Clinical Trials Logo
  1. Home
  2. Other
  3. NCT03888105
  4. Details
NCT03888105 Clinical Trial

A Study to Assess the Anti-Tumor Activity and Safety of Odronextamab in Patients With B-cell Non-Hodgkin Lymphoma That Have Been Previously Treated

B-cell Non-Hodgkin Lymphoma (NHL) Clinical Trial

— ELM-2  

Official title:
An Open-Label Study to Assess the Anti-Tumor Activity and Safety of REGN1979, an Anti CD20 x Anti-CD3 Bispecific Antibody, in Patients With Relapsed or Refractory B-cell Non-Hodgkin Lymphoma

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT03888105
Other study ID # R1979-ONC-1625
Secondary ID 2017-002139-41
Status Recruiting
Phase Phase 2
First received
Last updated
Start date November 13, 2019
Est. completion date February 5, 2028

Study information
Verified date March 2024
Source Regeneron Pharmaceuticals
Contact Clinical Trials Administrator
Phone 844-734-6643
Email clinicaltrials@regeneron.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Primary objective is 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 (Cheson, 2014) 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 *1,2 - In patients with diffuse large B-cell lymphoma (DLBCL) *1,2 - In patients with mantle cell lymphoma (MCL) that has relapsed after or is refractory to a BTK inhibitor. This cohort will also include patients who have relapsed or have disease refractory to prior systemic therapy, or patients who have demonstrated intolerance to BTK inhibitor therapy, and who have progressed after other systemic therapy. - In patients with marginal zone lymphoma (MZL) *1 - In patients with other B-NHL subtypes *1 Secondary objectives are: - To assess the anti-tumor activity of single agent odronextamab in each of 5 disease-specific cohorts, as measured by: - ORR according to the Lugano Classification and as assessed by local investigator evaluation - Complete response (CR) rate according to the Lugano Classification and as assessed local by local investigator evaluation and independent central review - Progression-free survival (PFS)*3 - Overall survival (OS) - Duration of response (DOR)*3 - Disease control rate (DCR)*3 - To evaluate the safety and tolerability of odronextamab - To assess the pharmacokinetics (PK) of odronextamab - To assess the immunogenicity of odronextamab - To assess the effect of odronextamab on patient reported outcomes, including health-related quality of life (HRQL), as measured by the validated instruments European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30), Functional Assessment of Cancer Therapy-Lymphoma (FACT-Lym), and EuroQoL 5 Dimensions 3 Levels (EQ-5D-3L) - 1 that has relapsed after or is refractory to at least 2 prior lines of systemic therapy - 2 including an anti-CD20 antibody and an alkylating agent - 3 according to Lugano Classification and as assessed by independent central review and local investigator evaluation

Read more »

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Odronextamab
Administered by intravenous (IV) infusion
See more »

Sponsors (1)
Lead Sponsor Collaborator
Regeneron Pharmaceuticals

Countries where clinical trial is conducted

United States,  Australia,  Canada,  China,  France,  Germany,  Italy,  Japan,  Korea, Republic of,  Poland,  Singapore,  Spain,  Taiwan,  United Kingdom, 

