Gleevec/Low-Dose Ara-C Study for Elderly Patients With AML and 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.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|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|
- 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. [ Time Frame: April 2007 ] [ Designated as safety issue: Yes ]
- Rate of overall response, including CRp and PR. [ Time Frame: April 2007 ] [ Designated as safety issue: No ]
- To determine the safety profile of this combination. [ Time Frame: April 2007 ] [ Designated as safety issue: Yes ]
- To determine the impact on long-term survival of this therapy. [ Time Frame: April 2007 ] [ Designated as safety issue: No ]
- To determine the duration of responses obtained with this therapy. [ Time Frame: April 2007 ] [ Designated as safety issue: No ]
- To determine the impact of this therapy in cognitive function. [ Time Frame: April 2007 ] [ Designated as safety issue: No ]
- To determine the effect of this approach in quality of life of this patient population. [ Time Frame: April 2007 ] [ Designated as safety issue: No ]
- To determine the overall costs (health economic analysis) associated with this combination therapy. [ Time Frame: April 2007 ] [ Designated as safety issue: No ]
|Study Start Date:||March 2004|
|Study Completion Date:||April 2007|
|Primary Completion Date:||August 2005 (Final data collection date for primary outcome measure)|
|Experimental: Gleevec + Low-Dose Ara-C||
600 mg (capsules) by mouth once daily
Other Names:Drug: Ara-C
10 mg as an injection under the skin daily for 21 days of every 28 day cycle
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.
|United States, Texas|
|The University of Texas M.D. Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Jorge E Cortes, MD||The University of M.D. Anderson Cancer Center|