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)

The film gives the main points. The full list below is copied from the registry; the study team makes the final decision.

• Age18 Years to no maximum
• SexAll
• Healthy volunteersNo

You may be able to join if

• 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.
• The following methods are acceptable methods of contraception for the purpose of this study:
• 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

You cannot join if

• 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

This is how the treatment is meant to work. Whether it helps, and how safe it is, is what this trial is testing.

Treatments listed in the registry

• Azacitidine (Drug): Given IV or SC
• Biopsy (Procedure): Undergo biopsy of the bone marrow
• Enasidenib (Drug): Given PO
• Ivosidenib (Drug): Given PO
• Venetoclax (Drug): Given PO

Randomized · Sequential · masking: None

As the registry describes them. Requirements to join, such as a tissue sample, are in the eligibility list above even when on-study procedures are optional. Ask the study team which steps apply to you.

• biopsy: Part of the study plan

Main goals

• Overall treatment failure (At 12 months from date of randomization)

Other goals

• Difference in treatment failure rates between the two arms
• Overall survival (OS)
• Duration of response

Planned enrollment: 125 (estimated).

• University of Colorado, Aurora, Colorado
• UNC Hospitals, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina
• Ohio State University Comprehensive Cancer Center, Columbus, Ohio
• UT Southwestern Medical Center at Dallas, Dallas, Texas

Site status as of Oct 30, 2026. Check the live record before contacting a site.

• ClinicalTrials.gov NCT05401097

Registry record reviewed as fetched Oct 30, 2026, last updated by the sponsor Jun 22, 2026. Public record; not medical advice.