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 (OLYMPIA-3)
Diffuse Large B-cell Lymphoma (DLBCL)
About this trial
This is an interventional treatment trial for Diffuse Large B-cell Lymphoma (DLBCL) focused on measuring Non-Hodgkin lymphomas (NHL), B-cell non-Hodgkin lymphomas (B-NHL), Diffuse Large B-cell Lymphoma, Odronextamab, Anti-CD20 × anti-CD3 bispecific antibody
Eligibility Criteria
KEY Inclusion Criteria: 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. KEY Exclusion Criteria: 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. Note: Other protocol-defined Inclusion/ Exclusion criteria apply
Sites / Locations
- Clinical Research Alliance IncRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
Odronextamab + CHOP
Rituximab + CHOP
Part 1, includes dose escalation (Part 1A), and randomized exploration of 2 regimens of odronextamab -cyclophosphamide, doxorubicin, vincristine, prednisone (O-CHOP) dose optimization, (Part 1B).
Part 2 is the randomized controlled portion, participants will receive either O-CHOP or R-CHOP.