Outcome
Type Measure Description Time frame Safety issue
Primary ORR (FL grade 1-3a/MZL) For each of the 5 disease-specific cohorts according to the Lugano Classification of response in malignant lymphoma (Cheson, 2014) and as assessed by independent central review. From first patient first dose until all patients have completed 52 weeks of study treatment or have withdrawn from the study
Primary ORR (DLBCL/MCL/Other B-NHL) For each of the 5 disease-specific cohorts according to the Lugano Classification of response in malignant lymphoma (Cheson, 2014) and as assessed by independent central review. From first patient first dose until all patients have completed 36 weeks of study treatment or have withdrawn from the study
Secondary ORR (FL/MZL) According to the Lugano Classification, as assessed by local investigator evaluation First patient first dose until all patients have completed 52 weeks of study treatment or have withdrawn from the study.
Secondary ORR (DLBCL/MCL/Other B-NHL) According to the Lugano Classification, as assessed by local investigator evaluation First patient first dose until all patients have completed 36 weeks of study treatment or have withdrawn from the study.
Secondary CR rate (FL grade 1-3a/MZL) According to the Lugano Classification and as assessed by local investigator evaluation and independent central review First patient first dose until all patients have completed 52 weeks of study treatment or have withdrawn from the study.
Secondary CR rate (DLBCL/MCL/Other B-NHL) According to the Lugano Classification and as assessed by local investigator evaluation and independent central review First patient first dose until all patients have completed 36 weeks of study treatment or have withdrawn from the study.
Secondary PFS According to the Lugano Classification and as assessed by independent central review and local investigator evaluation First patient first dose to disease progression or death due to any cause, whichever comes first, approximately 194 weeks following the first dose
Secondary OS First patient first dose to disease progression or death due to any cause, whichever comes first, approximately 194 weeks following the first dose
Secondary DOR According to the Lugano Classification and as assessed by independent central review and local investigator evaluation First patient first dose to disease progression or death due to any cause, whichever comes first, approximately 194 weeks following the first dose
Secondary DCR (FL grade 1-3a/MZL) According to the Lugano Classification and as assessed by independent central review and local investigator evaluation First patient first dose until all patients have completed 52 weeks of study treatment or have withdrawn from the study.
Secondary DCR (DLBCL/MCL/Other B-NHL) According to the Lugano Classification and as assessed by independent central review and local investigator evaluation First patient first dose until all patients have completed 36 weeks of study treatment or have withdrawn from the study.
Secondary Incidence and severity of treatment emergent adverse events (TEAEs) First patient first dose to disease progression or death due to any cause, whichever comes first, approximately 194 weeks following the first dose
Secondary Pharmacokinetics: Concentration of odronextamab End of infusion [EOI]; Concentration at a specified time t [Ct]) 12 weeks following end of treatment
Secondary Incidence of anti-drug antibodies (ADA) to odronextamab over time 12 weeks following end of treatment
Secondary Titer of anti-drug antibodies to odronextamab over time 12 weeks following end of treatment
Secondary Incidence of neutralizing antibodies (Nab) to odronextamab over time 12 weeks following end of treatment
Secondary Changes in scores of patient-reported outcomes as measured by EORTC QLQ-C30 EORTC QLQ-C30 is a self-reported, 30-item generic questionnaire developed to assess 15 domains: global health status scale, five functional scales (physical, role, emotional, cognitive, and social functioning) and nine symptom scales (fatigue, nausea, vomiting, pain, dyspnea, insomnia, appetite loss, constipation, diarrhea and financial difficulties). First patient first dose to disease progression or death due to any cause, whichever comes first, approximately 194 weeks following the first dose
Secondary Changes in scores of patient-reported outcomes as measured by FACT-Lym Composed of the FACT-G plus the 15-item Lymphoma Subscale (LymS). First patient first dose to disease progression or death due to any cause, whichever comes first, approximately 194 weeks following the first dose
Secondary Changes in scores of patient-reported outcomes as measured by EQ-5D-3L The EQ-5D-3L is a standardized instrument for use as a measure of health outcome. It is a health questionnaire that consists of the EQ-5D descriptive system and the EQ visual analogue scale (EQ VAS). The EQ-5D-3L descriptive system comprises the following 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 3 levels: no problems, some problems, extreme problems. First patient first dose to disease progression or death due to any cause, whichever comes first, approximately 194 weeks following the first dose
See also
  Status Clinical Trial Phase
Completed NCT02920697 - Dose-escalation Study of Oral Administration of S 55746 in Patients With Chronic Lymphocytic Leukaemia and B-Cell Non-Hodgkin Lymphoma Phase 1
Available NCT05619367 - A Compassionate Use (CU) Program of Odronextamab

External Links