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

Condition(s) studied

Investigational drug(s) / intervention(s)

Odronextamab: Odronextamab will be administered by intravenous (IV) infusion

Rituximab: Rituximab will be administered IV, or subcutaneously (SC)

Cyclophosphamide: Cyclophosphamide will be administered IV as part of chemotherapy

Doxorubicin: Doxorubicin will be administered IV as part of chemotherapy

Vincristine: Vincristine will be administered IV as part of chemotherapy

Prednisone/Prednisolone: Prednisone or prednisolone will be administered orally (PO) as part of chemotherapy

Study summary

This study is researching an experimental drug called odronextamab, referred to as study drug, when used in combination with chemotherapy. The study is focused on patients with Diffuse Large B-cell Lymphoma (DLBCL) that have not been treated before (called "previously untreated"). Patients with DLBCL that have come back after treatment (called "relapsed"), or have not responded to treatment (called "refractory"), can also participate in this study.

This study will be made up of Part 1A, Part 1B, and Part 2.The aim of Part 1A and Part 1B of the study is to see how safe and tolerable the study drug in combination with chemotherapy is and to determine the dose and schedule of the study drug to be combined with chemotherapy in Part 2 of the study.

The aim of Part 2 of the study is to see how effective the combination of the study drug with chemotherapy is in comparison with the combination of rituximab (the comparator drug), and chemotherapy, the current standard of care treatment approved for DLBCL. Standard of care means the usual medication expected and used when receiving treatment for a condition.

The study is looking at several other research questions, including:

* What side effects may happen from taking the study drug when combined with chemotherapy
* How much study drug is in the blood at different times
* Whether the body makes antibodies against the study drug (which could make the study drug less effective or could lead to side effects)
* The impact from the study drug on quality of life and ability to complete routine daily activities

Eligibility

Primary outcome measure(s)

• Incidence of Dose Limiting Toxicities (DLTs) — Up to 35 days
  Part 1A
• Incidence of Treatment Emergent Adverse Events (TEAEs) — Up to 2 years
  Part 1
• Severity of TEAEs — Up to 2 years
  Part 1
• Progression Free Survival (PFS), assessed by Independent Central Review (ICR) — Up to 5 years
  Part 2

Trial sites (185)

+ 145 more sites — see the full list on the official registry below.

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