ClinicaliQ Trial Snapshot
- 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 — Recruiting • Phase III • Oncology • NCT06191744.
- What is being tested: A triple combination therapy consisting of subcutaneous epcoritamab (bispecific antibody), intravenous rituximab (monoclonal antibody), and oral lenalidomide (immunomodulatory agent) in previously untreated follicular lymphoma patients, with primary focus on safety profile and disease response.
- Patient eligibility overview: Adults with newly diagnosed follicular lymphoma who have not received prior treatment, with the study evaluating tolerability and efficacy across this treatment-Phase IIIïve population.
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What This Trial Is Studying
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…
Eligibility Snapshot
- : * 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.
Use the source registry for the full inclusion and exclusion criteria before discussing referral or enrolment.