Combining Venetoclax with Intensive Chemotherapy for Acute Myeloid Leukemia

Efficacy of Venetoclax Combined With Intensive Chemotherapy in Different Subgroups of Acute Myeloid Leukemia : a Multi-center, Single-arm Clinical Trial

This study is testing if adding Venetoclax to strong chemotherapy helps adults with Acute Myeloid Leukemia feel better and which genetic types benefit the most from this treatment.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 380 (estimated)
• Ages: 14 Years to 60 Years
• Sex: All
• Sponsor: Institute of Hematology & Blood Diseases Hospital, China (Academic / other)
• Drugs / interventions: chemotherapy
• Locations: 1 site (Tianjin, Tianjin Municipality)
• Trial ID: NCT06635681 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are adults aged 14 to 60 with a confirmed diagnosis of AML and an ECOG performance status of 0-2.

Not a fit: Patients with AML who do not meet the genetic criteria or those with severe comorbidities may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could improve remission rates and overall outcomes for patients with specific genetic subtypes of AML.

How similar studies have performed: Previous studies have shown promising results with Venetoclax in certain AML subgroups, indicating potential for success in this trial.

Eligibility criteria

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 this trial is running

Tianjin, Tianjin Municipality

• 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

Conditions AML