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
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
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.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Efficacy of a combination of imatinib and low dose ara-C in elderly or high-risk patients with AML and MDS, as measured by the rate of early mortality or progression.
Jorge E Cortes, MD
The University of M.D. Anderson Cancer Center
United States: Institutional Review Board
|The University of Texas M.D. Anderson Cancer Center||Houston, Texas|