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
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
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. The aim of Part 2 of the study is to see how the study drug works compared to 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 your blood at different times
- Whether the body makes antibodies against the study drug (which could make the drug less
effective or could lead to side effects)
- The impact from the study drug on your quality of life and ability to complete routine
daily activities.
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. The aim of Part 2 of the study is to see how the study drug works compared to 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 your blood at different times
- Whether the body makes antibodies against the study drug (which could make the drug less
effective or could lead to side effects)
- The impact from the study drug on your quality of life and ability to complete routine
daily activities.
Not Available
Phase III
Adults
Not Available
Not Available
Bhaskar, Shakthi
International
Vanderbilt University
05-22-2025
Eligibility
18 Years
BOTH
NO
Inclusion Criteria:
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
Exclusion Criteria:
Central nervous system (CNS) lymphoma or leptomeningeal lymphoma
Histological evidence of transformation to a high-grade or diffuse large B-cell lymphoma
Waldenstrm 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
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
Exclusion Criteria:
Central nervous system (CNS) lymphoma or leptomeningeal lymphoma
Histological evidence of transformation to a high-grade or diffuse large B-cell lymphoma
Waldenstrm 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
