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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
EU CTIS ID: 2022-502113-28-00
What this study is testing
Part 1 Assess the safety, tolerability, and dose limiting toxicities (DLTs) of odronextamab in combination with chemotherapy in participants with previously untreated follicular lymphoma (FL) and participants with relapsed or refractory (R/R) FL (Part 1A only), and to determine an optimal dosing regimen of odronextamab (Part 1B) in previously untreated participants with FL to combine with CHOP/CVP in Part 2. Part 2 To compare the efficacy of odronextamab in combination with chemotherapy versus rituximab in combination with chemotherapy in participants with previously untreated FL as measured by complete response rate 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
- Have diagnosis of cluster of differentiation 20 positive (CD20+) FL grade 1-3a, stage II bulky or stage III / IV
- Have measurable disease on cross sectional imaging documented by diagnostic computed tomography [CT], or magnetic resonance imaging [MRI] imaging, as described in the protocol
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
- Adequate bone marrow and hepatic function
- NOTE: Other protocol defined inclusion criteria apply
You likely can't join if
- Participants with central nervous system lymphoma or leptomeningeal lymphoma
- Participants with histological evidence of transformation to a high-grade or diffuse large B-cell lymphoma
- Participants with Waldenström macroglobulinemia (WM, lymphoplasmacytic lymphoma), grade 3b follicular lymphoma, chronic lymphocytic leukemia or small lymphocytic lymphoma
- Recent major surgery and history or organ transplantation
- 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 exclusion criteria apply
The study team makes the final eligibility decision.
Where it's taking place
- Korea, Republic of
- Taiwan
- Chile
- Israel
- United States
- Thailand
- Brazil
- Australia
- Turkey
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 Korea, Republic of; Taiwan; Chile; Israel; United States; Thailand and 3 more location(s). Enter your location above to see the nearest site and check your eligibility.
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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.