Myelodysplastic Syndromes Clinical Trial
Official title:
Phase II Trial of Gleevec and Low-Dose Ara-C for Elderly Patients With C-Kit Positive Acute Myeloid Leukemia and High-Risk Myelodysplastic Syndromes
The goal of this clinical research study is to learn if the combination of Gleevec (imatinib mesylate) and low doses of Cytarabine (ara-C) may help to control leukemia while causing fewer side effects than standard high dose chemotherapy.
Imatinib mesylate is a drug that blocks a certain protein. This protein is thought to be
important in the growth of leukemia cells. Ara-C is a chemotherapy drug that has been used
for many years to treat AML and MDS.
Imatinib mesylate (Gleevec) is a protein-tyrosine kinase inhibitor that inhibits the Bcr-Abl
tyrosine kinase, as well as the receptor tyrosine kinases for platelet- derived growth
factor (PDGF) and stem cell factor (SCF), c-Kit, and inhibits PDGF- and SCF-mediated
cellular events. c-Kit is expressed in over 90% of patients with AML.
The treatment of AML for patients age 65 or older with AML or high-risk MDS (age ³ 60 if
high-risk cytogenetics) have a poor prognosis with induction chemotherapy. Response rate is
no more than 45% with an induction mortality of at least 25%, and 1-year survival no better
than 20%. Indeed, most patients in these age groups are not even offered therapy and are
managed with supportive care only. Thus, new therapies that are better tolerated are needed.
Imatinib alone can induce response in nearly 20% of patients, and there is synergy with low
concentrations of ara-C. In this study we plan to investigate the combination of imatinib
and low-dose ara-C.
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Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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