Georgia's Online Cancer Information Center

Find A Clinical Trial

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 Participants With Follicular Lymphoma

Status
Active
Cancer Type
Hematopoietic Malignancies
Lymphoma
Non-Hodgkin Lymphoma
Unknown Primary
Trial Phase
Phase III
Eligibility
18 Years and older, Male and Female
Study Type
Treatment
NCT ID
NCT06091254
Protocol IDs
R1979-HM-2298 (primary)
NCI-2024-00238
2022-502660-20-00
Study Sponsor
Regeneron Pharmaceuticals, Inc.

Summary

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 rituximab
(called the "comparator drug") 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)

- How the study drug affects quality of life and ability to complete routine daily
activities.

Eligibility

  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 Key

Treatment Sites in Georgia

City of Hope Atlanta


600 Celebrate Life Parkway
Newnan, GA 30265
770-400-6169
www.cityofhope.org/locations/atlanta/atlanta-cancer-center

**Clinical trials are research studies that involve people. These studies test new ways to prevent, detect, diagnose, or treat diseases. People who take part in cancer clinical trials have an opportunity to contribute to scientists’ knowledge about cancer and to help in the development of improved cancer treatments. They also receive state-of-the-art care from cancer experts... Click here to learn more about clinical trials.