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 (GOLSEEK-4)

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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 (GOLSEEK-4)

Status
Active
Cancer Type
Hematopoietic Malignancies
Lymphoma
Non-Hodgkin Lymphoma
Unknown Primary
Trial Phase
Phase III
Eligibility
18 Years and older, Male and Female
Study Type
Treatment
NCT ID
NCT06911502
Protocol IDs
CA073-1003 (primary)
NCI-2025-04984
2024-519152-82
U1111-1314-3909
Study Sponsor
Celgene Corporation

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

  1. Participant has histologically confirmed FL (Grade 1, 2, or 3a) 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.
  2. Relapsed or refractory disease:
  3. Relapsed FL is defined as relapse after an initial response of CR or PR to the most recent prior therapy.
  4. Refractory FL is defined as best response of SD or PD to the most recent prior therapy.
  5. Eastern Cooperative Oncology Group (ECOG) 0-2 (ECOG 3 authorized if it is due to lymphoma and not comorbidities).
  6. 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.
  7. Participants with an indication for anti-lymphoma treatment as per investigator assessment based on modified Groupe d'Etude des Lymphomes Folliculaires (GELF) criteria.
  8. 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.
  9. Lab parameters:
  10. Absolute neutrophil count (ANC) = 1,000 cells/mm3 (1.0 x 109 /L),
  11. PLT count = 75,000 cells/mm3 (75 x 109 /L)
  12. Hb = 7.5 g/dL
  13. estimated glomerular filtration rate (eGFR) = 30 ml/min/1.73m².
  14. 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.
  15. 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
  16. Adequate cardiac function for participants receiving anthracycline-based chemotherapy, defined as left ventricular ejection fraction (LVEF) = 40% as assessed by echocardiogram (ECHO) as standard of care or multi-gated acquisition scan (MUGA)

Treatment Sites in Georgia

Northwest Georgia Oncology Centers - Cobb Hospital (Hiram)


144 Bill Carruth Parkway
Suite 3100
Hiram, GA 30141
770-281-5131
www.ngoc.com

Northwest Georgia Oncology Centers - Douglasville


6002 Professional Parkway
Suite 140
Douglasville, GA 30134
770-281-5101
www.ngoc.com

Northwest Georgia Oncology Centers - Tanner Medical Center Villa Rica


157 Clinic Avenue
Suite 202
Carrollton, GA 30117
770-281-5101
www.ngoc.com

Northwest Georgia Oncology Centers (NGOC) - Cobb Hospital (Marietta)


340 Kennestone Hospital Blvd.
Suite 100
Marietta, GA 30060
770-281-5101


**Clinical trials are research studies that involve people. These studies test new ways to prevent, detect, diagnose, or treat diseases. People who take part in cancer clinical trials have an opportunity to contribute to scientists’ knowledge about cancer and to help in the development of improved cancer treatments. They also receive state-of-the-art care from cancer experts... Click here to learn more about clinical trials.