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

Sponsor
Hui Zeng
Study ID
NCT05522192
Phase
PHASE1/PHASE2
Status
Unknown

Conditions

  • Relapsed or Refractory Acute Myeloid Leukemia

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Mitoxantrone liposome — DRUG
    Phase I: 24mg/m2, 30 mg/m2, 36mg/m2, IV, d1; Phase II: RP2D.
  • Venetoclax — DRUG
    Phase I/II: 100mg po d1，200mg po d2，400mg po d3-28.

Study Details

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.

Key Dates

Start date
Jul 21, 2022
Status verified
Aug 2022
Primary completion
Nov 30, 2025
Completion
May 31, 2026

Study Design

Enrollment
70 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Venetoclax-Mitoxantrone liposome
    Phase I Mitoxantrone liposome * Level 1: 24mg/m\^2, ivgtt, d1; * Level 2: 30mg/m\^2, ivgtt, d1; * Level 3: 36mg/m\^2, ivgtt, d1; Venetoclax: 100mg po d1, 200mg po d2, 400mg po d3-28. Every 4 weeks is a cycle, a total of 2 cycles, the first cycle to observe DLT. Phase II Mitoxantrone liposome: RP2D Venetoclax: 100mg po d1, 200mg po d2, 400mg po d3-28. 28 days is a cycle, and a maximum of 6 cycles can be carried out. If the patient achieves CR, CRi or PR, if the patient can tolerate it, it will be used for 6 cycles; if the patient is suitable for transplantation, it can also enter the transplantation path; If the patient was evaluated as NR (no response) after 2 cycles, he could withdraw from the study.

Primary Outcome Measure

Phase I: MTD of mitoxantrone liposomes [ Time Frame: At the end of Cycle 1 (each cycle is 28 days) ]

Central Contacts