NCT05575973

Mitoxantrone Hydrochloride Liposome Combined With Rituximab and Lenalidomide (M+R2) in Patients With Relapsed and Refractory Diffuse Large B-Cell Lymphoma

A Prospective, Single-arm, Multicenter Clinical Study of Mitoxantrone Hydrochloride Liposome Combined With Rituximab and Lenalidomide in the Treatment of Relapsed and Refractory Diffuse Large B-cell Lymphoma

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 55 (estimated)
• Sponsor: Jianfeng Zhou · Academic / Other
• Sex: All
• Age: 60 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

To evaluate the safety and efficacy of mitoxantrone hydrochloride liposome in combination with rituximab and lenalidomide in the treatment of relapsed and refractory diffuse large B-cell lymphoma (DLBCL).

Detailed description

This is a prospective, single-arm, multicenter phase Ⅱ clinical study to evaluate the safety and efficacy of mitoxantrone hydrochloride liposome in combination with rituximab and lenalidomide in patients with relapsed and refractory diffuse large B-cell lymphoma (DLBCL). Mitoxantrone hydrochloride liposome will be given on day 1 at the dose of 20 mg/m2 and be combined with rituximab and lenalidomide. A maximum of 6 cycles of therapy are planned.

Conditions

• Diffuse Large B-cell Lymphoma

Interventions

Type	Name	Description
DRUG	Mitoxantrone Hydrochloride Liposome	Drug: Mitoxantrone hydrochloride liposome (20 mg/m2) will be administered by an intravenous infusion on day 1 of each 28-day cycle.
DRUG	Rituximab	Drug: Rituximab (375 mg/m2) will be administered by an intravenous infusion on day 1 of each 28-day cycle.
DRUG	Lenalidomide	Drug: Lenalidomide (25 mg) will be taken orally from day 1 to day 8 of each 28-day cycle.

Timeline

• Start date: 2022-10-10
• Primary completion: 2025-07-01
• Completion: 2025-10-01
• First posted: 2022-10-12
• Last updated: 2022-10-12

Locations

1 site across 1 country: China