NCT05777369

R-CMOP in Patients With Primary Diffuse Large B-cell Lymphoma

An Open, Single-arm, Multicenter Study of R-CMOP Protocol for Primary Treatment of Diffuse Large B-cell Lymphoma Based on Cardiac Function Screening

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: The First Affiliated Hospital with Nanjing Medical University · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

To evaluate the efficacy and safety of R-CMOP regimen based on mitoxantrone hydrochloride liposome injection in the treatment of newly diagnosed diffuse large B-cell lymphoma (DLBCL) based on cardiac function screening

Detailed description

Compared with traditional mitoxantrone, mitoxantrone liposomes can significantly prolong the survival time of patients and reduce the cardiotoxicity and non-hematological toxicity of anthracycline drugs. Based on the cardiac safety and efficacy of mitoxantrone liposome, the R-CMOP scheme based on Mitoxantrone liposome for the treatment of initial DLBCL based on cardiac function screening has sufficient theoretical basis and is worth exploring.

Conditions

• Diffuse Large B-cell Lymphoma

Interventions

Type	Name	Description
DRUG	Rituximab	375 mg/m2, d0
DRUG	Mitoxantrone hydrochloride liposome	18 mg/m2, d1
DRUG	Cyclophosphamide	750 mg/m2, d1
DRUG	Vincristine/Vindesine	Vincristine: 1.4 mg/m2, d1(The maximum dose was 2 mg) Vindesine: 3 mg/m2, d1
DRUG	Prednisone	60 mg/m2, d1\~d5

Timeline

• Start date: 2023-03-01
• Primary completion: 2023-08-01
• Completion: 2024-08-01
• First posted: 2023-03-21
• Last updated: 2023-03-21