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A Study to Assess the Anti-Tumor Activity and Safety of Odronextamab in Adult Patients With B-cell Non-Hodgkin Lymphoma Who Have Been Previously Treated with Other Cancer Therapies
EU CTIS ID: 2024-511747-25-00
What this study is testing
To assess the anti-tumor activity of single agent Odronextamab as measured by the objective response rate (ORR) according to the Lugano Classification of response in malignant lymphoma and as assessed by independent central review in each of the following B-cell non-Hodgkin lymphoma (B-NHL) subgroups: - In patients with follicular lymphoma (FL) grade 1-3a that has relapsed after or is refractory to at least 2 prior lines of systemic therapy including an anti-CD20 antibody and an alkylating agent - In patients with diffuse large B-cell lymphoma (DLBCL) that has relapsed after or is refractory to at least 2 prior lines of systemic therapy including an anti-CD20 antibody and an alkylating agent - In patients with mantle cell lymphoma (MCL) who have relapsed or refractory disease to at least one prior line of systemic therapy and had prior Bruton’s tyrosine kinase (BTK) inhibitor treatment. - In patients with marginal zone lymphoma (MZL) that has relapsed after or is refractory to at least 2 prior lines of systemic therapy - In patients with other B-NHL subtypes that has relapsed after or is refractory to at least 2 prior lines of systemic therapy
- Therapeutic exploratory (Phase II)
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
- For the FL grade 1-3a cohort only: Central histopathologic confirmation of the FL Grade 1 to 3a diagnosis must be obtained before study enrollment. Patients with FL grade 3b are ineligible for this cohort but may be included in the "other B-NHL" cohort. Follicular lymphoma subtyping is based on the World Health Organization (WHO) classification
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
- Other protocol-defined inclusion criteria apply
- Adequate bone marrow, hepatic, and renal function as defined in the protocol
- Disease-specific cohorts: Patients should in the judgment of the investigator require systemic therapy for lymphoma at the time of study enrollment. FL grade 1-3a cohort: Patients with FL grade 1-3a that has relapsed after or is refractory to at least 2 prior lines of systemic therapy, as defined in the protocol
- DLBCL cohort: Patients with DLBCL that has relapsed after or is refractory to at least 2 prior lines of systemic therapy as defined in the protocol
You likely can't join if
- Primary central nervous system (CNS) lymphoma or known involvement by non-primary CNS Non-Hodgkin Lymphoma (NHL) (suspected CNS lymphoma should be evaluated by lumbar puncture, as appropriate, in addition to the mandatory head CT or MRI).
- Prior treatment with an anti-CD20 x anti-CD3 bispecific therapy
- Other protocol-defined exclusion criteria apply
- Treatment with any systemic anti-lymphoma therapy within 5 half-lives or within 28 days prior to first administration of study drug, whichever is shorter.
- History of allogeneic stem cell transplantation
- Criterion removed
See the full eligibility criteria
- For the FL grade 1-3a cohort only: Central histopathologic confirmation of the FL Grade 1 to 3a diagnosis must be obtained before study enrollment. Patients with FL grade 3b are ineligible for this cohort but may be included in the "other B-NHL" cohort. Follicular lymphoma subtyping is based on the World Health Organization (WHO) classification
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
- Other protocol-defined inclusion criteria apply
- Adequate bone marrow, hepatic, and renal function as defined in the protocol
- Disease-specific cohorts: Patients should in the judgment of the investigator require systemic therapy for lymphoma at the time of study enrollment. FL grade 1-3a cohort: Patients with FL grade 1-3a that has relapsed after or is refractory to at least 2 prior lines of systemic therapy, as defined in the protocol
- DLBCL cohort: Patients with DLBCL that has relapsed after or is refractory to at least 2 prior lines of systemic therapy as defined in the protocol
- MCL after BTK inhibitor therapy cohort: Patients with MCL who have relapsed or refractory disease to at least one prior line of systemic therapy and had prior treatment with a BTK inhibitor.
- MZL cohort: Patients with MZL that have relapsed or is refractory to at least 2 prior lines of systemic therapy.
- Other B-NHL cohort: Patients with B-NHL other than FL grade 1-3a, DLBCL, MCL, or MZL that has relapsed after or is refractory to at least 2 prior lines of systemic therapy as defined in the protocol. New enrollment stopped for patients with Burkitt lymphoma and Burkitt-like lymphoma.
- Patients should in the judgment of the investigator require systemic therapy for lymphoma at the time of study enrollment
- Measurable disease on cross sectional imaging as defined in the protocol documented by diagnostic imaging (computed tomography (CT), or magnetic resonance imaging (MRI)
- Primary central nervous system (CNS) lymphoma or known involvement by non-primary CNS Non-Hodgkin Lymphoma (NHL) (suspected CNS lymphoma should be evaluated by lumbar puncture, as appropriate, in addition to the mandatory head CT or MRI).
- Prior treatment with an anti-CD20 x anti-CD3 bispecific therapy
- Other protocol-defined exclusion criteria apply
- Treatment with any systemic anti-lymphoma therapy within 5 half-lives or within 28 days prior to first administration of study drug, whichever is shorter.
- History of allogeneic stem cell transplantation
- Criterion removed
- Continuous systemic corticosteroid treatment with more than 10 mg per day of prednisone or anti-inflammatory equivalent within 72 hours of start of study drug
- History of neurodegenerative condition or CNS movement disorder. Patients with a history of seizure within 12 months prior to study enrollment are excluded
- Another malignancy except B-NHL in the past 5 years, with the exception of non-melanoma skin cancer that has undergone potentially curative therapy or in situ cervical carcinoma, or any other tumor that has been deemed to be effectively treated with definitive local control and with curative intent.
- Uncontrolled infection with human immunodeficiency virus (HIV), hepatitis B or hepatitis C infection; cytomegalovirus (CMV) infection as noted by detectable levels on a blood polymerase chain reaction (PCR) assay as defined in the protocol or other uncontrolled infections
- Known hypersensitivity to both allopurinol and rasburicase
The study team makes the final eligibility decision.
Where it's taking place
- United Kingdom
- Canada
- China
- Taiwan
- Singapore
- Japan
- United States
- Korea, Republic of
- Australia
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, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include United Kingdom; Canada; China; Taiwan; Singapore; Japan and 3 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.