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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
400
Specified dose on specified days
Specified dose on specified days
Specified dose on specified days
Specified dose on specified days
Specified dose on specified days
Specified dose on specified days
Specified dose on specified days
Specified dose on specified days
Local Institution - 0225
Birmingham, Alabama, United States
NOT_YET_RECRUITINGInfirmary Cancer Care
Mobile, Alabama, United States
RECRUITINGAlaska Oncology and Hematology
Anchorage, Alaska, United States
RECRUITINGLocal Institution - 0215
Little Rock, Arkansas, United States
Progression free survival (PFS) assessed by Independent Review Adjudication committee (IRAC)
Time frame: Up to approximately 32 Months
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
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City of Hope Comprehensive Cancer Center
Duarte, California, United States
RECRUITINGUCSF Helen Diller Medical Center at Parnassus Heights
San Francisco, California, United States
RECRUITINGLocal Institution - 0008
Jacksonville, Florida, United States
NOT_YET_RECRUITINGLocal Institution - 0214
Tampa, Florida, United States
NOT_YET_RECRUITINGLocal Institution - 0217
Tampa, Florida, United States
NOT_YET_RECRUITINGNorthwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital
Marietta, Georgia, United States
RECRUITING...and 150 more locations