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RECRUITING
NCT06594640
PHASE1/PHASE2

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

Sponsor: Institute of Hematology & Blood Diseases Hospital, China

View on ClinicalTrials.gov

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

Official title: 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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

108

Start Date

2024-05-30

Completion Date

2027-07-30

Last Updated

2025-05-14

Healthy Volunteers

No

Interventions

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

Locations (1)

Institute of Hematology & Blood Disease Hospital

Tianjin, Tianjin Municipality, China