Combining Venetoclax with Intensive Chemotherapy for Acute Myeloid Leukemia

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 clinical trial investigates the effectiveness of combining Venetoclax with intensive chemotherapy in adult patients with Acute Myeloid Leukemia (AML). The study aims to determine which genetic subgroups of AML patients benefit most from this combination treatment. Participants will receive one course of intensive chemotherapy with Venetoclax, followed by additional courses based on their response. The trial will also explore maintenance therapy with Venetoclax and azacitidine after consolidation treatment.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Patients who meet AML according to WHO (2022) or AML and MDS/AML defined by ICC standards.
2. Age ≥14 years old, ≤ 60 years old, male or female.
3. The physical status assessment (ECOG-PS) of the Eastern Oncology Collaboration group was 0-2 points.
4. Fulfill the requirements of the following laboratory tests (performed within 7 days prior to treatment) :

   1. Total bilirubin ≤ 1.5 times the upper limit of normal value (same age);
   2. AST and ALT≤ 2.5 times the upper limit of normal value (same age);
   3. Blood creatinine \< 2 times the upper limit of normal (same age);
   4. Myocardial enzymes \< 2 times the upper limit of normal (same age);
   5. Left ventricular ejection fraction \&gt;50% by measure of echocardiogram (ECHO). Informed consent must be signed before the commencement of all specific study procedures, and signed by the patient himself or his immediate family. Considering the patient\&#39;s condition, if the patient\&#39;s signature is not conducive to the treatment of the condition, the informed consent shall be signed by the legal guardian or the patient\&#39;s immediate family.

Exclusion Criteria:

Subjects who meet any of the following criteria are excluded from the study:

1. Acute promyelocytic leukemia with PML-RARA fusion gene
2. Acute myeloid leukemia with BCR-ABL fusion gene
3. Treated patients (but can receive hydroxyurea or cytarabine to the lower tumor burden).
4. Concurrent malignant tumors of other organs (those requiring treatment).
5. Active heart disease, defined as one or more of the following:

   1. A history of uncontrolled or symptomatic angina;
   2. Myocardial infarction less than 6 months after enrollment;
   3. Have a history of arrhythmia requiring drug treatment or severe clinical symptoms;
   4. Uncontrolled or symptomatic congestive heart failure (\> NYHA level 2);
6. Serious infectious diseases (uncured tuberculosis, pulmonary aspergillosis).
7. Those who were not considered suitable for inclusion by the researchers.

Where it's running

• Blood Diseases Hospital
  Tianjin, Tianjin Municipality, China Recruiting

Study contacts

• Principal investigator: Hui Wei, MD — Blood Diseases Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College
• 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.