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

Description

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).

Conditions

Large B-cell Lymphoma

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Study Overview

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Study Details

Study overview

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).

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)

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

Condition
Large B-cell Lymphoma
Intervention / Treatment

-

Contacts and Locations

Mobile

USA Mitchell Cancer Institute, Mobile, Alabama, United States, 36604

Anchorage

Alaska Oncology and Hematology, Anchorage, Alaska, United States, 99508

Phoenix

Mayo Clinic in Arizona - Phoenix, Phoenix, Arizona, United States, 85054

San Francisco

Local Institution - 0342, San Francisco, California, United States, 94143

Fort Myers

Local Institution - 0497, Fort Myers, Florida, United States, 33901

Jacksonville

Mayo Clinic in Florida, Jacksonville, Florida, United States, 32224

Margate

D&H Cancer Research Center LLC, Margate, Florida, United States, 33063

Miami Beach

Local Institution - 0045, Miami Beach, Florida, United States, 33140

Pensacola

Sacred Heart Medical Oncology Group, Pensacola, Florida, United States, 32504

Saint Petersburg

Local Institution - 0502, Saint Petersburg, Florida, United States, 33705

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * 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.
  • * 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.

Ages Eligible for Study

18 Years to 80 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Celgene,

Bristol-Myers Squibb, STUDY_DIRECTOR, Bristol-Myers Squibb

Study Record Dates

2029-11-20