NCT06594640

R-CMOP in Patients With Newly Diagnosed Diffuse Large B-cell Lymphoma

A Multicenter, Prospective Phase I/II Trial to Evaluate the Safety and Efficacy of Mitoxantrone Hydrochloride Liposome in Combination With Cyclophosphamide, Vincristine, Prednisone, and Rituximab in Patients With Newly Diagnosed DLBCL

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 108 (estimated)
• Sponsor: Institute of Hematology & Blood Diseases Hospital, China · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a prospective clinical study to evaluate the safety and efficacy of R-CMOP in patients with newly diagnosed diffuse large B-cell lymphoma

Detailed description

This is an open, multicenter, prospective phase I/II clinical study to evaluate the safety and efficacy of mitoxantrone hydrochloride liposome injection in combination with cyclophosphamide, vincristine, prednisone, and rituximab (R-CMOP) in patients with newly diagnosed diffuse large B-cell lymphoma. The study is divided into two parts. The first part uses a 3+3 dose-escalation design, in which mitoxantrone hydrochloride liposome injection in the R-CMOP regimen will be administered at three different doses: 16 mg/m², 18 mg/m², and 20 mg/m², to determine the recommended Phase 2 dose (RP2D). The second part follows a single-arm design to evaluate the efficacy and safety of the R-CMOP regimen, with mitoxantrone hydrochloride liposome injection administered at the RP2D. Each cycle consists of 21 days. A maximum of 6 cycles of therapy are planned.

Conditions

• Diffuse Large B-cell Lymphoma

Interventions

Type	Name	Description
DRUG	Mitoxantrone Hydrochloride Liposome	assigned dose according to the 3+3 dose-escalation design in part 1, RP2D in part 2, D2
DRUG	Rituximab (R)	375mg/m2, D2
DRUG	Cyclophosphamide (CTX)	750mg/m2, D2
DRUG	Vincristin	1.2mg/m2, maximum 2mg， D2
DRUG	Prednisolone	60mg/m2, D2-6

Timeline

• Start date: 2024-05-30
• Primary completion: 2026-06-30
• Completion: 2027-07-30
• First posted: 2024-09-19
• Last updated: 2025-05-14

Locations

1 site across 1 country: China