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OncoMatch/Clinical Trials/NCT06191744

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

Is NCT06191744 recruiting? Yes, currently enrolling (May 2026). This Phase 3 trial studies multiple treatments for follicular lymphoma (fl).

Phase 3RecruitingGenmabNCT06191744Data as of May 2026

Treatment: Epcoritamab · Prednisone · Rituximab · Lenalidomide · Doxorubicin · Vincristine · Cyclophosphamide · Obinutuzumab · BendamustineFollicular 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.

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Extracted eligibility criteria

Cancer type

Non-Hodgkin Lymphoma

Biomarker criteria

Required: CD20 overexpression (CD20+)

Have CD20+, histologically confirmed classic FL

Disease stage

Required: Stage III, IV, II WITH BULKY DISEASE

Grade: Grade 1Grade 2Grade 3a (5th edition of World Health Organization (WHO) Classification of Haematolymphoid Tumours)

Must have stage, III, IV or II with bulky disease >= 7cm

Performance status

ECOG 0–2(Ambulatory, capable of self-care)

Prior therapy

No prior treatment (treatment-naive required)
Max 0 prior lines

Structured fields extracted by AI. May contain errors — verify against the official protocol.

US trial 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

Showing up to 5 US sites. See all sites on ClinicalTrials.gov →

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