Actively Recruiting
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)
Led by Alice Mims · Updated on 2026-05-13
125
Participants Needed
2
Research Sites
354 weeks
Total Duration
On this page
Sponsors
A
Alice Mims
Lead Sponsor
N
National Cancer Institute (NCI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
This phase II study compares the order of treatment with ivosidenib or enasidenib and azacitidine plus venetoclax in treating older patients with acute myeloid leukemia with genetic changes in the IDH1 or IDH2 genes (IDH mutated). Ivosidenib is in a class of medications called isocitrate dehydrogenase-1 (IDH1) inhibitors. It works by slowing or stopping the growth of cancer cells. Enasidenib is in a class of medications called an IDH2 inhibitor. It also works by slowing or stopping the growth of cancer cells. Venetoclax is in a class of medications called B-cell lymphoma-2 (BCL-2) inhibitors. It may stop the growth of cancer cells by blocking Bcl-2, a protein needed for cancer cell survival. Azacitidine is in a class of medications called demethylation agents. It works by helping the bone marrow to produce normal blood cells and by killing abnormal cells. This study may help researchers determine which treatment order is best for older patients with IDH mutated acute myeloid leukemia: 1) ivosidenib or enasidenib followed by azacitidine plus venetoclax; or 2) azacitidine plus venetoclax followed by ivosidenib or enasidenib.
CONDITIONS
Official Title
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)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with newly diagnosed IDH1 or IDH2 mutated acute myeloid leukemia
- Not a candidate for or refuses intensive induction chemotherapy
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
- Creatinine clearance greater than 40 ml/min
- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) less than five times the upper limit of normal
- Total bilirubin less than 1.5 times the upper limit of normal (except for patients with Gilbert's disease)
- White blood cell count less than 25 x 10^3 per microliter at the start of venetoclax treatment (hydroxyurea may be used to reduce levels)
- For females of childbearing potential, willingness to abstain from heterosexual intercourse or use study-approved contraception during treatment and for 30 days after last dose
- For males of childbearing potential, willingness to abstain from heterosexual intercourse or use study-approved contraception during treatment and for 90 days after last dose, and to refrain from sperm donation
- Willingness to follow study visits, medication plan, tests, and procedures
You will not qualify if you...
- Patients with acute promyelocytic leukemia
- Known active leukemia involvement in the central nervous system
- History of active non-myeloid cancer within 5 years except for certain treated skin, cervical, bladder, or prostate cancers
- Ongoing uncontrolled bacterial, fungal, or viral infections at the start of treatment
- Uncontrolled hepatitis B, hepatitis C, or HIV infection
- Pregnancy or breastfeeding
- Participation in another therapeutic investigational drug trial within 14 days prior to study treatment
- Inability to take oral medications due to significant gastrointestinal issues such as inflammatory bowel disease or surgery
AI-Screening
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Trial Site Locations
Total: 2 locations
1
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, United States, 43210
Actively Recruiting
2
UT Southwestern Medical Center at Dallas
Dallas, Texas, United States, 75235
Actively Recruiting
Research Team
T
The Ohio State University Comprehensive Cancer Center
CONTACT
M
Molly Brandenburg
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
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