Odronextamab
DrugAdministered by intravenous (IV) infusion
Other names: REGN1979
NCT Number: NCT03888105
This study is researching an investigational drug, odronextamab, in adult patients B-cell non-Hodgkin's lymphoma (B-NHL).
The main purpose of this study is to assess the effectiveness of odronextamab in destroying cancer cells and to learn more about the safety of odronextamab.
The study is looking at several other research questions, including:
* To see if odronextamab works to destroy cancer cells * Side effects that may be experienced by people taking odronextamab * How odronextamab works in the body * How much odronextamab is present in the blood
This study is active but is not currently recruiting participants.
Notify Me18 year and older
All sexes
Interventional
Phase 2
Border Medical Oncology, East Albury, New South Wales, Australia
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Key Inclusion Criteria:
Patients should in the judgment of the investigator require systemic therapy for lymphoma at the time of study enrollment
Key Exclusion Criteria:
Note: Other protocol-defined Inclusion/Exclusion criteria apply
Administered by intravenous (IV) infusion
Other names: REGN1979
Time frame: Up to 52 weeks of study treatment
FL grade 1-3a/MZL
Time frame: Up to 36 weeks of study treatment
DLBCL/MCL/Other B-NHL
Time frame: Up to 52 weeks of study treatment
FL/MZL
Time frame: Up to 36 weeks of study treatment
DLBCL/MCL/Other B-NHL
Time frame: Up to 52 weeks of study treatment
FL grade 1-3a/MZL
Time frame: Up to 52 weeks of study treatment
FL grade 1-3a/MZL
Time frame: Up to 36 weeks of study treatment
DLBCL/MCL/Other B-NHL
Time frame: Up to 36 weeks of study treatment
DLBCL/MCL/Other B-NHL
Time frame: Approximately 194 weeks following the first dose
Time frame: Approximately 194 weeks following the first dose
Time frame: Approximately 194 weeks following the first dose
Time frame: Approximately 194 weeks following the first dose
Time frame: Approximately 194 weeks following the first dose
Time frame: Up to 52 weeks of study treatment
FL grade 1-3a/MZL
Time frame: Up to 52 weeks of study treatment
FL grade 1-3a/MZL
Time frame: Up to 36 weeks of study treatment
DLBCL/MCL/Other B-NHL
Time frame: Up to 36 weeks of study treatment
DLBCL/MCL/Other B-NHL
Time frame: Approximately 194 weeks following the first dose
Time frame: 12 weeks following end of treatment
End of infusion [EOI]; Concentration at a specified time t [Ct])
Time frame: 12 weeks following end of treatment
Time frame: 12 weeks following end of treatment
Time frame: 12 weeks following end of treatment
Time frame: Approximately 194 weeks following the first dose
The 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).
Time frame: Approximately 194 weeks following the first dose
Composed of the FACT-G plus the 15-item Lymphoma Subscale (LymS).
Time frame: Approximately 194 weeks following the first dose
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.
Regeneron Pharmaceuticals
Industry
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
Acronym: ELM-2
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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