Cladribine Plus Low Dose Cytarabine (LDAC) Alternating With Decitabine in Patients With Acute Myeloid Leukemia (AML) or High-Risk Myelodysplastic Syndrome (MDS)

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

Trial Details

NCT ID

NCT01515527

Phase

PHASE2

Sponsor

M.D. Anderson Cancer Center

Status

RECRUITING

Cancer Type

Leukemia

Interventions

Cladribine
Cytarabine
Decitabine

Locations (sample)

Houston, Texas, United States|29.76328,-95.36327

Key Eligibility Criteria

Patients with previously untreated AML or high risk MDS (\>/= 10 % blasts or IPSS \>/= intermediate-2). Prior therapy with hydroxyurea, hematopoiet…
Age \>/= 60 years. Patients aged \< 60 years who are unsuitable for standard induction therapy may be eligible after discussion with PI
Adequate organ function as defined below:
liver function (bilirubin \< 2mg/dL, AST and/or ALT \<3 x ULN)

For full eligibility, visit ClinicalTrials.gov.

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