BridgeMD
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 untreated follicular lymphoma
EU CTIS ID: 2022-502660-20-00
What this study is testing
Part 1 (Safety Run-in): Assess the safety, tolerability, and dose-limiting toxicities (DLTs) of odronextamab in participants with previously untreated follicular lymphoma (FL) Part 2 (Randomized Phase): To compare the efficacy of odronextamab versus investigator’s choice chemotherapy in participants with previously untreated FL as measured by complete response at 30 months (CR30) per independent central review
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Diagnoses 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
- NOTE: Other protocol defined inclusion criteria apply
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 lymphoma
- 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 exclusion criteria apply
The study team makes the final eligibility decision.
Where it's taking place
- Switzerland
- United Kingdom
- Brazil
- Australia
- Israel
- Taiwan
- United States
- Chile
- Turkey
- Canada
- Korea, Republic of
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 - 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, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Switzerland; United Kingdom; Brazil; Australia; Israel; Taiwan and 5 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.