Study Comparing Odronextamab and Chemotherapy with Rituximab and Chemotherapy for Untreated Diffuse Large B-cell Lymphoma

Sponsor: Regeneron Pharmaceuticals

Sponsor score: 60
Inactive

ClinicalTrials ID:NCT06091865

Provider View

This clinical trial is testing a new drug, odronextamab, combined with chemotherapy, against the standard treatment of rituximab and chemotherapy in patients with diffuse large B-cell lymphoma (DLBCL) who have not been treated before.

Patient Parameters

Program Overview

The study is exploring how well a new drug, odronextamab, works when combined with chemotherapy in patients with diffuse large B-cell lymphoma (DLBCL) who have not received any prior treatment. It also includes patients whose DLBCL has returned after treatment or did not respond to previous treatments. The study is divided into three parts: Part 1A and 1B focus on determining the safe dosage and schedule for odronextamab with chemotherapy. Part 2 compares the effectiveness of odronextamab with chemotherapy against the standard treatment of rituximab with chemotherapy. Researchers are also investigating potential side effects, how the drug is processed in the body, whether the body develops antibodies against it, and its impact on quality of life.

Eligibility Criteria

Inclusion Criteria

  • Patients who have not been treated for DLBCL before, or those with relapsed or refractory DLBCL (Part 1A only).
  • Must have measurable disease with at least one affected lymph node or other lesion.
  • Must be in relatively good health with an ECOG performance status of 2 or less.
  • Expected to live for at least 12 months.
  • For untreated DLBCL, must have an International Prognostic Index (IPI) score of 3 to 5 (Part 1) or 2 or more (Part 2).
  • Must have adequate blood and organ function.

Exclusion Criteria

  • Lymphoma affecting the brain or known brain involvement by non-primary CNS NHL.
  • Another active cancer or significant medical condition.
  • Severe nerve damage (Grade 3 or higher).
  • Previous treatment with systemic anti-lymphoma therapy, except for certain cases of relapsed/refractory DLBCL.
  • Any other treatment or investigational drug within 28 days or 5 half-lives of the drug before starting the study.
  • Recent major surgery, organ transplant, or standard radiotherapy.
  • Allergy or hypersensitivity to study drugs.
  • Active infections, including COVID-19, HIV, hepatitis B or C, or other serious infections.

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