Recruiting
Phase 3

Golcadomide & Rituximab

Sponsor:

Celgene

Code:

NCT06911502

Conditions

Follicular Lymphoma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Golcadomide

Rituximab

Lenalidomide

Cyclophosphamide

Doxorubicin

Study Details

Brief summary:

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.

Conditions

Follicular Lymphoma

Study ID

NCT06911502

Start date

Jul 28, 2025

Status verified date

May, 2026

Completion date

Jul 31, 2030

Anticipated

Primary completion date

Apr 24, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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: i) Relapsed FL is defined as relapse after an initial response of CR or PR to the most recent prior therapy.

ii) 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:

i) Absolute neutrophil count (ANC) ≥ 1,000 cells/mm3 (1.0 x 109 /L), ii) PLT count ≥ 75,000 cells/mm3 (75 x 109 /L) iii) 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), including history of prior large B-cell lymphomas (LBCL), 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

Enrollment

400 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Golcadomide + Rituximab

active comparator: Rituximab + Lenalidomide/Chemotherapy

Rituximab + Lenalidomide or R-CHOP (rituximab, cyclophosphamide, doxorubicin, vincristine and prednisone/prednisolone) or Rituximab + Bendamustine

Interventions

Golcadomide

Specified dose on specified days

Rituximab

Specified dose on specified days

Lenalidomide

Specified dose on specified days

Cyclophosphamide

Specified dose on specified days

Doxorubicin

Specified dose on specified days

Vincristine

Specified dose on specified days

Prednisone/Prednisolone

Specified dose on specified days

Bendamustine

Specified dose on specified days

Primary outcome measure

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

Central Contacts and Locations

Central contacts

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com

8559073286Clinical.Trials@bms.com

Locations

Infirmary Cancer Care

Recruiting

Mobile, Alabama, United States, 36607

Contacts

Furhan Yunus, Site 0014

901-634-5546

Alaska Oncology and Hematology

Recruiting

Anchorage, Alaska, United States, 99508

Contacts

Steven Liu, Site 0074

907-257-9851

City of Hope Comprehensive Cancer Center

Recruiting

Duarte, California, United States, 91010

Contacts

Alex Herrera, Site 0072

626-218-2405

UCSF Helen Diller Medical Center at Parnassus Heights

Recruiting

San Francisco, California, United States, 94143

Contacts

Charalambos Andreadis, Site 0119

415-238-1909

Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital

Recruiting

Marietta, Georgia, United States, 30060

Contacts

Dean Kirkel, Site 0021

770-281-5100

Southeastern Regional Medical Center

Recruiting

Newnan, Georgia, United States, 30265

Contacts

Sabarish Ayyappan, Site 0245

000-000-0000

Greater Baltimore Medical Center

Recruiting

Towson, Maryland, United States, 21204

Contacts

Zhuoyan Li, Site 0010

443-849-3051

Hattiesburg Clinic Hematology/Oncology

Recruiting

Hattiesburg, Mississippi, United States, 39401-7233

Contacts

John Hrom, Site 0013

601-261-1700

Texas Oncology - Central/South Texas

Recruiting

Austin, Texas, United States, 78705

Contacts

Jason Melear, Site 0237

512-427-9400

Texas Oncology - Northeast Texas

Recruiting

Tyler, Texas, United States, 75702

Contacts

Habte Yimer, Site 0236

903-579-9800

Hematology Oncology Associates of Fredericksburg

Recruiting

Fredericksburg, Virginia, United States, 22408

Contacts

Christopher Vaughn, Site 0030

540-371-0079

Blue Ridge Cancer Care

Recruiting

Roanoke, Virginia, United States, 24014

Contacts

Amanda Gillespie-Twardy, Site 0146

540-982-0237

Princess Margaret Cancer Centre

Recruiting

Toronto, Ontario, Canada, M5G 2M9

Contacts

Robert Kridel, Site 0035

41694645012243

More Information

Sponsor

Celgene

Last update posted

May 20, 2026

Last verified

May, 2026

Keywords

  • Follicular Lymphoma
  • Second Line Follicular Lymphoma
  • Third Line Follicular Lymphoma
  • Relapsed/refractory follicular lymphoma

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Celgene on 2026-05-20.