Gleevec/Low-Dose Ara-C Study for Elderly Patients With AML and Myelodysplastic Syndromes
NCT ID: NCT00451997
Last Updated: 2012-08-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
10 participants
INTERVENTIONAL
2004-03-31
2007-04-30
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Gleevec + Low-Dose Ara-C
Gleevec
600 mg (capsules) by mouth once daily
Ara-C
10 mg as an injection under the skin daily for 21 days of every 28 day cycle
Interventions
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Gleevec
600 mg (capsules) by mouth once daily
Ara-C
10 mg as an injection under the skin daily for 21 days of every 28 day cycle
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Patients with WHO performance status of 0 to 2
* Patients must have recovered from prior cytotoxic chemotherapy; treatment with hydrea is allowed up to 24 hours prior to day 1 of study drug administration
* Written informed consent obtained according to local guidelines
* Patients must have a serum creatinine of \</= 1.5 x ULN, SGPT \</= 3 x ULN and total bilirubin \</= 2.0 x ULN.
* Patients with \>/= 20% blasts positive for c-kit (CD117) (except for CMML)
* Postmenopausal women must be amenorrheic for at least 12 months to be considered of non-childbearing potential. Male and female patients of childbearing potential must agree to employ an effective method of birth control throughout the study and for up to 3 months following discontinuation of study drug.
Exclusion Criteria
* Patients with NYHA class III or IV
* Women who are pregnant
* Women who are breast feeding
60 Years
ALL
No
Sponsors
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Novartis
INDUSTRY
M.D. Anderson Cancer Center
OTHER
Responsible Party
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Principal Investigators
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Jorge E Cortes, MD
Role: PRINCIPAL_INVESTIGATOR
The University of M.D. Anderson Cancer Center
Locations
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The University of Texas M.D. Anderson Cancer Center
Houston, Texas, United States
Countries
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Related Links
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M.D. Anderson's website
Other Identifiers
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2003-0935
Identifier Type: -
Identifier Source: org_study_id