A Study to Evaluate the Efficacy and Safety of Golcadomide in Combination With Rituximab in Participants With Newly Diagnosed Advanced Stage Follicular Lymphoma

Phase 2

Recruiting

• Conditions: Lymphoma, Follicular
• Interventions: Drug: Golcadomide; Drug: Rituximab; Drug: Cyclophosphamide; Drug: Doxorubicin; Drug: Vincristine; Drug: Prednisone; Drug: Bendamustine

• Registration Number: NCT06425302
• Lead Sponsor: Celgene

Brief Summary

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-05-17
• Study First Submitted QC: 2024-05-17
• Study First Posted: 2024-05-22
• Study Start: 2024-08-30
• Status Verified: 2025-07
• Last Update Submitted: 2025-07-14
• Last Update Posted: 2025-07-16
• Primary Completion: 2026-11-23
• Study Completion: 2028-11-27

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Rituximab + Chemotherapy	Doxorubicin	R-CHOP (Rituximab, Doxorubicin, Vincristine, Cyclophosphamide, Prednisone) or Rituximab + Bendamustine
Golcadomide Dose 1 + Rituximab	Rituximab	-
Golcadomide Dose 2 + Rituximab	Golcadomide	-
Golcadomide Dose 2 + Rituximab	Rituximab	-
Rituximab + Chemotherapy	Cyclophosphamide	R-CHOP (Rituximab, Doxorubicin, Vincristine, Cyclophosphamide, Prednisone) or Rituximab + Bendamustine
Rituximab + Chemotherapy	Rituximab	R-CHOP (Rituximab, Doxorubicin, Vincristine, Cyclophosphamide, Prednisone) or Rituximab + Bendamustine
Rituximab + Chemotherapy	Vincristine	R-CHOP (Rituximab, Doxorubicin, Vincristine, Cyclophosphamide, Prednisone) or Rituximab + Bendamustine
Rituximab + Chemotherapy	Prednisone	R-CHOP (Rituximab, Doxorubicin, Vincristine, Cyclophosphamide, Prednisone) or Rituximab + Bendamustine
Rituximab + Chemotherapy	Bendamustine	R-CHOP (Rituximab, Doxorubicin, Vincristine, Cyclophosphamide, Prednisone) or Rituximab + Bendamustine
Golcadomide Dose 1 + Rituximab	Golcadomide	-

Primary Outcome Measures

Name	Time	Method
Number of participants who achieve complete metabolic response (CMR) as assessed by Lugano criteria 2014	Up to approximately 12 months from participant randomization	Golcadomide + Rituximab arms only

Secondary Outcome Measures

Name	Time	Method
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	Up to 28 days after last dose
Duration of Response (DoR)	Up to approximately 3 years after randomization of the last participant	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
Best Overall Response (OR)	Up to approximately 12 months from participant randomization	Defined as achieving CMR or partial metabolic response (PMR) based on Lugano criteria 2014
Complete Response at 30 months (CR30)	At approximately 30 months from randomization	Defined as achieving CR based on Lugano criteria at 30 months from randomization
Complete Metabolic Response at 6 months from the randomization (CMR6)	At approximately 6 months from randomization	Defined as achieving CMR based on Lugano criteria 2014 at 6 months from randomization
Complete Metabolic Response at 12 months from the randomization (CMR12)	At approximately 12 months from randomization	Defined as achieving CMR based on Lugano criteria 2014 at 12 months from randomization
Progression Free Survival (PFS)	Up to approximately 3 years from randomization of last participant	Defined as time from date of randomization to first occurrence of disease progression or death from any cause
Number of participants with Treatment-emergent AEs (TEAEs) as assessed by the NCI CTCAE criteria, v.5.0	Up to 28 days after last dose
Overall Survival (OS)	Up to approximately 3 years from randomization of last participant	Defined as time from date of randomization to death from any cause
Number of participants who achieve CMR as assessed by Lugano criteria 2014	Up to approximately 6 months from randomization	Rituximab + Chemotherapy arm only

Trial Locations

Locations (68)

Local Institution - 0152; 🇺🇸 Birmingham, Alabama, United States

Alaska Oncology and Hematology; 🇺🇸 Anchorage, Alaska, United States

Mayo Clinic in Arizona - Phoenix; 🇺🇸 Phoenix, Arizona, United States

Arizona Oncology Associates, PC - HOPE; 🇺🇸 Tucson, Arizona, United States

UCSF Helen Diller Medical Center at Parnassus Heights; 🇺🇸 San Francisco, California, United States

Georgetown University Medical Center; 🇺🇸 Washington, District of Columbia, United States

Florida Cancer Specialists - South; 🇺🇸 Fort Myers, Florida, United States

Mayo Clinic in Florida; 🇺🇸 Jacksonville, Florida, United States

Florida Cancer Specialists - North; 🇺🇸 Saint Petersburg, Florida, United States

Tampa General Hospital; 🇺🇸 Tampa, Florida, United States

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