Status:
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 Previously Untreated 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
- Diagnosis of follicular lymphoma (FL).
- Have CD20+, histologically confirmed classic FL (previously Grade 1 to 3a FL) at most recent representative tumor biopsy based on the local pathology report, according to the 5th edition of World Health Organization (WHO) Classification of Haematolymphoid Tumours.
- Are willing and able to comply with procedures required in the protocol.
- Must have stage, III, IV or II with bulky disease \>= 7cm).
- Must be in need of systemic treatment per investigator, as evidenced by meeting at least one of the Groupe d'Etude des Lymphomes Folliculaire (GELF) criteria.
- Has one or more target lesions:
- A positron emission tomography (PET)/computerized tomography (CT) scan demonstrating PET-positive lesion(s), and
- \>=1 measurable nodal lesion (long axis \>1.5cm) or \>=1 measurable extra-nodal lesion (long axis \>1.0 cm) on CT scan or MRI
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2.
- Able to receive at least one of the standard of care chemoimmunotherapy (CIT) treatment regimens: \[Arm B\] at the discretion of the Investigator, and rituximab and lenalidomide (R2) \[Arm C\].
- Have laboratory values meeting the criteria in the protocol.
Exclusion
- Had major surgery within 4 weeks prior to randomization.
- Have active cytomegalovirus (CMV) disease.
Key Trial Info
Start Date :
February 5 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2037
Estimated Enrollment :
1095 Patients enrolled
Trial Details
Trial ID
NCT06191744
Start Date
February 5 2024
End Date
November 1 2037
Last Update
January 7 2026
Active Locations (264)
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1
Scripps Mercy Hospital /ID# 265393
San Diego, California, United States, 92103
2
Sansum Clinic Research /ID# 261596
Santa Barbara, California, United States, 93105
3
Rocky Mountain Cancer Centers - Boulder /ID# 261203
Boulder, Colorado, United States, 80303
4
Christiana Care Health Service /ID# 261207
Newark, Delaware, United States, 19713