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RecruitingInterventionalPhase 3

A Phase 3, Multicenter, Randomized, Open Label 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

NCT ID: NCT06911502Sponsor: CelgeneLast updated: 2026-05-20

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.

Arms & interventions

  • DrugGolcadomide

    Specified dose on specified days

  • DrugRituximab

    Specified dose on specified days

  • DrugLenalidomide

    Specified dose on specified days

  • DrugCyclophosphamide

    Specified dose on specified days

  • DrugDoxorubicin

    Specified dose on specified days

  • DrugVincristine

    Specified dose on specified days

  • DrugPrednisone/Prednisolone

    Specified dose on specified days

  • DrugBendamustine

    Specified dose on specified days

Outcome measures

Primary

  • Progression free survival (PFS) assessed by Independent Review Adjudication committee (IRAC)

    Time frame: Up to approximately 32 Months

Secondary

  • Overall response rate (ORR) assessed by IRAC

    Time frame: Up to approximately 32 Months

  • Overall survival (OS)

    Time frame: Up to approximately 83 Months

  • PFS as assessed by investigator

    Time frame: Up to approximately 32 Months

  • ORR as assessed by investigator

    Time frame: Up to approximately 32 Months

  • Number of participants who achieve complete metabolic response (CMR)

    Time frame: Up to approximately 32 Months

  • Duration of Response (DoR)

    Time frame: Up to approximately 32 Months

  • Event free survival (EFS)

    Time frame: Up to approximately 32 Months

  • Time to next anti-lymphoma treatment (TTNT)

    Time frame: Up to approximately 32 Months

  • PFS on next anti-lymphoma treatment (PFS2)

    Time frame: Up to approximately 32 Months

  • Time from randomization to meaningful improvement in primary domains of interest in the European Organization for Research and Treatment of Cancer - Quality of Life C30 (EORTC QLQ-C30) Questionnaire

    Time frame: Up to approximately 32 Months

  • Time from randomization to meaningful improvement in primary domains of interest in the European Organization for Research and Treatment of Cancer - Non- Hodgkin Lymphoma- Low Grade- 20 items (EORTC QLQNHL- LG20) Questionnaire

    Time frame: Up to approximately 32 Months

  • Minimal residual disease (MRD) negativity

    Time frame: Up to approximately 32 Months

Eligibility criteria

Sex: AllAge: 18 Years and olderHealthy 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: 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 locations (31)

Local Institution - 0225

Birmingham, Alabama, 35205

Not Yet Recruiting
Site 0225 · Contact

Infirmary Cancer Care

Mobile, Alabama, 36607

Recruiting
Furhan Yunus, Site 0014 · Contact

Alaska Oncology and Hematology

Anchorage, Alaska, 99508

Recruiting
Steven Liu, Site 0074 · Contact

Local Institution - 0215

Little Rock, Arkansas, 72205

Not Yet Recruiting
Site 0215 · Contact

City of Hope Comprehensive Cancer Center

Duarte, California, 91010

Recruiting
Alex Herrera, Site 0072 · Contact

UCSF Helen Diller Medical Center at Parnassus Heights

San Francisco, California, 94143

Recruiting
Charalambos Andreadis, Site 0119 · Contact

Local Institution - 0008

Jacksonville, Florida, 32256

Not Yet Recruiting
Site 0008 · Contact

Local Institution - 0214

Tampa, Florida, 33606

Not Yet Recruiting
Site 0214 · Contact

Local Institution - 0217

Tampa, Florida, 33612

Not Yet Recruiting
Site 0217 · Contact

Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital

Marietta, Georgia, 30060

Recruiting
Dean Kirkel, Site 0021 · Contact

Southeastern Regional Medical Center

Newnan, Georgia, 30265

Recruiting
Sabarish Ayyappan, Site 0245 · Contact

Local Institution - 0240

Arlington Heights, Illinois, 60005

Not Yet Recruiting
Site 0240 · Contact

Local Institution - 0253

Iowa City, Iowa, 52242

Not Yet Recruiting
Site 0253 · Contact

Local Institution - 0243

Waukee, Iowa, 50309

Not Yet Recruiting
Site 0243 · Contact

Local Institution - 0216

Westwood, Kansas, 66205

Not Yet Recruiting
Site 0216 · Contact

Local Institution - 0218

Lexington, Kentucky, 40536

Not Yet Recruiting
Site 0218 · Contact

Local Institution - 0023

Baltimore, Maryland, 21201

Not Yet Recruiting
Site 0023 · Contact

Greater Baltimore Medical Center

Towson, Maryland, 21204

Recruiting
Zhuoyan Li, Site 0010 · Contact

Local Institution - 0145

Boston, Massachusetts, 02114

Not Yet Recruiting
Site 0145 · Contact

Local Institution - 0244

Boston, Massachusetts, 02215

Not Yet Recruiting
Site 0244 · Contact

Local Institution - 0247

Boston, Massachusetts, 02215

Not Yet Recruiting
Site 0247 · Contact

Hattiesburg Clinic Hematology/Oncology

Hattiesburg, Mississippi, 39401-7233

Recruiting
John Hrom, Site 0013 · Contact

Local Institution - 0144

Providence, Rhode Island, 02903

Not Yet Recruiting
Site 0144 · Contact

Texas Oncology - Central/South Texas

Austin, Texas, 78705

Recruiting
Jason Melear, Site 0237 · Contact

Local Institution - 0212

Fort Worth, Texas, 76104

Not Yet Recruiting
Site 0212 · Contact

Local Institution - 0230

San Antonio, Texas, 78240

Not Yet Recruiting
Site 0230 · Contact

Texas Oncology - Northeast Texas

Tyler, Texas, 75702

Recruiting
Habte Yimer, Site 0236 · Contact

Local Institution - 0238

Fairfax, Virginia, 22304

Not Yet Recruiting
Site 0238 · Contact

Hematology Oncology Associates of Fredericksburg

Fredericksburg, Virginia, 22408

Recruiting
Christopher Vaughn, Site 0030 · Contact

Blue Ridge Cancer Care

Roanoke, Virginia, 24014

Recruiting
Amanda Gillespie-Twardy, Site 0146 · Contact

Local Institution - 0143

Vancouver, Washington, 98684

Not Yet Recruiting
Site 0143 · Contact
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) | Cancerify