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RECRUITING
NCT05522192
PHASE1/PHASE2

Clinical Study of Mitoxantrone Hydrochloride Liposome Injection in Subjects With Acute Myeloid Leukemia

Sponsor: Hui Zeng

View on ClinicalTrials.gov

Summary

This study is an open-label, single-arm, phase I/II clinical study. Phase I is a multi-center, dose-escalation study, aiming to explore the maximum tolerated dose (MTD) of venetoclax combined with mitoxantrone liposome in the treatment of relapsed or refractory acute myeloid leukemia (AML), and determine the recommended dose for phase II (RP2D); Phase II is a multi-center, exploratory study, aiming to explore efficacy of venetoclax combined with mitoxantrone liposome in the treatment of relapsed and refractory AML patients, and to explore the differences in the efficacy of this combination therapy with different gene mutations.

Official title: Clinical Study of Venetoclax Combined With Mitoxantrone Liposome in the Treatment of Relapsed or Refractory Acute Myeloid Leukemia

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

70

Start Date

2022-07-21

Completion Date

2026-05

Last Updated

2022-08-30

Healthy Volunteers

No

Interventions

DRUG

Mitoxantrone liposome

Phase I: 24mg/m2, 30 mg/m2, 36mg/m2, IV, d1; Phase II: RP2D.

DRUG

Venetoclax

Phase I/II: 100mg po d1,200mg po d2,400mg po d3-28.

Locations (1)

First Affiliated Hospital of Jinan University

Guangzhou, Guangdong, China