Last updated 9 days ago

A Study to Compare How Well Odronextamab Combined With Chemotherapy Works and How Safe it is Against Rituximab Combined With Chemotherapy, in Patients With Previously Untreated Diffuse Large B-cell Lymphoma

904 patients around the world
Available in Spain, Chile, United States
Regeneron Pharmaceuticals
2Research sites
904Patients around the world

This study is for people with

Non-Hodgkin Lymphoma
Diffuse large B-cell lymphoma

Requirements for the patient

From 18 Years
All Gender

Medical requirements

Previously untreated participants for lymphoma with documented cluster of differentiation 20+ (CD20+) DLBCL, as described in the protocol OR relapsed or refractory DLBCL (Part 1A only).
Measurable disease with at least one nodal lesion or at least one extranodal lesion, as described in the protocol.
Eastern Cooperative Oncology Group (ECOG) performance status ≤2.
Life expectancy ≥ 12 months.
International Prognostic Index (IPI) of 3 to 5 (part 1 only) and ≥2 (part 2) for untreated DLBCL only.
Adequate hematologic and organ function, as defined in the protocol.
Primary central nervous system (CNS) lymphoma or known involvement by non-primary CNS NHL and history or current relevant CNS pathology.
Another active malignancy, significant active disease or medical condition, as described in the protocol.
Peripheral neuropathy Grade ≥3.
Treatment with any systemic anti-lymphoma therapy.
Any investigational therapy within 28 days or 5 half-lives of the drug, whichever is shorter, prior to the start of study treatment.
Recent major surgery, prior organ transplantation, or standard radiotherapy, as described in the protocol.
Allergy/hypersensitivity to study drugs, as described in the protocol.
Infections such as any active infection (bacterial, viral, fungal, mycobacterial, parasitic or other), active Coronavirus disease (COVID-19) infection, uncontrolled infection with human immunodeficiency virus (HIV), hepatitis B virus (HBV), or hepatitis C virus (HCV), Cytomegalovirus (CMV) infection, as described in the protocol.

Sites

Inmunocel
Recruiting
Av. Pdte. Kennedy 5488, 7630716 Vitacura, Región Metropolitana, Chile
Clínica Alemana
Recruiting
Av. Vitacura 5951, Vitacura, Región Metropolitana, Santiago
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