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
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
Study locations (31)
Local Institution - 0225
Birmingham, Alabama, 35205
Infirmary Cancer Care
Mobile, Alabama, 36607
Alaska Oncology and Hematology
Anchorage, Alaska, 99508
Local Institution - 0215
Little Rock, Arkansas, 72205
City of Hope Comprehensive Cancer Center
Duarte, California, 91010
UCSF Helen Diller Medical Center at Parnassus Heights
San Francisco, California, 94143
Local Institution - 0008
Jacksonville, Florida, 32256
Local Institution - 0214
Tampa, Florida, 33606
Local Institution - 0217
Tampa, Florida, 33612
Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital
Marietta, Georgia, 30060
Southeastern Regional Medical Center
Newnan, Georgia, 30265
Local Institution - 0240
Arlington Heights, Illinois, 60005
Local Institution - 0253
Iowa City, Iowa, 52242
Local Institution - 0243
Waukee, Iowa, 50309
Local Institution - 0216
Westwood, Kansas, 66205
Local Institution - 0218
Lexington, Kentucky, 40536
Local Institution - 0023
Baltimore, Maryland, 21201
Greater Baltimore Medical Center
Towson, Maryland, 21204
Local Institution - 0145
Boston, Massachusetts, 02114
Local Institution - 0244
Boston, Massachusetts, 02215
Local Institution - 0247
Boston, Massachusetts, 02215
Hattiesburg Clinic Hematology/Oncology
Hattiesburg, Mississippi, 39401-7233
Local Institution - 0144
Providence, Rhode Island, 02903
Texas Oncology - Central/South Texas
Austin, Texas, 78705
Local Institution - 0212
Fort Worth, Texas, 76104
Local Institution - 0230
San Antonio, Texas, 78240
Texas Oncology - Northeast Texas
Tyler, Texas, 75702
Local Institution - 0238
Fairfax, Virginia, 22304
Hematology Oncology Associates of Fredericksburg
Fredericksburg, Virginia, 22408
Blue Ridge Cancer Care
Roanoke, Virginia, 24014
Local Institution - 0143
Vancouver, Washington, 98684