NCT06045247

Phase 2 Trial of Epcoritamab in Combination With Rituximab-mini CVP for Older Unfit/Frail Patients or Anthracycline-Ineligible Adult Patients With Newly Diagnosed Diffuse Large B-cell Lymphoma

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

To learn if adding epcoritamab to the treatment combination R-miniCVP (rituximab, cyclophosphamide, vincristine, prednisone) can help to control newly diagnosed DLBCL. The safety of this combination will also be studied.

Detailed description

Primary Objectives: --To determine the efficacy of epcoritamab in combination with R-miniCVP as determined by CR rate after six cycles of combination treatment for elderly/unfit patients or patients with heart failure with previously untreated DLBCL. Secondary Objectives --To determine best overall response rate (ORR), duration of response, progression-free survival (PFS), overall survival (OS), and evaluation of safety of epcoritamab in combination with R-miniCVP as treatment for elderly/unfit patients or patients with heart failure with previously untreated DLBCL. Exploratory Objectives: * To determine the biomarkers of response and mechanisms of resistance to epcoritamab in combination with R-miniCVP in DLBCL. * To determine the quality of life in patients with DLBCL receiving epcoritamab in combination with R-miniCVP

Conditions

• Large B-cell Lymphoma

Interventions

Type	Name	Description
DRUG	Prednisone	Given by IV (vein)
DRUG	Rituximab	Given by IV (vein)
DRUG	Cyclophosphamide	Given by IV (vein)
DRUG	Vincristine	Given by IV (vein)
DRUG	Epcoritamab	Given under the skin

Timeline

• Start date: 2024-01-05
• Primary completion: 2028-07-31
• Completion: 2030-07-31
• First posted: 2023-09-21
• Last updated: 2026-02-27

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study