Actively Recruiting
Cladribine Plus Low Dose Cytarabine (LDAC) Alternating With Decitabine in Patients With Acute Myeloid Leukemia (AML) or High-Risk Myelodysplastic Syndrome (MDS)
Led by M.D. Anderson Cancer Center · Updated on 2026-02-06
160
Participants Needed
1
Research Sites
834 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The goal of this clinical research study is to learn if cladribine given in combination with low-dose cytarabine (LDAC) and decitabine can help control the disease in patients with AML or MDS. The safety of this drug combination will also be studied. Cladribine is designed to interfere with the cell's ability to process DNA (the genetic material of cells). It can also insert itself into the DNA of cancer cells to stop them from growing and repairing themselves. Cytarabine is designed to insert itself into DNA of cancer cells to stop them from growing and repairing themselves. Decitabine is designed to damage the DNA of cells, which may cause cancer cells to die. This is an investigational study. Cladribine is FDA approved and commercially available for use in patients with hairy cell leukemia. Its use in patients with AML is investigational. Cytarabine is FDA approved and commercially available for use in patients with AML. Decitabine is FDA approved and commercially available for use in patients with MDS. Its use for patients with AML is investigational. Up to 160 patients will take part in this study. All will be enrolled at MD Anderson.
CONDITIONS
Official Title
Cladribine Plus Low Dose Cytarabine (LDAC) Alternating With Decitabine in Patients With Acute Myeloid Leukemia (AML) or High-Risk Myelodysplastic Syndrome (MDS)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with previously untreated AML or high-risk MDS with at least 10% blasts or intermediate-2 IPSS score
- Prior therapy with hydroxyurea, hematopoietic growth factors, azacytidine, ATRA, or low-dose cytarabine allowed
- Age 60 years or older; patients under 60 unsuitable for standard therapy may be eligible
- Adequate liver function (bilirubin less than 2 mg/dL, AST/ALT less than 3 times upper limit normal)
- Adequate kidney function (creatinine less than 1.5 times upper limit normal)
- ECOG performance status of 2 or less
- Negative urine pregnancy test within 1 week before enrollment for women of childbearing potential
- Ability to understand study requirements and provide signed informed consent
- Prior decitabine therapy allowed unless progression to AML occurred during that treatment
- Patients with previously untreated AML not eligible for other frontline trials may be included
- Patients with relapsed or refractory AML with prior therapy allowed
- Prior venetoclax therapy allowed for relapsed/refractory patients
You will not qualify if you...
- Pregnant or breastfeeding women
- Uncontrolled illness including active infection, symptomatic heart failure, unstable angina, cardiac arrhythmia, or psychiatric illness that limits compliance
- Known allergy to any chemotherapy components
- Men and women of childbearing potential not practicing contraception
- Illnesses unrelated to leukemia that limit participation unless judged related to leukemia
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
Research Team
T
Tapan Kadia, 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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