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
Celgene
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.
Eligibility
- Age range
- 18+ years
- Sex
- All
- 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…
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
Locations (160)
- Local Institution - 0225Birmingham, Alabama
- Infirmary Cancer CareMobile, Alabama
- Alaska Oncology and HematologyAnchorage, Alaska
- Local Institution - 0215Little Rock, Arkansas
- City of Hope Comprehensive Cancer CenterDuarte, California
- UCSF Helen Diller Medical Center at Parnassus HeightsSan Francisco, California