A Study to Compare the Efficacy and Safety of Golcadomide in Combination With Rituximab (Golca + R) vs Investigator's Choice in Participants With Relapsed/Refractory Follicular Lymphoma Who Have Received at Least 1 Prior Line of Systemic Therapy (GOLSEEK-4)

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
Celgene
Study ID
NCT06911502
Phase
PHASE3
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Golcadomide — DRUG
    Specified dose on specified days
  • Rituximab — DRUG
    Specified dose on specified days
  • Lenalidomide — DRUG
    Specified dose on specified days
  • Cyclophosphamide — DRUG
    Specified dose on specified days
  • Doxorubicin — DRUG
    Specified dose on specified days
  • Vincristine — DRUG
    Specified dose on specified days
  • Prednisone/Prednisolone — DRUG
    Specified dose on specified days
  • Bendamustine — DRUG
    Specified dose on specified days

Study Details

The study is designed as a multicenter, randomized, open label Phase 3 study to compare the efficacy and safety of golcadomide in combination with rituximab vs investigator's choice in participants with relapsed/refractory follicular lymphoma who have received at least one line of prior systemic therapy.

Key Dates

Start date
Jul 28, 2025
Status verified
May 2026
Primary completion
Apr 24, 2028
Completion
Jul 31, 2030

Study Design

Enrollment
400 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Golcadomide + Rituximab
  • Active Comparator: Rituximab + Lenalidomide/Chemotherapy
    Rituximab + Lenalidomide or R-CHOP (rituximab, cyclophosphamide, doxorubicin, vincristine and prednisone/prednisolone) or Rituximab + Bendamustine

Primary Outcome Measure

Progression free survival (PFS) assessed by Independent Review Adjudication committee (IRAC) [ Time Frame: Up to approximately 32 Months ]

Central Contacts

  • BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
    8559073286
    [email protected]
  • First line of the email MUST contain the NCT# and Site #.

Locations (31)

FacilityCityStateZIPSite coordinators
Local Institution - 0225BirminghamAlabama35205
Site 0225
Infirmary Cancer CareMobileAlabama36607
Furhan Yunus, Site 0014
901-634-5546
Alaska Oncology and HematologyAnchorageAlaska99508
Steven Liu, Site 0074
907-257-9851
Local Institution - 0215Little RockArkansas72205
Site 0215
City of Hope Comprehensive Cancer CenterDuarteCalifornia91010
Alex Herrera, Site 0072
626-218-2405
UCSF Helen Diller Medical Center at Parnassus HeightsSan FranciscoCalifornia94143
Charalambos Andreadis, Site 0119
415-238-1909
Local Institution - 0008JacksonvilleFlorida32256
Site 0008
Local Institution - 0214TampaFlorida33606
Site 0214
Local Institution - 0217TampaFlorida33612
Site 0217
Northwest Georgia Oncology Centers, a Service of Wellstar Cobb HospitalMariettaGeorgia30060
Dean Kirkel, Site 0021
770-281-5100
Southeastern Regional Medical CenterNewnanGeorgia30265
Sabarish Ayyappan, Site 0245
000-000-0000
Local Institution - 0240Arlington HeightsIllinois60005
Site 0240
Local Institution - 0253Iowa CityIowa52242
Site 0253
Local Institution - 0243WaukeeIowa50309
Site 0243
Local Institution - 0216WestwoodKansas66205
Site 0216
Local Institution - 0218LexingtonKentucky40536
Site 0218
Local Institution - 0023BaltimoreMaryland21201
Site 0023
Greater Baltimore Medical CenterTowsonMaryland21204
Zhuoyan Li, Site 0010
443-849-3051
Local Institution - 0145BostonMassachusetts02114
Site 0145
Local Institution - 0244BostonMassachusetts02215
Site 0244
Local Institution - 0247BostonMassachusetts02215
Site 0247
Hattiesburg Clinic Hematology/OncologyHattiesburgMississippi39401-7233
John Hrom, Site 0013
601-261-1700
Local Institution - 0144ProvidenceRhode Island02903
Site 0144
Texas Oncology - Central/South TexasAustinTexas78705
Jason Melear, Site 0237
512-427-9400
Local Institution - 0212Fort WorthTexas76104
Site 0212
Local Institution - 0230San AntonioTexas78240
Site 0230
Texas Oncology - Northeast TexasTylerTexas75702
Habte Yimer, Site 0236
903-579-9800
Local Institution - 0238FairfaxVirginia22304
Site 0238
Hematology Oncology Associates of FredericksburgFredericksburgVirginia22408
Christopher Vaughn, Site 0030
540-371-0079
Blue Ridge Cancer CareRoanokeVirginia24014
Amanda Gillespie-Twardy, Site 0146
540-982-0237
Local Institution - 0143VancouverWashington98684
Site 0143

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Local Institution - 0225· Birmingham, ALInfirmary Cancer Care· Mobile, ALAlaska Oncology and Hematology· Anchorage, AKLocal Institution - 0215· Little Rock, ARCity of Hope Comprehensive Cancer Center· Duarte, CAUCSF Helen Diller Medical Center at Parnassus Heights· San Francisco, CA

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