Efficacy of Venetoclax Combined with Intensive Chemotherapy in Different Subgroups of AML

Launched by INSTITUTE OF HEMATOLOGY & BLOOD DISEASES HOSPITAL, CHINA · Oct 8, 2024

Keywords

ClinConnect Summary

This clinical trial is looking at how well a medication called Venetoclax works when combined with intensive chemotherapy for patients with Acute Myelogenous Leukemia (AML). AML is a type of cancer that affects the blood and bone marrow, and this study aims to find out which specific groups of patients might benefit most from this combination treatment, based on their genetic makeup. The research is specifically focusing on adults aged 14 to 60 years who are physically fit enough to undergo intensive chemotherapy.

To be eligible for this trial, participants must have a confirmed diagnosis of AML and meet certain health criteria, such as having stable blood tests and good heart function. Those who have specific types of leukemia or other serious health conditions may not be able to participate. If enrolled, participants can expect to receive a combination of Venetoclax and chemotherapy and will be monitored closely throughout the study to assess how well the treatment is working. This trial is currently recruiting, and patients or their families can discuss participation with their healthcare team to learn more about the potential benefits and risks.

Gender

ALL

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.