large B-cell lymphoma (THRLBCL) v) Epstein-Barr virus + DLBCL * International Prognostic Index (IPI) score 1 or 2 with lactate dehydrogenase (LDH) \> 1.3 x upper limit of normal (ULN) and/or bulky disease defined as single lesion of ≥ 7 cm OR IPI ≥ 3. * Measurable disease defined by at least 1 fluorodeoxyglucose (FDG)-avid lesion for FDG-avid subtype and 1 bi-dimensionally measurable (\> 1.5 cm in longest diameter) disease by computed tomography (CT) or magnetic resonance imaging (MRI), as defined by the Lugano classification. * Must have Ann Arbor Stage II-IV disease. Exclusion Criteria * Any significant medical condition, active infection, laboratory abnormality, or psychiatric illness that would prevent the participant from participating in the study. * Any other subtype of lymphoma. Cases of primary mediastinal (thymic) large B-cell lymphoma (PMBCL), primary cutaneous DLBCL-leg type, Grade 3b FL, indolent lymphoma transformed to large B-cell lymphoma (LBCL), Anaplastic lymphoma kinase (ALK) positive large B-cell lymphoma, primary effusion lymphoma, and Burkitt lymphoma. * Documented or suspected central nervous system (CNS) involvement by lymphoma. * Other protocol-defined Inclusion/Exclusion criteria apply.

Primary outcome measure(s)

Trial sites (325)

FacilityCityRegionStatus
Local Institution - 0014 Mobile Alabama
Local Institution - 0477 Anchorage Alaska
Local Institution - 0452 Phoenix Arizona
Local Institution - 0342 San Francisco California
Local Institution - 0497 Fort Myers Florida
Local Institution - 0287 Jacksonville Florida
Local Institution - 0415 Margate Florida
Local Institution - 0045 Miami Beach Florida
Local Institution - 0012 Pensacola Florida
Local Institution - 0502 St. Petersburg Florida
Local Institution - 0414 Tampa Florida
Local Institution - 0192 West Palm Beach Florida
Local Institution - 0485 Weston Florida
Local Institution - 0515 Atlanta Georgia
Local Institution - 0303 Atlanta Georgia
Local Institution - 0182 Chicago Illinois
Local Institution - 0048 Skokie Illinois
Local Institution - 0461 Waukee Iowa
Local Institution - 0031 Westwood Kansas
Local Institution - 0436 Edgewood Kentucky
Local Institution - 0408 Baton Rouge Louisiana
Local Institution - 0478 Ann Arbor Michigan
Local Institution - 0067 Minneapolis Minnesota
Local Institution - 0203 Rochester Minnesota
Local Institution - 0437 Kansas City Missouri
Local Institution - 0466 Reno Nevada
Local Institution - 0498 East Brunswick New Jersey
Local Institution - 0480 Hackensack New Jersey
Local Institution - 0049 Morristown New Jersey
Local Institution - 0175 New Brunswick New Jersey
Local Institution - 0190 Buffalo New York
Local Institution - 0451 East Syracuse New York
Local Institution - 0484 New York New York
Local Institution - 0369 New York New York
Local Institution - 0176 New York New York
Local Institution - 0174 Chapel Hill North Carolina
Local Institution - 0066 Massillon Ohio
Local Institution - 0450 Tulsa Oklahoma
Local Institution - 0179 Portland Oregon
Local Institution - 0009 Pittsburgh Pennsylvania

+ 285 more sites — see the full list on the official registry below.

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06356129 on ClinicalTrials.gov ↗ ← All trials in India