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

Phase 3

Recruiting

• Conditions: Large B-cell Lymphoma
• Interventions: Drug: Golcadomide; Drug: Placebo; Drug: Rituximab; Drug: Cyclophosphamide; Drug: Doxorubicin; Drug: Vincristine; Drug: Prednisone

• Registration Number: NCT06356129
• Lead Sponsor: Celgene

Brief 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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-03-27
• Study First Submitted QC: 2024-04-08
• Study First Posted: 2024-04-10
• Study Start: 2024-06-19
• Status Verified: 2025-07
• Last Update Submitted: 2025-07-08
• Last Update Posted: 2025-07-09
• Primary Completion: 2028-08-14
• Study Completion: 2029-11-20

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 850

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Golcadomide + R-CHOP (Rituximab, Doxorubicin, Vincristine, Cyclophosphamide, Prednisone)	Golcadomide	-
Golcadomide + R-CHOP (Rituximab, Doxorubicin, Vincristine, Cyclophosphamide, Prednisone)	Rituximab	-
Golcadomide + R-CHOP (Rituximab, Doxorubicin, Vincristine, Cyclophosphamide, Prednisone)	Cyclophosphamide	-
Golcadomide + R-CHOP (Rituximab, Doxorubicin, Vincristine, Cyclophosphamide, Prednisone)	Doxorubicin	-
Golcadomide + R-CHOP (Rituximab, Doxorubicin, Vincristine, Cyclophosphamide, Prednisone)	Vincristine	-
Golcadomide + R-CHOP (Rituximab, Doxorubicin, Vincristine, Cyclophosphamide, Prednisone)	Prednisone	-
Placebo + R-CHOP	Cyclophosphamide	-
Placebo + R-CHOP	Doxorubicin	-
Placebo + R-CHOP	Placebo	-
Placebo + R-CHOP	Rituximab	-
Placebo + R-CHOP	Vincristine	-
Placebo + R-CHOP	Prednisone	-

Primary Outcome Measures

Name	Time	Method
Progression-free survival (PFS) assessed by the Investigator	Up to approximately 67 months

Secondary Outcome Measures

Name	Time	Method
Overall survival (OS)	Up to approximately 67 months
Second progression-free survival (PFS2) assessed by the Investigator	Up to approximately 67 months
PFS assessed by the Investigator	Up to approximately 67 months
Event-free survival (EFS)	Up to approximately 67 months
Complete Metabolic Response assessed by the Independent Response Adjudication Committee (IRAC)	Up to approximately 18 weeks
Minimal residual disease (MRD) negativity rate	Up to approximately 18 weeks
Progression-free survival (PFS) assessed by the IRAC	Up to approximately 47 months
Objective response (OR) assessed by the Investigator	Up to approximately 18 weeks
Complete metabolic response (CMR) assessed by the Investigator	Up to approximately 18 weeks
PFS24 assessed by the Investigator 24 months after randomization	Up to 24 months
Duration of response (DoR)	Up to approximately 67 months
Relative dose intensity (%)	Up to 18 weeks
Number of participants with Adverse Events (AEs)	Up to approximately 20 weeks
Mean change from baseline in the EORTC QLQ-C30	Up to approximately 67 months
Mean change from baseline in the FACT-LymS	Up to approximately 67 months
Number of participants with treatment-emergent adverse events (TEAEs)	Up to approximately 20 weeks
Number of participants with laboratory abnormalities	Up to approximately 20 weeks
Number of participants with vital sign abnormalities	Up to approximately 20 weeks
Time from randomization to meaningful improvement in primary domains of interest in the European Organization for Research and Treatment of Cancer - Quality of Life C30 (EORTC QLQ-C30) Questionnaire	Up to approximately 67 months
Time from randomization to meaningful improvement in primary domains of interest in the Functional Assessment of Cancer Treatment-Lymphoma (FACT-LymS) Questionnaire	Up to approximately 67 months

Trial Locations

Locations (343)

USA Mitchell Cancer Institute; 🇺🇸 Mobile, Alabama, United States

Alaska Oncology and Hematology; 🇺🇸 Anchorage, Alaska, United States

Mayo Clinic in Arizona - Phoenix; 🇺🇸 Phoenix, Arizona, United States

Local Institution - 0342; 🇺🇸 San Francisco, California, United States

Florida Cancer Specialists - South; 🇺🇸 Fort Myers, Florida, United States

Mayo Clinic in Florida; 🇺🇸 Jacksonville, Florida, United States

D&H Cancer Research Center LLC; 🇺🇸 Margate, Florida, United States

Mount Sinai Cancer Center; 🇺🇸 Miami Beach, Florida, United States

Sacred Heart Medical Oncology Group; 🇺🇸 Pensacola, Florida, United States

Florida Cancer Specialists - North; 🇺🇸 Saint Petersburg, Florida, United States

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