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I-DATA Study: Comparing Treatment Order for Newly Diagnosed IDH-Mutated AML

This study is for people with newly diagnosed acute myeloid leukemia (AML) who have specific genetic changes called IDH1 or IDH2 mutations and cannot receive intensive chemotherapy. It compares two different orders of treatment using several medications: ivosidenib, enasidenib, azacitidine, and venetoclax. Ivosidenib and enasidenib work by slowing cancer cell growth. Venetoclax also stops cancer cell growth, and azacitidine is another type of medication used in cancer treatment. The study wants to see which order of these treatments is better at preventing overall treatment failure after 12 months. About 125 people are expected to join this study.

Study design
This is a phase II interventional study comparing two different sequences of drug treatments. It plans to enroll 125 participants.
What's involved
You would undergo a bone marrow biopsy and receive medications either intravenously (IV), subcutaneously (SC), or by mouth (PO).
Compensation
Not stated in the trial record.
Follow-up
The primary outcome measures overall treatment failure at 12 months from the date you are randomly assigned to a treatment group.

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

NCT05401097

IDH Targeted/Non- Targeted vs Non-targeted/IDH-targeted Approaches in the Treatment of Newly Diagnosed IDH Mutated AML Patients Not Candidates for Intensive Induction Therapy (I- DATA Study)

Recruiting
PHASE2Ages 18+InterventionalTreatment
Alice Mims
~125 participants
Updated 2026-06-23 on ClinicalTrials.gov
What's tested:AzacitidineBiopsyEnasidenibIvosidenibVenetoclax

At a glance

Recruiting sites
4 of 4 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Overall treatment failure
Measured over At 12 months from date of randomization

Conditions

Acute Myeloid Leukemia

Explore related trials

Acute Myeloid LeukemiaIDH1 GeneIDH2 Gene

Where it's being run

4 sites across 4 states
Colorado1
North Carolina1
Ohio1
Texas1

Study leadership

  • Alice S Mims, MD · PRINCIPAL_INVESTIGATOR · Ohio State University Comprehensive Cancer Center

Who to contact

The Ohio State University Comprehensive Cancer Center
[email protected]
800-293-5066
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Patients with newly diagnosed IDH1 or IDH2 mutated AML
Not a candidate for or refuses intensive induction therapy
Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
Creatinine clearance \> 40 ml/min
Aspartate aminotransferase (AST)/ alanine aminotransferase (ALT) \< 5 x upper limit of normal
Total bilirubin \< 1.5 x upper limit of normal (except for patients with Gilbert's disease)
At the time of Venetoclax initiation, white blood cells (WBC) needs to be \< 25 × 103 microliter: Hydroxyurea can be used to achieve that level.
For female patients of childbearing potential, willingness to abstain from heterosexual intercourse or use a protocol-recommended method of contraception from the screening visit throughout the study treatment period and for 6 months following the last dose of either study drug. A serum pregnancy test will be done at screening. A serum or urine pregnancy test will be done on Day 1 of each cycle for women of childbearing potential. If the urine pregnancy test is positive, a serum pregnancy test must be performed per institutional standards.
Highly Effective Contraception Methods that can achieve a failure rate of less than 1% per year when used consistently and correctly are considered as highly effective birth control methods (Clinical Trials Facilitation Group 2014):
Combined (estrogen and progestin containing) hormonal contraception associated with inhibition of ovulation (oral, intravaginal, transdermal).
Progestin-only hormonal contraception associated with inhibition of ovulation (oral, injectable, implantable).
Intrauterine device.
Intrauterine hormone-releasing system.
Bilateral tubal occlusion.
Vasectomized partner, provided that partner is the sole sexual partner of the female study participant and that the vasectomized partner has received medical assessment of the surgical success.
Sexual abstinence- only if defined as refraining from heterosexual intercourse during the entire period of risk associated with the study treatments. The reliability of sexual abstinence needs to be evaluated in relation to the duration of the clinical study and the preferred and usual lifestyle of the patient.
Acceptable Birth Control Methods that are not Highly Effective Contraception Acceptable birth control methods that result in a failure rate of more than 1% per year:
Progestin-only oral hormonal contraception, where inhibition of ovulation is not the primary mode of action.
Male or female condom with or without spermicide.
Cap, diaphragm, or sponge with spermicide. A combination of male condom with either cap, diaphragm, or sponge with spermicide (double barrier methods) are also acceptable, but not highly effective, birth control methods.
The following methods are NOT acceptable methods of contraception for the purpose of this study:
Periodic abstinence (calendar, symptothermal, postovulation methods).
Withdrawal (coitus interruptus).
Spermicides only.
Lactational amenorrhea method.
Combination of male and female condom
For male patients of childbearing potential having intercourse with females of childbearing potential, the willingness to abstain from heterosexual intercourse or use a protocol recommended method of contraception from the screening visit throughout the study treatment period and for 3 months following the last dose of either study drug. Males must also refrain from sperm donation from the screening visit throughout the study treatment period and for 3 months following the last dose of either dose of study drug
Willingness to comply with scheduled visits, drug administration plan, imaging studies, laboratory tests, other study procedures and study restrictions

Exclusion

Patients with acute promyelocytic leukemia
Known active central nervous system involvement of leukemia
Any active malignancy requiring therapy, that would interfere with the interpretation of study endpoints.
Evidence of ongoing uncontrolled systemic bacterial, fungal or viral infection at the time of start of study treatment
Uncontrolled infection with hepatitis C, hepatitis B, or human immunodeficiency virus (HIV)
Pregnancy or breast feeding
Concurrent participation in an investigational drug trial with therapeutic intent defined as prior study therapy within 14 days prior to study treatment
Inability to tolerate oral medications including symptomatic disease significantly affecting gastrointestinal function such as inflammatory bowel disease or resection of stomach or small bowel

What this trial measures

  • Overall treatment failureAt 12 months from date of randomization

    Defined as: 1) second occurrence of any of disease progression, relapse, failure to achieve complete remission (CR)/complete remission with hematologic improvement (CRh)/complete remission with incomplete blood count recovery (CRi), or 2) death from any cause. Within each treatment sequence, overall treatment failure rate will be defined as the number of patients with events divided by the number of eligible patients randomized. Patients who go to transplant will be considered a treatment success for a particular treatment sequence. All randomized patients meeting the eligibility criteria will be evaluable for treatment failure status by intention to treat. Will be analyzed using a Cochran-Mantel-Haenszel test, testing for a difference in proportions and stratifying on isocitrate dehydrogenase (IDH) mutation status.