Venetoclax, Azacitidine and Liposomal Mitoxantrone for Newly Diagnosed AML

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a single-arm, open-label trial enrolling adults and some adolescents with newly diagnosed AML. Participants receive a induction regimen of Venetoclax, Azacitidine, and Liposomal Mitoxantrone (VAM) followed by three cycles of intermediate-dose cytarabine for consolidation. Allogeneic stem cell transplantation is recommended for those in remission who are high-risk or have measurable residual disease. The study aims to assess safety and preliminary efficacy to inform future research directions. Enrollment targets 27 patients at a single center in Tianjin, China.

Why it matters

Who can join: the full rules

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.

Where it's running

• Blood diseases hospital
  Tianjin, Tianjin Municipality, China Recruiting

Study contacts

• Study coordinator: Hui Wei, MD
• Email: weihui@ihcams.ac.cn
• Phone: 13132507161

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.