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 (NCT05409066)
A Phase 3, Open-Label Study to Evaluate Safety and Efficacy of Epcoritamab in Combination With Rituximab and Lenalidomide (R2) Compared to R2 in Subjects With Relapsed or Refractory Follicular Lymphoma (EPCORE FL-1)
🩺 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 relapsed or refractory (R/R) 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 3 groups, called treatment arms. Each group receives a different treatment. Enrollment to one of the groups is closed. Around 500 adult participants with R/R FL will be enrolled in approximately 300 sites across the world. Participants will receive R2 (375 mg/m\^2 intravenous infusion of rituximab up to 5 cycles and oral capsules of 20 mg lenalidomide for up to 12 cycles) alone or in combination with subcutaneous injections of epcoritamab for up to 12 cycles (each cycle is 28 days). 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: Review the eligibility criteria below.
Location: The University of Arizona Cancer Center - North Campus /ID# 228862 — Tucson, Arizona
Age range: 18 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (273 Sites)
Showing the first 25 of 273 sites.
- The University of Arizona Cancer Center - North Campus /ID# 228862 — Tucson, Arizona
- University of Arkansas for Medical Sciences /ID# 227198 — Little Rock, Arkansas
- Alta Bates Summit Medical Center for Research /ID# 229428 — Berkeley, California
- Beverly Hills Cancer Center /ID# 231535 — Beverly Hills, California
- Long Beach Memorial Medical Ct /ID# 228997 — Long Beach, California
- University of Southern California /ID# 227195 — Los Angeles, California
- Valkyrie Clinical Trials /ID# 268502 — Los Angeles, California
- Duplicate_Emory University /ID# 227299 — Atlanta, Georgia
- Hawaii Cancer Care - Waterfront Plaza /ID# 262448 — Honolulu, Hawaii
- Northwestern University Feinberg School of Medicine /ID# 227248 — Chicago, Illinois
- Goshen Center for Cancer Care /ID# 227189 — Goshen, Indiana
- Community Health Network, Inc. /ID# 259756 — Indianapolis, Indiana
- Our Lady Of The Lake Regional Medical Center /ID# 251393 — Baton Rouge, Louisiana
- University of Maryland, Baltimore /ID# 227191 — Baltimore, Maryland
- Massachusetts General Hospital /ID# 245233 — Boston, Massachusetts
- UMass Memorial Medical Center /ID# 227323 — Worcester, Massachusetts
- Henry Ford Hospital /ID# 227250 — Detroit, Michigan
- St. Luke's Hospital - Chesterfield /ID# 247817 — Chesterfield, Missouri
- Intermountain Health St. Vincent Regional Hospital - Cancer Centers of Montana /ID# 251220 — Billings, Montana
- Morristown Medical Center /ID# 231427 — Morristown, New Jersey
- Roswell Park Cancer Institute /ID# 239128 — Buffalo, New York
- NYU Langone Hospital - Long Island /ID# 253343 — Mineola, New York
- NYU Laura and Isaac Perlmutter Cancer Center /ID# 227322 — New York, New York
- Icahn School of Medicine at Mount Sinai /ID# 227181 — New York, New York
- Memorial Sloan Kettering Cancer Center-Koch Center /ID# 227193 — New York, New York
💰 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.
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
- 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 — Fresno, California
- 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
- 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
Explore by condition: All Follicular Lymphoma (FL) clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Review the official NIH record below to find the coordinating site.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.