Venetoclax in Combination With Ivosidenib and Azacitidine for Newly Diagnosed IDH1-Mutated AML

Plain-language summary

This study evaluates the safety and effect of Venetoclax combined with Ivosidenib and Azacitidine in newly diagnosed patients with IDH1-mutated acute myeloid leukemia (AML). Patients aged 14 and older with a confirmed IDH1 mutation can take part. It is being conducted in Phase 1/Phase 2 and is still enrolling participants.

The summary above is a plain-language rendering of the official record. The original English title is shown for reference.

Trial details

Phase

PHASE1/PHASE2

Status

Recruiting

Sponsor

Institute of Hematology & Blood Diseases Hospital, China

Intervention

Ivosidenib, Venetoclax, Azacitidine

Start date

10/17/2025

Estimated completion

10/1/2028

Countries

China

Related genes

Locations

• Tianjin, China

Eligibility criteria

Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.

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.