Actively Recruiting
Ivosidenib and Venetoclax With or Without Azacitidine in Treating Patients With IDH1 Mutated Hematologic Malignancies
Led by M.D. Anderson Cancer Center · Updated on 2026-03-11
96
Participants Needed
4
Research Sites
497 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This phase Ib/II trial studies the side effects and best dose of venetoclax and how well it works when given together with ivosidenib with or without azacitidine, in treating patients with IDH1-mutated hematologic malignancies. Venetoclax and ivosidenib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as azacitidine, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving ivosidenib and venetoclax with azacitidine may work better in treating patients with hematologic malignancies compared to ivosidenib and venetoclax alone.
CONDITIONS
Official Title
Ivosidenib and Venetoclax With or Without Azacitidine in Treating Patients With IDH1 Mutated Hematologic Malignancies
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age greater than 18 years
- ECOG performance status less than 2
- IDH1-R132 mutated disease confirmed by local lab
- Relapsed or refractory acute myeloid leukemia, or newly diagnosed AML patients not eligible for standard chemotherapy
- Patients with high-risk myelodysplastic syndrome or myeloproliferative neoplasm who failed standard therapy may be eligible
- Adequate liver function (direct bilirubin less than 2 times upper limit, ALT and/or AST less than 3 times upper limit) unless due to leukemia
- Adequate kidney function with creatinine clearance greater than 30 ml/min
- Able and willing to provide informed consent
- At least 7 days since prior cytotoxic or immunotherapy treatment if disease is not rapidly progressing
- Male participants agree to use contraception and avoid sperm donation until 90 days after last dose
You will not qualify if you...
- Known allergy or hypersensitivity to ivosidenib or venetoclax
- Previous treatment with ivosidenib or venetoclax
- Uncontrolled significant medical conditions including infections or psychiatric illness
- Use of other chemotherapy or anti-leukemic agents during study except specific allowed cases
- Use of strong CYP3A inducers within 3 days before starting study drugs
- Active graft-versus-host disease after stem cell transplant unless controlled
- Severe gastrointestinal or metabolic conditions affecting oral drug absorption
- Concurrent active cancer under treatment
- QTc interval over 450 msec unless approved by investigator
- Active hepatitis B, hepatitis C, or HIV infection
- White blood cell count greater than 25 x 10^9/L (hydroxyurea allowed)
- Nursing women, pregnant women, or women of childbearing potential not using effective contraception
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 4 locations
1
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02215
Actively Recruiting
2
Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center
Cleveland, Ohio, United States, 44195
Actively Recruiting
3
Oregon Health and Science University
Portland, Oregon, United States, 97239
Actively Recruiting
4
M D Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
Research Team
C
Courtney DiNardo, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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