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

Conditions

• Diffuse Large B-cell Lymphoma (DLBCL)

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Odronextamab — DRUG
  Odronextamab will be administered by intravenous (IV) infusion
• Rituximab — DRUG
  Rituximab will be administered IV, or subcutaneously (SC)
• Cyclophosphamide — DRUG
  Cyclophosphamide will be administered IV as part of chemotherapy
• Doxorubicin — DRUG
  Doxorubicin will be administered IV as part of chemotherapy
• Vincristine — DRUG
  Vincristine will be administered IV as part of chemotherapy
• Prednisone/Prednisolone — DRUG
  Prednisone or prednisolone will be administered orally (PO) as part of chemotherapy

Study Details

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

Key Dates

Start date

Dec 13, 2023

Status verified

May 2026

Primary completion

Mar 30, 2028

Completion

Sep 12, 2029

Study Design

Enrollment

904 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Odronextamab + CHOP
  Part 1, includes dose escalation (Part 1A), and randomized exploration of 2 regimens of odronextamab -cyclophosphamide, doxorubicin, vincristine, prednisone (Odro-CHOP) dose optimization (Part 1B).
• Active Comparator: Rituximab + CHOP
  Part 2 is the randomized controlled portion, participants will receive either Odro-CHOP or R-CHOP.

Primary Outcome Measure

Incidence of Dose Limiting Toxicities (DLTs) [ Time Frame: Up to 35 days ]

Central Contacts

• Clinical Trials Administrator
  844-734-6643
  [email protected]

Locations (20)

Find similar trials in Los Angeles, CA

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