NCT06611839 Venetoclax in Combination With Ivosidenib and Azacitidine for Newly Diagnosed IDH1-Mutated AML
| NCT ID | NCT06611839 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | Institute of Hematology & Blood Diseases Hospital, China |
| Condition | AML |
| Study Type | INTERVENTIONAL |
| Enrollment | 23 participants |
| Start Date | 2025-10-17 |
| Primary Completion | 2026-10-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 23 participants in total. It began in 2025-10-17 with a primary completion date of 2026-10-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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) significantly improves the remission rate (over 60%) in elderly unfit AML patients and markedly prolongs survival in those achieving complete remission. Isocitrate dehydrogenase (IDH) 1 and 2 are involved in the citric acid cycle. Approximately 20% of AML patients carry IDH1 or IDH2 mutations, which lead to the reduction of α-ketoglutarate to 2-hydroxyglutarate (2-HG). 2-HG can cause histone methylation and inhibit TET2 activity, resulting in DNA hypermethylation, thereby affecting gene expression and cell differentiation. IDH mutations are more common in elderly patients and are often associated with cytogenetic abnormalities; they may also co-occur with FLT3-ITD, NPM1, or DNMT3A mutations. Ivosidenib is an IDH1 inhibitor, and previous studies have confirmed its safety and efficacy in AML treatment. According to adult AML treatment guidelines, IDH-mutated patients eligible for intensive chemotherapy may receive IDH inhibitors during induction therapy. Based on the study by Montesinos et al. on the role of ivosidenib and azacitidine in IDH-mutated AML, for patients ineligible for intensive chemotherapy, a new treatment option has been added: IDH1-mutated AML patients may receive ivosidenib (500 mg, days 1-28) combined with azacitidine (75 mg/m²/day for 7 days) in 28-day cycles, or ivosidenib monotherapy. Recent studies have shown that a triple-drug regimen comprising ivosidenib, venetoclax, and azacitidine demonstrates excellent efficacy and safety. In chemotherapy-ineligible patients, the triple regimen achieved a composite complete remission rate (CRc) of 86% and an overall response rate (ORR) of 92%. At a median follow-up of 27.4 months, the 2-year overall survival (OS) was 72%, and the 2-year event-free survival (EFS) was 72%. Therefore, this study aims to conduct a multicenter, single-arm clinical trial to preliminarily evaluate the long-term efficacy of this combination in adult AML.
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.
Contact & Investigator
Hui Wei, MD
PRINCIPAL INVESTIGATOR
Blood diseases hospital
Frequently Asked Questions
Who can join the NCT06611839 clinical trial?
This trial is open to participants of all sexes, aged 14 Years or older, studying AML. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06611839 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06611839 currently recruiting?
Yes, NCT06611839 is actively recruiting participants. Contact the research team at weihui@ihcams.ac.cn for enrollment information.
Where is the NCT06611839 trial being conducted?
This trial is being conducted at Tianjin, China.
Who is sponsoring the NCT06611839 clinical trial?
NCT06611839 is sponsored by Institute of Hematology & Blood Diseases Hospital, China. The principal investigator is Hui Wei, MD at Blood diseases hospital. The trial plans to enroll 23 participants.