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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

NCT06091865 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 904

Last updated 2026-05-15

No results posted yet for this 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

Conditions

  • Diffuse Large B-cell Lymphoma (DLBCL)

Interventions

DRUG

Odronextamab

Odronextamab will be administered by intravenous (IV) infusion

DRUG

Rituximab

Rituximab will be administered IV, or subcutaneously (SC)

DRUG

Cyclophosphamide

Cyclophosphamide will be administered IV as part of chemotherapy

DRUG

Doxorubicin

Doxorubicin will be administered IV as part of chemotherapy

DRUG

Vincristine

Vincristine will be administered IV as part of chemotherapy

DRUG

Prednisone/Prednisolone

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

Sponsors & Collaborators

Principal Investigators

  • Clinical Trial Management · Regeneron Pharmaceuticals

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-12-13
Primary Completion
2028-03-30
Completion
2029-09-12
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Austria
  • Belgium
  • Chile
  • Czechia
  • France
  • Germany
  • Ireland
  • Israel
  • Italy
  • Malaysia
  • Poland
  • Singapore
  • South Korea
  • Spain
  • Taiwan
  • Thailand
  • Turkey (Türkiye)
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06091865 on ClinicalTrials.gov