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)

Purpose

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.

Condition

  • Follicular Lymphoma

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Participant has histologically confirmed FL (Grade 1, 2, 3a or classic FL) as assessed by local pathology. Adequate fresh tumor biopsy tissue or archived tumor biopsy from the latest relapse if available with corresponding pathology report for retrospective central pathology confirmation of relapse, is required. Evaluation from fine needle aspirate is not permitted. - Relapsed or refractory disease: 1. Relapsed FL is defined as relapse after an initial response of CR or PR to the most recent prior therapy. 2. Refractory FL is defined as best response of SD or PD or a response that lasted less than 6 months to the most recent prior therapy. - Eastern Cooperative Oncology Group (ECOG) 0-2 (ECOG 3 authorized if it is due to lymphoma and not comorbidities). - Participant must have positron emission tomography (PET)-positive disease with at least one PET-positive lesion and measurable disease on cross section imaging by CT, as defined by Lugano classification. - Participants with an indication for anti-lymphoma treatment as per investigator assessment based on modified Groupe d'Etude des Lymphomes Folliculaires (GELF) criteria. - Participant has received at least 1 or more prior lines of systemic therapy with one line consisting of a combination including an anti-CD20 monoclonal antibody (eg, rituximab, obinutuzumab) and an alkylating agent (eg, cyclophosphamide, bendamustine). Prior treatment with radiation therapy does not count as a line of therapy for eligibility. - Lab parameters: 1. Absolute neutrophil count (ANC) ≥ 1,000 cells/mm3 (1.0 x 109 /L), 2. PLT count ≥ 75,000 cells/mm3 (75 x 109 /L) 3. Hb ≥ 7.5 g/dL - estimated glomerular filtration rate (eGFR) ≥ 30 ml/min/1.73m². - Serum aspartate transaminase (AST/SGOT) or alanine transaminase (ALT/SGPT) ≤ 2.5 x upper limit of normal (ULN). In case of documented liver involvement by lymphoma, ALT/SGPT and AST/SGOT must be ≤ 5.0× ULN. - Serum total bilirubin ≤ 1.5 × ULN (corresponding to mild dysfunction as per National Cancer Institute Organ Dysfunction Working Group [NCI ODWG] criteria). In case of documented liver involvement by lymphoma, serum total bilirubin must be ≤ 3.0 × ULN (corresponding to moderate dysfunction as per NCI ODWG criteria). For cases of Gilberts syndrome, serum total bilirubin≤ 5.0 × ULN - Adequate cardiac function for participants receiving anthracycline-based chemotherapy, defined as left ventricular ejection fraction (LVEF) ≥ 45% as assessed by echocardiogram (ECHO) as standard of care or multi-gated acquisition scan (MUGA)

Exclusion Criteria

  • Evidence or history of composite Diffuse large B-cell lymphoma (DLBCL) and FL or of transformed Non-Hodgkin Lymphoma (NHL) or any other indolent lymphoma. - Follicular large cell as per 5th World Health Organization (WHO) sub-classification (grade 3b FL per WHO 4th classification) or duodenal-type FL. - Participant has any significant medical condition, laboratory abnormality, or psychiatric illness that would prevent the participant from compliantly participating in the study based on Investigator's judgment. - Participant has any condition that confounds the ability to interpret data from the study based on Investigator's or Sponsor's judgment. - Presence or history of central nervous system (CNS) involvement by lymphoma. - History of stroke or intracranial hemorrhage within 6 months prior to enrollment. - Deep venous thrombosis/Pulmonary embolism within 1 month prior to enrollment. - Participants with a history of progressive multifocal leukoencephalopathy. - Participant has any other subtype of lymphoma. - Participant has persistent diarrhea or malabsorption ≥ Grade 2 (NCI CTCAE v5.0), despite medical management. - History of another primary malignancy that has not been in remission for ≥ 3 years except for non-invasive malignancies. - Other protocol-defined Inclusion/Exclusion criteria apply.

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Golcadomide + Rituximab
  • Drug: Golcadomide
    Specified dose on specified days
    Other names:
    • CC-99282
    • BMS-986369
  • Drug: Rituximab
    Specified dose on specified days
Active Comparator
Rituximab + Lenalidomide/Chemotherapy 		Rituximab + Lenalidomide or R-CHOP (rituximab, cyclophosphamide, doxorubicin, vincristine and prednisone/prednisolone) or Rituximab + Bendamustine
  • Drug: Rituximab
    Specified dose on specified days
  • Drug: Lenalidomide
    Specified dose on specified days
  • Drug: Cyclophosphamide
    Specified dose on specified days
  • Drug: Doxorubicin
    Specified dose on specified days
  • Drug: Vincristine
    Specified dose on specified days
  • Drug: Prednisone/Prednisolone
    Specified dose on specified days
  • Drug: Bendamustine
    Specified dose on specified days

Recruiting Locations

Infirmary Cancer Care
Mobile 4076598, Alabama 4829764 36607
Contact:
Furhan Yunus, Site 0014
901-634-5546

Alaska Oncology and Hematology
Anchorage 5879400, Alaska 5879092 99508
Contact:
Steven Liu, Site 0074
907-257-9851

City of Hope Comprehensive Cancer Center
Duarte 5344147, California 5332921 91010
Contact:
Alex Herrera, Site 0072
626-218-2405

UCSF Helen Diller Medical Center at Parnassus Heights
San Francisco 5391959, California 5332921 94143
Contact:
Charalambos Andreadis, Site 0119
415-238-1909

Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital
Marietta 4207783, Georgia 4197000 30060
Contact:
Dean Kirkel, Site 0021
770-281-5100

Southeastern Regional Medical Center
Newnan 4212684, Georgia 4197000 30265
Contact:
Sabarish Ayyappan, Site 0245
000-000-0000

Greater Baltimore Medical Center
Towson 4371582, Maryland 4361885 21204
Contact:
Zhuoyan Li, Site 0010
443-849-3051

Hattiesburg Clinic Hematology/Oncology
Hattiesburg 4429295, Mississippi 4436296 39401-7233
Contact:
John Hrom, Site 0013
601-261-1700

Texas Oncology - Central/South Texas
Austin 4671654, Texas 4736286 78705
Contact:
Jason Melear, Site 0237
512-427-9400

Texas Oncology - Northeast Texas
Tyler 4738214, Texas 4736286 75702
Contact:
Habte Yimer, Site 0236
903-579-9800

Hematology Oncology Associates of Fredericksburg
Fredericksburg 4760059, Virginia 6254928 22408
Contact:
Christopher Vaughn, Site 0030
540-371-0079

Blue Ridge Cancer Care
Roanoke 4782167, Virginia 6254928 24014
Contact:
Amanda Gillespie-Twardy, Site 0146
540-982-0237

More Details

Status
Recruiting
Sponsor
Celgene

Study Contact

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
8559073286
Clinical.Trials@bms.com