UK Center for Clinical and Translational Science

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

Purpose

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. Follicular lymphoma is a type of non-Hodgkin lymphoma or NHL. Participants with follicular lymphoma that has come back after treatment (called "relapsed") or did not respond to treatment (called "refractory") are eligible to take part only in Part 1A of the study. This study is made up of 3 parts: Part 1A (non-randomized), Part 1B and Part 2 (randomized - controlled). The aim of Part 1A and Part 1B of the study is to see how safe and tolerable the study drug in combination with chemotherapy is and to determine the dose and schedule of the study drug to be combined with chemotherapy to be used in Part 2 of the study. The aim of Part 2 of the study is to assess how effective the combination of the study drug with chemotherapy is in comparison with the combination of rituximab and chemotherapy (the current standard-of-care for NHL). Standard-of-care means the usual medication expected and used when receiving treatment for a condition. The study is looking at several other research questions, including: - What side effects may happen from taking the study drug - How much study drug is in the blood at different times - Whether the body makes antibodies against the study drug (which could make the study drug less effective or could lead to side effects) - The impact from the study drug on quality-of-life and ability to complete routine daily activities

Condition

Follicular Lymphoma (FL)

Eligibility

Eligible Ages: Over 18 Years
Eligible Genders: All
Accepts Healthy Volunteers: No

Inclusion Criteria

Have diagnosis of cluster of differentiation 20 positive (CD20+) FL grade 1-3a, stage II bulky or stage III / IV 1. For Part 1A: previously untreated participants who have Follicular Lymphoma International Prognostic Index (FLIPI)-1 score of 3 to 5, or R/R FL 2. For Part 1B: previously untreated participants who have FLIPI-1 score of 3 to 5 3. For Part 2: previously untreated participants who have FLIPI-1 score of 0 to 5 2. Have measurable disease on cross sectional imaging documented by diagnostic computed tomography [CT], or magnetic resonance imaging [MRI] imaging, as described in the protocol 3. Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 4. Adequate bone marrow and hepatic function.

Exclusion Criteria

Participants with central nervous system lymphoma or leptomeningeal lymphoma 2. Participants with histological evidence of transformation to a high-grade or diffuse large B-cell lymphoma 3. Participants with Waldenström macroglobulinemia (WM, lymphoplasmacytic lymphoma), grade 3b follicular lymphoma, chronic lymphocytic leukemia or small lymphocytic lymphoma 4. Recent major surgery and history or organ transplantation 5. A malignancy other than NHL unless the participant is adequately and definitively treated and any other significant active disease or medical condition that could interfere with the conduct of the study or put the participant at significant risk, as described in the protocol. Note: Other protocol-defined Inclusion/Exclusion criteria apply

Study Design

Phase: Phase 3
Study Type: Interventional
Allocation: Randomized
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
Masking: None (Open Label)

Arm Groups

Arm	Description	Assigned Intervention
Experimental Odronextamab + Chemotherapy	Part 1 of the study includes ordonextamab dose escalation for participants with previously untreated FL and relapsed/refractory FL (Part 1A only) followed by a randomized exploration of 2 regimens of odronextamab (Odro) and cyclophosphamide, doxorubicin, vincristine, prednisone (CHOP) with the objective of dose optimization (Part 1B) in previously untreated patients with FL.	Drug: Odronextamab Administered by intravenous (IV) infusion Other names: REGN1979 Drug: Cyclophosphamide Administered by IV infusion Other names: Cytoxan Drug: Doxorubicin Administered by IV infusion Other names: Adriamycin Drug: Prednisone/Prenisolone Administered orally (PO) Other names: Deltasone/Omnipred
Active Comparator Rituximab + Chemotherapy	In Part 2 only, participants will be randomized 1:1:1 to receive rituximab (R) with chemotherapy (CHOP), followed by rituximab monotherapy maintenance.	Drug: Odronextamab Administered by intravenous (IV) infusion Other names: REGN1979 Drug: Rituximab Administered by IV infusion, or subcutaneous (SC) Other names: Rituxan Drug: Cyclophosphamide Administered by IV infusion Other names: Cytoxan Drug: Doxorubicin Administered by IV infusion Other names: Adriamycin Drug: Vincristine Administered by IV infusion Other names: Oncovin Drug: Prednisone/Prenisolone Administered orally (PO) Other names: Deltasone/Omnipred
Experimental Odronextamab + Chemotherapy + Maintenance	In Part 2, participants will be randomized 1:1:1 to receive odronextamab with chemotherapy [CHOP, or cyclophosphamide, vincristine, and prednisone (CVP)], followed by odronextamab monotherapy maintenance.	Drug: Odronextamab Administered by intravenous (IV) infusion Other names: REGN1979 Drug: Vincristine Administered by IV infusion Other names: Oncovin
Experimental Odronextamab + Chemotherapy + No maintenance	In Part 2, participants will be randomized 1:1:1 to receive odronextamab with chemotherapy (CHOP, or CVP) without maintenance.	Drug: Odronextamab Administered by intravenous (IV) infusion Other names: REGN1979 Drug: Vincristine Administered by IV infusion Other names: Oncovin

Recruiting Locations

UK Center for Clinical and Translational Science and nearby locations

University of Kentucky
Lexington, Kentucky 40536

More Details

NCT ID: NCT06097364
Status: Recruiting
Sponsor: Regeneron Pharmaceuticals

Study Contact

Clinical Trials Administrator
844-734-6643
clinicaltrials@regeneron.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.