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Study of Ivosidenib, Azacitidine, and Venetoclax for AML with IDH1 Mutation

This study is looking at a new treatment approach for people with newly diagnosed acute myeloid leukemia (AML) that has an IDH1 mutation. Researchers are testing a combination of three drugs: ivosidenib, azacitidine, and venetoclax. After this initial treatment, participants will continue with ivosidenib alone as maintenance therapy (additional treatment to help prevent cancer from returning). The main goal is to see how long people live without their disease getting worse (event-free survival) at 12 months. To join, you must be at least 60 years old and have newly diagnosed AML with an IDH1 mutation. The study plans to enroll 45 participants, but its current status is unclear.

Study design
This study is an interventional study with a planned enrollment of 45 participants. The phase of the study is not specified.
What's involved
Ivosidenib is given on days 15-28 for the first cycle, then days 1-28 for subsequent cycles. Azacitidine is given on days 1-7, and Venetoclax is given on days 1-14.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint, event-free survival, is measured at 12 months.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07392242

A Study of the Combination of Ivosidenib, Azacitidine, and Venetoclax Followed by Ivosidenib Alone in People With Acute Myeloid Leukemia

Recruiting
PHASE2Ages 60+InterventionalTreatment
Memorial Sloan Kettering Cancer Center
~45 participants
Updated 2026-07-17 on ClinicalTrials.gov
What's tested:IvosidenibAzacitidineVenetoclax

At a glance

Recruiting sites
7 of 7 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Event free survival
Measured over 12 months

Conditions

Acute Myeloid Leukemia

Explore related trials

Acute Myeloid LeukemiaIDH1 Gene

Where it's being run

7 sites across 2 states
New York4
New Jersey3

Study leadership

  • Kuo-Kai Chin, MD · PRINCIPAL_INVESTIGATOR · Memorial Sloan Kettering Cancer Center

Who to contact

Kuo-Kai Chin, MD
[email protected]
646-608-4415
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Participant must be at least 60 years of age at the time of signing the informed consent form (ICF).
Participant is willing and able to adhere to the study visit schedule and other protocol requirements.
Participant has newly diagnosed AML as per World Health Organization 2022 or European leukemia Network 2022 guidelines.
Participant has IDH1-R132 mutation present prior to initiating Ivo/Aza/Ven confirmed by CLIA approved local testing via next-generation sequencing (NGS) and/or polymerase chain reaction (PCR). Other 2-HG producing IDH1 variants may be eligible after discussion with MSK principal investigator.
Participant has Eastern Cooperative Oncology Group (ECOG) performance status of 0-3
Participant must have a WBC count \<25,000/μL at the time of initiation of study drug (leukapheresis may be performed and/or hydroxyurea may be administered to decrease the WBC count to \<25,000/μL).
Participant has adequate organ function defined as:

Exclusion

Participant with acute promyelocytic leukemia
Participants who have previously received ivosidenib or venetoclax
Participant receiving any other investigational anti-cancer agents. Cytoreductive therapy such as hydroxyurea is permitted.
Participants with immediate life-threatening, severe complications of leukemia such as uncontrolled bleeding, pneumonia with hypoxia or shock, and/or disseminated intravascular coagulation
Participant has active uncontrolled systemic fungal, bacterial, or viral infection (defined as ongoing signs/symptoms related to the infection without improvement despite appropriate antibiotics, antiviral therapy, and/or other treatment).
Participants who are planned for allogeneic stem cell transplantation based on the assessment of the treating clinician.
Participant has significant active cardiac disease within 6 months prior to start of study treatment, including New York Heart Association (NYHA) class III or IV congestive heart failure; acute coronary syndrome (ACS); and/or stroke
Participant is known to have dysphagia, short-gut syndrome, gastroparesis, or other conditions that limit the ingestion or gastrointestinal absorption of drugs administered orally.
Participant has QTc interval (i.e., Fridericia's correction \[QTcF\]) ≥ 450 ms (mean of triplicate ECG) or other factors that increase the risk of QT prolongation or ventricular arrhythmic events (e.g. family history of long QT interval syndrome). Participants with a QTcF over 450 ms due
Male or female participants not willing to comply with contraceptive requirements

What this trial measures

  • Event free survival12 months

    Event-free survival is defined as the time between date of treatment start to treatment failure (failure to achieve complete remission or \<5% bone marrow blasts), confirmed relapse or death.