- 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 — Recruiting • Phase III • Oncology • NCT06091254.
- What is being tested: Odronextamab, a novel bispecific antibody, is being evaluated for safety, tolerability, and efficacy compared to rituximab combined with chemotherapy in previously untreated follicular lymphoma patients.
- Patient eligibility overview: The trial recruits adult participants with previously untreated follicular lymphoma (grade 1-3a non-Hodgkin lymphoma) who have not received prior systemic therapy for their condition.
- Quick orientation before opening the registry record.
- Checking recruitment status, phase and sponsor at a glance.
- Connecting this trial to nearby guidelines, Drug Science and education.
This study is researching an experimental drug called odronextamab, referred to as study drug. The study is focused on participants with previously untreated follicular lymphoma (a type of non-Hodgkin lymphoma or NHL). This study will be made up of two parts: Part 1 (non-randomized) and Part 2 (randomized - controlled). The aim of Part 1 of the study is to see how safe and tolerable the study drug is when given alone. The aim of Part 2 of the study is to see how the study drug works compared to…
- Key Inclusion Criteria: 1. Diagnosis of Cluster of Differentiation 20^+ (CD20^+) FL Grade 1-3a, stage II bulky or stage III / IV 2. Need for treatment as described in the protocol 3. Have measurable disease on cross-sectional imaging documented by diagnostic imaging Computed Tomography (CT) or Magnetic Resonance Imaging (MRI) 4. Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 5. Adequate bone marrow function and hepatic function, as described in the protocol Key
Use the source registry for the full inclusion and exclusion criteria before discussing referral or enrolment.