Status:
ACTIVE_NOT_RECRUITING
Study of Subcutaneous Epcoritamab in Combination With Intravenous Rituximab and Oral Lenalidomide (R2) to Assess Adverse Events and Change in Disease Activity in Adult Participants With Follicular Lymphoma
Lead Sponsor:
Genmab
Collaborating Sponsors:
AbbVie
Conditions:
Follicular Lymphoma (FL)
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
Follicular Lymphoma (FL) is the second most common B-cell cancer and the most common type of cancer of lymphocytes. Unfortunately, this disease is incurable with conventional treatment and the disease...
Eligibility Criteria
Inclusion
- Eastern Cooperative Oncology Group (ECOG) performance status score 0 to 2.
- Participant has:
- Fluorodeoxyglucose-positron emission tomography (FDG-PET) scan demonstrating positive lesion compatible with computed tomography (CT) or magnetic resonance image (MRI)-defined anatomical tumor sites AND
- \>= 1 measurable nodal lesion (long axis \> 1.5 cm) or \>= 1 measurable extra-nodal lesion (long axis \> 1.0 cm) on CT scan or MRI.
- Histologically confirmed classic follicular lymphoma (FL) \[previously Grade 1 to 3a FL\] stage II, III, or IV with no evidence of histologic transformation to an aggressive lymphoma and CD20+ disease on most recent representative tumor biopsy based on the pathology report.
- Relapsed or refractory (R/R) disease to at least one prior systemic regimen that contained an anti-CD20 monoclonal antibody (mAb) in combination with chemotherapy. (Participant who received only prior anti-CD20 mAb monotherapy and/or radiation therapy is not eligible.)
- Eligible to receive R2 per investigator determination.
- Estimated Creatinine Clearance (CrCl) \>= 50 mL/min.
Exclusion
- Documented refractoriness to lenalidomide.
- Have lenalidomide exposure within 12 months prior to randomization.
Key Trial Info
Start Date :
September 20 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2029
Estimated Enrollment :
549 Patients enrolled
Trial Details
Trial ID
NCT05409066
Start Date
September 20 2022
End Date
December 1 2029
Last Update
July 28 2025
Active Locations (273)
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1
The University of Arizona Cancer Center - North Campus /ID# 228862
Tucson, Arizona, United States, 85719
2
University of Arkansas for Medical Sciences /ID# 227198
Little Rock, Arkansas, United States, 72205
3
Alta Bates Summit Medical Center for Research /ID# 229428
Berkeley, California, United States, 94705
4
Beverly Hills Cancer Center /ID# 231535
Beverly Hills, California, United States, 90211