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Recruiting NCT07490288

Venetoclax, Azacitidine and Liposomal Mitoxantrone for Newly Diagnosed AML

No phase Interventional AML

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Venetoclax, Azacitidine, Liposomal Mitoxantrone, Cytarabine.
Who it may be relevant to
Registry conditions: AML. Basic parameters: 14 years — 100 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

A Single-Arm, Open-Label Study of Venetoclax, Azacitidine, and Liposomal Mitoxantrone (VAM) as Induction Therapy in Newly-diagnosed Adult Patients With Acute Myeloid Leukemia (AML)

Overview

This is a single-arm, open-label clinical trial evaluating the safety and preliminary efficacy of a novel induction regimen combining Venetoclax, Azacitidine, and Liposomal Mitoxantrone (VAM) in patients with newly diagnosed Acute Myeloid Leukemia (AML) who are eligible for intensive chemotherapy. The study plans to enroll 27 participants. Patients will receive VAM induction therapy, followed by three cycles of intermediate-dose cytarabine consolidation. Allogeneic hematopoietic stem cell transplantation is recommended for high-risk or MRD-positive patients in remission.

Interventions

  • Drug Venetoclax
    BCL-2 inhibitor. Oral. Induction: 100 mg day 1, 200 mg day 2, then 400 mg days 3-14.
  • Drug Azacitidine
    Hypomethylating agent. 75 mg/m²/day IV/SC on days 1-7 of induction.
  • Drug Liposomal Mitoxantrone
    Liposomal topoisomerase II inhibitor. 24 mg/m² IV on day 1 of each induction cycle.
  • Drug Cytarabine
    Antimetabolite. Consolidation: 2 g/m² (age \<60) or 1 g/m² (age ≥60) q12h IV on days 1-3 for 3 cycles.
  • Procedure Allogeneic Hematopoietic Stem Cell Transplantation (HSCT)
    Recommended for high-risk or MRD+ patients after response.

Primary outcome measures

  • complete remission rate after induction [Time frame: up to 84 days]
Secondary outcome measures (9)
  • Event-free survival [Time frame: Up to 2 years]
  • Overall survival [Time frame: Up to 5 years]
  • Relapse-free survival [Time frame: Up to 5 years]
  • MRD negativity rate by flow cytometry after 1 induction cycle [Time frame: At the end of the first and second induction cycles]
  • MRD negativity rate by flow cytometry after 2 induction cycles [Time frame: At the end of the first and second induction cycles]
  • 30-day mortality [Time frame: up to 30 days]
  • 60-day mortality [Time frame: up to 60 days]
  • MRD negativity rate by NGS OR PCR after 1 induction cycle [Time frame: up to 42 days]
  • MRD negativity rate by NGS OR PCR after 2 induction cycles [Time frame: up to 84 days]

Eligibility criteria

Inclusion criteria

  • Patients diagnosed with AML according to the WHO (2022) or ICC criteria, or with MDS/AML as defined by ICC (with 10%-20% blasts in the bone marrow)
  • Age ≥ 14 years, male or female.
  • Eastern Cooperative Oncology Group Performance Status (ECOG-PS) score of 0-2.
  • Meet the following laboratory requirements (tests must be performed within 7 days prior to treatment):

i. Total bilirubin ≤ 1.5 times the upper limit of normal (ULN) for the corresponding age group.

ii. AST and ALT ≤ 2.5 times ULN for the corresponding age group. iii. Serum creatinine < 1.5 times ULN for the corresponding age group. iv. Cardiac enzymes < 2 times ULN for the corresponding age group. v. Left ventricular ejection fraction (LVEF) within the normal range as measured by echocardiography (ECHO).

Exclusion criteria

  • Acute promyelocytic leukemia with PML::RARA fusion gene.
  • Acute myeloid leukemia with RUNX1::RUNX1T1 fusion gene.
  • Acute myeloid leukemia with BCR::ABL1 fusion gene.
  • Previously treated patients (defined as having received prior induction chemotherapy for AML/MDS; prior use of cytoreductive agents like hydroxyurea is allowed).
  • Concurrent active malignancy of other organs (requiring treatment).
  • Active cardiac disease, defined as one or more of the following:

i. History of uncontrolled or symptomatic angina. ii. Myocardial infarction within 6 months prior to study enrollment. iii. History of clinically significant arrhythmia requiring medication or causing severe symptoms.

iv. Uncontrolled or symptomatic congestive heart failure (> New York Heart Association \[NYHA\] Class 2).

  • Active, uncontrolled infectious diseases (e.g., untreated tuberculosis, pulmonary aspergillosis).
  • Any other condition that, in the opinion of the investigator, makes the patient unsuitable for study participation.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

China · 1 center
  • Blood diseases hospital — Tianjin

Identifiers

NCT: NCT07490288 · IIT2026021

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