Venetoclax and Ivosidenib Combined With Chemotherapy in IDH1 Mutated AML

Launched by INSTITUTE OF HEMATOLOGY & BLOOD DISEASES HOSPITAL, CHINA · Sep 22, 2024

Keywords

ClinConnect Summary

This clinical trial is investigating a new treatment approach for patients with acute myeloid leukemia (AML) who have a specific genetic mutation called IDH1. The researchers want to see how well a combination of two medications, venetoclax and ivosidenib, works when used alongside chemotherapy. This study is especially important because current treatments for AML can be limited, and there is a need for more effective options. The trial aims to find the highest safe dose of the new combination and to measure how many patients respond positively to the treatment.

To participate in this trial, individuals must be at least 14 years old and have been diagnosed with AML that has the IDH1 mutation. They also need to meet certain health criteria, such as having acceptable levels of liver and kidney function. Participants will receive the new treatment in a clinical setting and will be closely monitored for any side effects or changes in their condition. If you're considering this trial, it's a chance to access a potentially promising treatment while contributing to important medical research.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Patients who meet AML according to WHO (2022) or AML and MDS/AML defined by ICC standards with IDH1 mutations detected by PCR or second-generation sequencing.
• • 2. Age ≥14 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 \>50% by measure of echocardiogram (ECHO) Informed consent must be signed before the commencement of all specific study procedures, and is signed by the patient himself or his immediate family. Considering the patient\'s condition, if the patient\'s signature is not conducive to the treatment of the condition, the informed consent shall be signed by the legal guardian or the patient\'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 RUNX1-RUNX1T1 or CBFB-MYH11 fusion gene
• • 3. Acute myeloid leukemia with BCR-ABL fusion gene
• • 4. Treated patients (but can receive hydroxyurea or cytarabine to lower tumor burden).
• • 5. Concurrent malignant tumors of other organs (those requiring treatment).
• 6. 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);
• • 7. Serious infectious diseases (uncured tuberculosis, pulmonary aspergillosis).
• • 8. Those who were not considered suitable for inclusion by the researchers.