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)

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.

Trial Details

NCT ID
NCT06911502
Phase
PHASE3
Sponsor
Celgene
Status
RECRUITING
Cancer Type
Non-Hodgkin Lymphoma Lymphoma
Interventions
  • Golcadomide
  • Rituximab
  • Lenalidomide
  • Cyclophosphamide
  • Doxorubicin
  • Vincristine
Locations (sample)
  • Birmingham, Alabama, United States|33.52066,-86.80249
  • Mobile, Alabama, United States|30.69436,-88.04305
  • Anchorage, Alaska, United States|61.21806,-149.90028
  • Little Rock, Arkansas, United States|34.74648,-92.28959
  • Duarte, California, United States|34.13945,-117.97729

Key Eligibility Criteria

  • \- Participant has histologically confirmed FL (Grade 1, 2, 3a or classic FL) as assessed by local pathology. Adequate fresh tumor biopsy tissue or…
  • \- 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).

For full eligibility, visit ClinicalTrials.gov.

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