The purpose of this study is to assess the efficacy and safety of golcadomide in combination with rituximab in participants with newly diagnosed advanced stage Follicular Lymphoma (FL).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
90
Specified dose on specified days
Specified dose on specified days
Specified dose on specified days
Number of participants who achieve complete metabolic response (CMR) as assessed by Lugano criteria 2014
Golcadomide + Rituximab arms only
Time frame: Up to approximately 12 months from participant randomization
Number of participants with Adverse Events (AEs) as assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) criteria, v.5.0
Time frame: Up to 28 days after last dose
Number of participants with Treatment-emergent AEs (TEAEs) as assessed by the NCI CTCAE criteria, v.5.0
Time frame: Up to 28 days after last dose
Best Overall Response (OR)
Defined as achieving CMR or partial metabolic response (PMR) based on Lugano criteria 2014
Time frame: Up to approximately 12 months from participant randomization
Duration of Response (DoR)
Defined as time from first confirmed response (Complete Response (CR) or Partial Response (PR)) to disease progression, start of new anti-lymphoma therapy, or death
Time frame: Up to approximately 3 years after randomization of the last participant
Complete Response at 30 months (CR30)
Defined as achieving CR based on Lugano criteria at 30 months from randomization
Time frame: At approximately 30 months from randomization
Complete Metabolic Response at 6 months from the randomization (CMR6)
Defined as achieving CMR based on Lugano criteria 2014 at 6 months from randomization
Time frame: At approximately 6 months from randomization
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Specified dose on specified days
Specified dose on specified days
Specified dose on specified days
Specified dose on specified days
Local Institution - 0152
Birmingham, Alabama, United States
Local Institution - 0055
Anchorage, Alaska, United States
Local Institution - 0180
Phoenix, Arizona, United States
Local Institution - 0190
Tucson, Arizona, United States
Local Institution - 0035
San Francisco, California, United States
Local Institution - 0022
Washington D.C., District of Columbia, United States
Local Institution - 0209
Fort Myers, Florida, United States
Local Institution - 0005
Jacksonville, Florida, United States
Local Institution - 0210
St. Petersburg, Florida, United States
Local Institution - 0026
Tampa, Florida, United States
...and 46 more locations
Complete Metabolic Response at 12 months from the randomization (CMR12)
Defined as achieving CMR based on Lugano criteria 2014 at 12 months from randomization
Time frame: At approximately 12 months from randomization
Progression Free Survival (PFS)
Defined as time from date of randomization to first occurrence of disease progression or death from any cause
Time frame: Up to approximately 3 years from randomization of last participant
Overall Survival (OS)
Defined as time from date of randomization to death from any cause
Time frame: Up to approximately 3 years from randomization of last participant
Number of participants who achieve CMR as assessed by Lugano criteria 2014
Rituximab + Chemotherapy arm only
Time frame: Up to approximately 6 months from randomization