Non-Hodgkin's Lymphoma Clinical Trial
Official title:
A Phase 1/2 Study of Mitoxantrone Hydrochloride Liposome Infusion in Patients With Non-Hodgkin's Lymphoma
This is a Phase 1/2, open-label, multicenter study.
The Phase 1 part of this study is designed to identify the MTD and RP2D, and to characterize
the safety, tolerability, and PK. The Phase 1 part of the study will include 2 parts: dose
escalation and dose expansion.
After confirmation of the RP2D in the expansion part of Phase 1, enrolment into the Phase 2
part of the study will begin. The primary objective of the Phase 2 part of the study is to
evaluate the efficacy of the investigational drug when administered to patients with
relapsed or refractory NHL.
;
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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|---|---|---|---|
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