Trial comparing treatments for Follicular Lymphoma (FL)
Official title 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
ClinicalTrials.gov ID: NCT06091254
What this study is testing
What is Odronextamab?
An investigational bispecific antibody being studied as a potential treatment for previously untreated follicular lymphoma. It is designed to bind both CD20 on lymphoma cells and CD3 on T cells, directing the immune system to attack the cancer cells.
Also referred to as REGN1979.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study wants to learn if odronextamab is safe and tolerable and how well it works compared to the usual treatment. It also looks at side effects, drug levels in the blood, immune reactions, and quality of life.
- Who it's for
- Adults who have follicular lymphoma that has not been treated before.
- What's involved
- Participants will receive odronextamab alone in an early safety part, then be randomly assigned to get odronextamab with chemotherapy or rituximab with chemotherapy. The study includes regular clinic visits, blood draws, and questionnaires about daily activities.
- Time commitment
- The trial runs for several months, with multiple treatment visits and follow‑up appointments during and after therapy.
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Diagnosis of Cluster of Differentiation 20\^+ (CD20\^+) FL Grade 1-3a, stage II bulky or stage III / IV
- Need for treatment as described in the protocol
- Have measurable disease on cross-sectional imaging documented by diagnostic imaging Computed Tomography (CT) or Magnetic Resonance Imaging (MRI)
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
- Adequate bone marrow function and hepatic function, as described in the protocol Key
You likely can't join if
- Central Nervous System (CNS) lymphoma or leptomeningeal lymphoma
- Histological evidence of transformation to a high-grade or diffuse large B-cell lymphoma
- Waldenström Macroglobulinemia (WM, lymphoplasmacytic lymphoma), Grade 3b follicular lymphoma, chronic lymphocytic leukemia, or small lymphocytic...
- Treatment with any systemic anti-lymphoma therapy
- Infections and allergy/hypersensitivity to study drug or excipient, as described in the protocol NOTE: Other protocol defined inclusion/exclusion...
The study team makes the final eligibility decision.
Where it is enrolling
- Tucson, Arizona, United States
- Los Angeles, California, United States
- Noblesville, Indiana, United States
- Boston, Massachusetts, United States
- Detroit, Michigan, United States
- New York, New York, United States
- Stony Brook, New York, United States
- Chapel Hill, North Carolina, United States
- Charlotte, North Carolina, United States
- Cleveland, Ohio, United States
- Nashville, Tennessee, United States
- Houston, Texas, United States
- Salt Lake City, Utah, United States
- Charlottesville, Virginia, United States
- Liverpool, New South Wales, Australia
- Bedford Park, South Australia, Australia
- Clayton, Victoria, Australia
- East Melbourne, Victoria, Australia
- Melbourne, Victoria, Australia
- Linz, Osterreich, Austria
+ 105 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Tucson, Arizona, United States; Los Angeles, California, United States; Noblesville, Indiana, United States; Boston, Massachusetts, United States; Detroit, Michigan, United States; New York, New York, United States and 119 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.