Actively Recruiting
Venetoclax, Cladribine, Low Dose Cytarabine, and Azacitidine in Treating Patients With Previously Untreated Acute Myeloid Leukemia
Led by M.D. Anderson Cancer Center · Updated on 2026-04-17
145
Participants Needed
1
Research Sites
444 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This phase II trial studies how well venetoclax, cladribine, low dose cytarabine, and azacitidine work in treating patients with acute myeloid leukemia that has previously not been treated. Drugs used in chemotherapy, such as venetoclax, cladribine, and low dose cytarabine, 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. Azacitidine may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving venetoclax, cladribine, low dose cytarabine induction followed by cladribine, low dose cytarabine, and azacitidine consolidation may work better in treating patients with acute myeloid leukemia.
CONDITIONS
Official Title
Venetoclax, Cladribine, Low Dose Cytarabine, and Azacitidine in Treating Patients With Previously Untreated Acute Myeloid Leukemia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Previously untreated acute myeloid leukemia (AML) patients; prior limited therapy such as hydroxyurea or low-dose cytarabine allowed for stabilization
- Age 50 years or older (patients under 50 may be eligible if unsuitable for standard therapy after discussion with investigator)
- Adequate liver function (bilirubin below 2mg/dL, AST/ALT less than 3 times upper limit of normal unless due to leukemia)
- Adequate kidney function (creatinine less than 1.5 times upper limit of normal)
- ECOG performance status 2 or less
- Negative pregnancy test within one week before enrollment for women of childbearing potential
- Ability to understand and sign informed consent
You will not qualify if you...
- Pregnancy or breastfeeding
- Uncontrolled illnesses such as active infection, symptomatic heart failure, unstable angina, arrhythmia, or psychiatric/social issues limiting compliance
- Known allergy to any chemotherapy drugs used in the study
- Men and women of childbearing potential who do not use contraception during and after the study
- Prior treatment with venetoclax
- Diagnosis of acute promyelocytic leukemia (AML-M3)
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
M D Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
Research Team
T
Tapan Kadia
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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