Actively Recruiting
Venetoclax With Combination Chemotherapy in Treating Patients With Newly Diagnosed or Relapsed or Refractory Acute Myeloid Leukemia
Led by M.D. Anderson Cancer Center · Updated on 2026-03-05
116
Participants Needed
1
Research Sites
522 weeks
Total Duration
On this page
Sponsors
M
M.D. Anderson Cancer Center
Lead Sponsor
N
National Cancer Institute (NCI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
This phase Ib/II trial studies the best dose and side effects of venetoclax and how well it works when given with combination chemotherapy in treating patients with newly diagnosed acute myeloid leukemia or acute myeloid leukemia that has come back or does not respond to treatment. Venetoclax may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as fludarabine, cytarabine, filgrastim and idarubicin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving venetoclax together with combination chemotherapy may work better in treating patients with acute myeloid leukemia.
CONDITIONS
Official Title
Venetoclax With Combination Chemotherapy in Treating Patients With Newly Diagnosed or Relapsed or Refractory Acute Myeloid Leukemia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosed with acute myeloid leukemia (AML) by WHO criteria or high-risk myelodysplastic syndrome with \u2265 10% blasts
- Patients older than 65 judged fit for intensive chemotherapy by the treating physician
- Eastern Cooperative Oncology Group (ECOG) performance status \u2264 2
- Creatinine clearance \u2265 30 mL/min by Cockcroft-Gault equation
- Total bilirubin less than 1.5 times the upper limit of normal unless due to Gilbert's disease or leukemia
- AST and/or ALT less than 3 times the upper limit of normal unless due to leukemia
- Ability to understand and provide signed informed consent
- Male patients must agree to avoid unprotected sex and sperm donation from first dose until 90 days after last dose
- For Part 1, patients must be relapsed, refractory, or intolerant of standard AML therapy with at least 1 prior AML-directed treatment
You will not qualify if you...
- Presence of t(15;17) chromosome abnormality or diagnosis of acute promyelocytic leukemia (FAB class M3-AML)
- Prior treatment with any BCL2 inhibitor
- Known active central nervous system involvement with AML
- New York Heart Association (NYHA) class III or IV heart failure or left ventricular ejection fraction below 40%
- History of myocardial infarction within 6 months, unstable angina, or severe/uncontrolled ventricular arrhythmias
- Known infection with HIV or active hepatitis B or C
- Conditions affecting oral drug absorption such as dysphagia or short-gut syndrome
- Other significant medical or psychiatric conditions that may affect study participation
- White blood cell count above 25 x 10^9/L (hydroxyurea allowed to meet this criterion)
- Nursing women, women of childbearing potential with positive pregnancy test, or women unwilling to use adequate contraception
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
M D Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
Research Team
D
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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