Status:
NOT_YET_RECRUITING
Venetoclax in Combination With Ivosidenib and Azacitidine for Newly Diagnosed IDH1-Mutated AML
Lead Sponsor:
Institute of Hematology & Blood Diseases Hospital, China
Conditions:
AML
IDH1 Mutation
Eligibility:
All Genders
14+ years
Phase:
PHASE1
PHASE2
Brief Summary
Venetoclax can bind to the BCL-2 protein, thereby initiating the apoptosis program and exerting anti-AML effects. The induction regimen combining venetoclax with hypomethylating agents (HMA) significa...
Eligibility Criteria
Inclusion
- 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.
- Age ≥14 years old, male or female.
- The physical status assessment (ECOG-PS) of the Eastern Oncology Collaboration group was 0-2 points.
- Fulfill the requirements of the following laboratory tests (performed within 7 days prior to treatment) :
- Total bilirubin ≤ 1.5 times the upper limit of normal value (same age);
- AST and ALT≤ 2.5 times the upper limit of normal value (same age);
- Blood creatinine \< 2 times the upper limit of normal (same age);
- Myocardial enzymes \< 2 times the upper limit of normal (same age);
- 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
- Subjects who meet any of the following criteria are excluded from the study:
- Acute promyelocytic leukemia with PML-RARA fusion gene
- Acute myeloid leukemia with RUNX1-RUNX1T1 or CBFB-MYH11 fusion gene
- Acute myeloid leukemia with BCR-ABL fusion gene
- Treated patients (but can receive hydroxyurea or cytarabine to lower tumor burden).
- Concurrent malignant tumors of other organs (those requiring treatment).
- Active heart disease, defined as one or more of the following:
- A history of uncontrolled or symptomatic angina;
- Myocardial infarction less than 6 months after enrollment;
- Have a history of arrhythmia requiring drug treatment or severe clinical symptoms;
- Uncontrolled or symptomatic congestive heart failure (\> NYHA level 2);
- Serious infectious diseases (uncured tuberculosis, pulmonary aspergillosis).
- Those who were not considered suitable for inclusion by the researchers.
Key Trial Info
Start Date :
October 30 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2028
Estimated Enrollment :
29 Patients enrolled
Trial Details
Trial ID
NCT06611839
Start Date
October 30 2025
End Date
October 1 2028
Last Update
September 19 2025
Active Locations (0)
Enter a location and click search to find clinical trials sorted by distance.
No Results Found
We couldn’t find results for the location/zipcode entered or within the selected range. Please check your input or adjust your search.