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A Phase 3, Multicenter, Randomized, Open-Label Trial to Evaluate the Safety and Efficacy of Epcoritamab + Rituximab and Lenalidomide (R2) Compared to Chemoimmunotherapy in Previously Untreated Follicular Lymphoma (EPCORE™FL-2)
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 recurs in almost all patients. This study will assess how safe and effective epcoritamab is in combination with lenalidomide and rituximab (R2) in treating adult participants with previously untreated FL. Adverse events and change in disease condition will be assessed. Epcoritamab is an investigational drug being developed for the treatment of FL. Study doctors put the participants in 1 of 5 groups, called treatment arms. Each group receives a different treatment. Around 1095 adult participants with previously untreated FL will be enrolled in approximately 250 sites across the world. Participants will receive R2 (intravenous \[IV\] infusion of rituximab (R) and oral capsules of lenalidomide) alone or in combination with subcutaneous injections of epcoritamab. Participants may also receive investigator's choice chemoimmunotherapy (CIT): IV infusion of obinutuzumab (G) and IV injections of cyclophosphamide, IV injections of doxorubicin, IV injections of vincristine, oral tablets of prednisone (CHOP) \[G-CHOP\]/ R-CHOP or G and IV infusion of bendamustine (Benda) \[G-Benda\]/R-Benda. The total treatment duration will be 120 weeks for all arms except A2, which is 24 weeks of treatment. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
UCSF Fresno /ID# 264712
Fresno, California, United States
Scripps Mercy Hospital /ID# 265393
San Diego, California, United States
Sansum Clinic Research /ID# 261596
Santa Barbara, California, United States
Rocky Mountain Cancer Centers - Boulder /ID# 261203
Boulder, Colorado, United States
Christiana Care Health Service /ID# 261207
Newark, Delaware, United States
Cancer Specialists of North Florida - Jacksonville - AC Skinner Parkway /ID# 262445
Jacksonville, Florida, United States
Advent Health /ID# 261578
Orlando, Florida, United States
Orlando Health Cancer Institute /ID# 260983
Orlando, Florida, United States
Moffitt Cancer Center /ID# 259487
Tampa, Florida, United States
Beacon Cancer Care /ID# 260670
Coeur d'Alene, Idaho, United States
Start Date
February 5, 2024
Primary Completion Date
November 1, 2037
Completion Date
November 1, 2037
Last Updated
March 3, 2026
1,095
ESTIMATED participants
Epcoritamab
DRUG
Prednisone
DRUG
Rituximab
DRUG
Lenalidomide
DRUG
Doxorubicin
DRUG
Vincristine
DRUG
Cyclophosphamide
DRUG
Obinutuzumab
DRUG
Bendamustine
DRUG
Lead Sponsor
Genmab
Collaborators
NCT06043011
NCT04488354
Data Source & Attribution
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