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 (NCT06191744)
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)
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: To join this study, participants generally need to meet the listed inclusion criteria (11 items) and avoid the listed exclusions (3 items).
Location: UCSF Fresno /ID# 264712 — Fresno, California
Age range: 18 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistCheck every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).
Usually NOT eligible if any of the following apply:
- Exclusion Criteria:
- Had major surgery within 4 weeks prior to randomization.
- Have active cytomegalovirus (CMV) disease.
🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.
📍 All Participating Trial Locations (266 Sites)
Showing the first 25 of 266 sites.
- UCSF Fresno /ID# 264712 — Fresno, California
- Scripps Mercy Hospital /ID# 265393 — San Diego, California
- Sansum Clinic Research /ID# 261596 — Santa Barbara, California
- Rocky Mountain Cancer Centers - Boulder /ID# 261203 — Boulder, Colorado
- Christiana Care Health Service /ID# 261207 — Newark, Delaware
- Cancer Specialists of North Florida - Jacksonville - AC Skinner Parkway /ID# 262445 — Jacksonville, Florida
- Advent Health /ID# 261578 — Orlando, Florida
- Orlando Health Cancer Institute /ID# 260983 — Orlando, Florida
- Moffitt Cancer Center /ID# 259487 — Tampa, Florida
- Beacon Cancer Care - Coeur d'Alene /ID# 260670 — Coeur d'Alene, Idaho
- Northwestern Medicine - Northwestern Memorial Hospital /ID# 259814 — Chicago, Illinois
- Cancer Care Specialists Of Central Illinois /ID# 272464 — Decatur, Illinois
- Loyola University /ID# 259462 — Maywood, Illinois
- Illinois Cancer Care, PC /ID# 261526 — Peoria, Illinois
- Fort Wayne Medical Oncology and Hematology- South Office /ID# 259583 — Fort Wayne, Indiana
- University of Iowa Health Care /ID# 262132 — Des Moines, Iowa
- University of Louisville Hospital /ID# 260544 — Louisville, Kentucky
- Norton Cancer Institute - St. Matthews /ID# 261076 — Louisville, Kentucky
- New England Cancer Specialists - Westbrook /ID# 260672 — Westbrook, Maine
- University of Maryland, Baltimore /ID# 259538 — Baltimore, Maryland
- Center for Cancer and Blood Disorders-American Oncology Partners of Maryland /ID# 259476 — Bethesda, Maryland
- St. Luke's Hospital - Chesterfield /ID# 260489 — Chesterfield, Missouri
- Intermountain Health St Vincent Regional Hospital - Cancer Centers of Montana /ID# 260006 — Billings, Montana
- Nebraska Cancer Specialists (NCS) - Regional Cancer Center - St Francis Location /ID# 262506 — Grand Island, Nebraska
- Nebraska Hematology-Oncology /ID# 269692 — Lincoln, Nebraska
📞 Contact the Study Coordinator
Phone: (877) 827-3222
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
- 💵 Compensation indicated: Participants will receive R2 (intravenous \[IV\] infusion of rituximab (R) and oral capsules of lenalidomide) alone or in combination with subcutaneous injections of epcoritamab.
More studies in Follicular Lymphoma (FL)
- A Phase III Trial Comparing Tisagenlecleucel to Standard of Care (SoC) in Adult Participants With r/r Follicular Lymphoma — Camperdown, New South Wales
- A Trial to Learn if Odronextamab is Safe and Well-Tolerated and How Well it Works Compared to Rituximab Combined With Different Types of Chemotherapy for Adult Participants With Previously Untreated Follicular Lymphoma — Tucson, Arizona
- A Trial to Learn if Odronextamab Combined With Chemotherapy is Safe and Well-Tolerated and How Well it Works Compared to Rituximab Combined With Chemotherapy for Adult Participants With Follicular Lymphoma — Plantation, Florida
- 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 — Tucson, Arizona
Explore by condition: All Follicular Lymphoma (FL) clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.