RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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).

Official Title

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)

Quick Facts

Study Start:2024-06-19
Study Completion:2029-11-20
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06356129

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.

Ages Eligible for Study:18 Years to 80 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * 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.
  2. * 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.
  3. * Must have Ann Arbor Stage II-IV disease.
  1. * Any significant medical condition, active infection, laboratory abnormality, or psychiatric illness that would prevent the participant from participating in the study.
  2. * 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.
  3. * Documented or suspected central nervous system (CNS) involvement by lymphoma.
  4. * Other protocol-defined Inclusion/Exclusion criteria apply.

Contacts and Locations

Study Contact

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
CONTACT
855-907-3286
Clinical.Trials@bms.com
First line of the email MUST contain the NCT# and Site #.
CONTACT

Principal Investigator

Bristol-Myers Squibb
STUDY_DIRECTOR
Bristol-Myers Squibb

Study Locations (Sites)

USA Mitchell Cancer Institute
Mobile, Alabama, 36604
United States
Alaska Oncology and Hematology
Anchorage, Alaska, 99508
United States
Mayo Clinic in Arizona - Phoenix
Phoenix, Arizona, 85054
United States
Local Institution - 0342
San Francisco, California, 94143
United States
Local Institution - 0497
Fort Myers, Florida, 33901
United States
Mayo Clinic in Florida
Jacksonville, Florida, 32224
United States
D&H Cancer Research Center LLC
Margate, Florida, 33063
United States
Local Institution - 0045
Miami Beach, Florida, 33140
United States
Sacred Heart Medical Oncology Group
Pensacola, Florida, 32504
United States
Local Institution - 0502
Saint Petersburg, Florida, 33705
United States
Local Institution - 0414
Tampa, Florida, 33612
United States
Local Institution - 0192
West Palm Beach, Florida, 33401
United States
Local Institution - 0485
Weston, Florida, 33331
United States
Local Institution - 0303
Atlanta, Georgia, 30322
United States
Local Institution - 0182
Chicago, Illinois, 60611
United States
Orchard Healthcare Research Inc.
Skokie, Illinois, 60077
United States
Mission Cancer + Blood
Des Moines, Iowa, 50309
United States
The University of Kansas Cancer Center - Westwood
Westwood, Kansas, 66205
United States
Local Institution - 0436
Edgewood, Kentucky, 41017
United States
Mary Bird Perkins Cancer Center Baton Rouge
Baton Rouge, Louisiana, 70809
United States
Local Institution - 0478
Ann Arbor, Michigan, 48109
United States
Allina Health Cancer Institute - Abbott Northwestern Hospital
Minneapolis, Minnesota, 55407
United States
Mayo Clinic in Rochester, Minnesota
Rochester, Minnesota, 55905
United States
Local Institution - 0437
Kansas City, Missouri, 64132
United States
Cancer Care Specialists
Reno, Nevada, 89511
United States
Local Institution - 0498
East Brunswick, New Jersey, 08816
United States
Local Institution - 0480
Hackensack, New Jersey, 07601
United States
Atlantic Health System Morristown Medical Center
Morristown, New Jersey, 07960
United States
Local Institution - 0175
New Brunswick, New Jersey, 08901
United States
Local Institution - 0190
Buffalo, New York, 14263
United States
Local Institution - 0451
East Syracuse, New York, 13057
United States
Local Institution - 0369
New York, New York, 10028
United States
Local Institution - 0176
New York, New York, 10029
United States
Local Institution - 0174
Chapel Hill, North Carolina, 27599
United States
Local Institution - 0066
Massillon, Ohio, 44646
United States
Oklahoma Cancer Specialists and Research Institute
Tulsa, Oklahoma, 74146
United States
Local Institution - 0179
Portland, Oregon, 97239
United States
UPMC Hillman Cancer Center
Pittsburgh, Pennsylvania, 15232
United States
WellSpan Oncology Research
York, Pennsylvania, 17403
United States
Local Institution - 0435
Fort Sam Houston, Texas, 78234
United States
Local Institution - 0424
Houston, Texas, 77030
United States
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
United States
Local Institution - 0293
Richmond, Virginia, 23298
United States
Local Institution - 0465
Tacoma, Washington, 98405
United States

Collaborators and Investigators

Sponsor: Celgene

  • Bristol-Myers Squibb, STUDY_DIRECTOR, Bristol-Myers Squibb

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-06-19
Study Completion Date2029-11-20

Study Record Updates

Study Start Date2024-06-19
Study Completion Date2029-11-20

Terms related to this study

Keywords Provided by Researchers

  • Lymphoma, Large B-Cell
  • Lymphoma
  • BMS-986369
  • CC-99282
  • DLBCL

Additional Relevant MeSH Terms

  • Large B-cell Lymphoma