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AzTrials

AMLPhase 1/2IDH1-AML-2024NCT06611839

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

A Phase 1/2 study testing Ivosidenib, Venetoclax, Azacitidine in people with AML and IDH1 Mutation, run by Institute of Hematology & Blood Diseases Hospital, China at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 14 years and older
Conditions the study is for
AML, IDH1 Mutation, Treatment
What is being tested?
Ivosidenib, Venetoclax, Azacitidine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
23 participants
Where
1 siteChina
Study dates
17 Oct 2025to 1 Oct 2028
Phase
Phase 1/2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 14 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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);
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  • 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.

Who cannot join

  • 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).
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  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Hui Wei, MD contact

13132507161

weihui@ihcams.ac.cn

China1 site, 1 recruiting

  • Blood Diseases Hospital

    Tianjin, Tianjin Municipality, 300020

    Hui Wei, MD, 86-13132507161, weihui@ihcams.ac.cn

    Recruiting

Other trials in China

About this study

Official title: A Multicenter, Single-Arm Clinical Study of the Venetoclax, Ivosidenib, and Azacitidine Triple-Drug Regimen in the Treatment of Chemotherapy-eligible Adult Patients With IDH1-Mutated Acute Myeloid Leukemia.

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.

Being tested
Ivosidenib, Venetoclax, Azacitidine

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Ivosidenib, Venetoclax, AzacitidineDrug

    Induction therapy：Ivosidenib 500mg d1-28 Venetoclax 100mg d1，200mg d2，400mg d3, 800mg d4-14 Azacitidine 75mg/m2/d, d1-7 .

    Consolidation therapy:

    intermediate-dose cytarabine regimen ： 3 courses If IDH1 mutant residual disease was positive before consolidation chemotherapy, Ivosidenib was added;

    Maintenance treatment:

    Azacitidine、Venetoclax 、Ivosidenib： 6 courses

Study groups in NCT06611839
Study groupRoleWhat they receive
Venetoclax、Ivosidenib and AzacitidineExperimentalInduction regimen includes venetoclax, ivosidenib and azacitidine followed by consolidation therapy with intermediate dose of cytarabine.
Receives: Drug: Ivosidenib, Venetoclax, Azacitidine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. CRc rate

    The ratio of patients achieved CR/CRh/CRi.

    Measured: Efficacy was assessed at least 2 weeks after completion of the first course of induction therapy.

  2. CRc MRD negtive rate by flow cytometry

    The CRc MRD negtive rate was detected by flow cytometry after induction, consolidation and maintenance therapy.

    Measured: Efficacy was assessed at least 2 weeks after completion of the first course of induction therapy.

  3. CRc MRD negtive rate by PCR

    The CRc MRD negtive rate was detected by PCR after induction, consolidation and maintenance therapy.

    Measured: Efficacy was assessed at least 2 weeks after completion of the first course of induction therapy.

  4. The maximum tolerated dose of ivosidenib and venetoclax combined with intensive chemotherapy

    To determine the maximum tolerated dose of ivosidenib and venetoclax combined with intensive chemotherapy

    Measured: up to 3 months after enrollment of the first participants

Secondary outcomes (5)

  1. Event-free survival (EFS)

    The interval from the date of enrollment to the date of failed to achieve complete remission, the date of relapse, or the date of death, whichever occurred first.

    Measured: up to 2 years after the date of the last enrolled participants

  2. overall survival

    The interval from the date of enrollment to the date of death or the date of last follow-up, whichever occurred first.

    Measured: up to 2 years after the date of the last enrolled participants

  3. Relapse free survival

    The interval from CR to the date of relapse, or the date of death, or the date of last follow-up, whichever occurred first.

    Measured: up to 2 years after the date of the last enrolled participants

  4. 30-day mortality

    Percentage of patients who died within 30 days from enrollment

    Measured: Within 30 days of the date of the last enrolled participants

  5. 60-day mortality

    Percentage of patients who died within 60 days from enrollment

    Measured: Within 60 days of the date of the last enrolled participants

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Sep 2024
  2. Study start17 Oct 2025
  3. Primary completion1 Oct 2026 (estimated)
  4. Study completion1 Oct 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
23 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06611839
Sponsor's protocol ID
IIT2024067
Acronym
IDH1-AML-2024
Status last verified
May 2026
First submitted
19 Sep 2024
Last updated
13 May 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Ivosidenib, Venetoclax, Azacitidine in people with AML and IDH1 Mutation, run by Institute of Hematology & Blood Diseases Hospital, China at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 13 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Hui Wei, MD (13132507161, weihui@ihcams.ac.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

CRc rate (time frame: Efficacy was assessed at least 2 weeks after completion of the first course of induction therapy.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06611839.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2026.

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