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
- Conditions
- B-cell Non-Hodgkin Lymphoma (B-NHL)
- Registration Number
- NCT03888105
- Lead Sponsor
- Regeneron Pharmaceuticals
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- Not specified
Key Inclusion Criteria:<br><br> 1. For the FL grade 1-3a cohort only: Central histopathologic confirmation of the FL<br> Grade 1 to 3a diagnosis must be obtained before study enrollment. Patients with FL<br> grade 3b are ineligible for this cohort but may be included in the other B-NHL<br> cohort. Follicular lymphoma subtyping is based on the World Health Organization<br> (WHO) classification (Swerdlow, 2017).<br><br> 2. Disease-specific cohorts:<br><br> Patients should in the judgment of the investigator require systemic therapy for<br> lymphoma at the time of study enrollment.<br><br> - FL grade 1-3a cohort: Patients with FL grade 1-3a that has relapsed after or is<br> refractory to at least 2 prior lines of systemic therapy, as defined in the<br> protocol<br><br> - DLBCL cohort: Patients with DLBCL that has relapsed after or is refractory to<br> at least 2 prior lines of systemic therapy as defined in the protocol<br><br> - MCL after BTK inhibitor therapy cohort: Patients with MCL who have relapsed or<br> refractory disease to at least one prior line of systemic therapy and had prior<br> treatment with a Bruton's tyrosine kinase (BTK) inhibitor.<br><br> - MZL cohort: Patients with MZL that have relapsed or is refractory to at least 2<br> prior lines of systemic therapy.<br><br> - Other B-NHL cohort: Patients with B-NHL other than FL grade 1-3a, DLBCL, MCL,<br> or MZL that has relapsed after or is refractory to at least 2 prior lines of<br> systemic therapy as defined in the protocol. New enrollment stopped for<br> patients with Burkitt lymphoma and Burkitt-like lymphoma.<br><br> 3. Measurable disease on cross sectional imaging as defined in the protocol documented<br> by diagnostic imaging (computed tomography (CT), or magnetic resonance imaging (MRI)<br><br> 4. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1<br><br> 5. Adequate bone marrow, hepatic, and renal function as defined in the protocol<br><br>Key Exclusion Criteria:<br><br> 1. Primary central nervous system (CNS) lymphoma or known involvement by non-primary<br> CNS Non-Hodgkin Lymphoma (NHL) (suspected CNS lymphoma should be evaluated by lumbar<br> puncture, as appropriate, in addition to the mandatory head CT or MRI).<br><br> 2. Treatment with any systemic anti-lymphoma therapy within 5 half-lives or within 28<br> days prior to first administration of study drug, whichever is shorter.<br><br> 3. History of allogeneic stem cell transplantation<br><br> 4. Continuous systemic corticosteroid treatment with more than 10 mg per day of<br> prednisone or anti-inflammatory equivalent within 72 hours of start of study drug<br><br> 5. History of neurodegenerative condition or CNS movement disorder. Patients with a<br> history of seizure within 12 months prior to study enrollment are excluded<br><br> 6. Another malignancy except B-NHL in the past 5 years, with the exception of<br> non-melanoma skin cancer that has undergone potentially curative therapy or in situ<br> cervical carcinoma, or any other tumor that has been deemed to be effectively<br> treated with definitive local control and with curative intent.<br><br> 7. Uncontrolled infection with human immunodeficiency virus (HIV), hepatitis B or<br> hepatitis C infection; cytomegalovirus (CMV) infection as noted by detectable levels<br> on a blood polymerase chain reaction (PCR) assay as defined in the protocol or other<br> uncontrolled infections<br><br> 8. Known hypersensitivity to both allopurinol and rasburicase<br><br> 9. Prior treatment with an anti-CD20 x anti-CD3 bispecific therapy<br><br>Note: Other protocol-defined Inclusion/Exclusion criteria apply
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Objective response rate (ORR), as assessed by independent central review;ORR, as assessed by independent central review
- Secondary Outcome Measures
Name Time Method