Status:
COMPLETED
Gleevec/Low-Dose Ara-C Study for Elderly Patients With AML and Myelodysplastic Syndromes
Lead Sponsor:
M.D. Anderson Cancer Center
Collaborating Sponsors:
Novartis
Conditions:
Leukemia, Myeloid
Myelodysplastic Syndromes
Eligibility:
All Genders
60+ years
Phase:
PHASE2
Brief Summary
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...
Detailed Description
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 tr...
Eligibility Criteria
Inclusion
- Patients who are not candidates for intensive chemotherapy with any of the following diagnosis: 1. AML or MDS (with \>/=5% blasts) age \>/= 65 years old (or age \>/= 60 if high-risk cytogenetics), or 2. AML or MDS (RAEB or RAEBT) of any cytogenetic group age 60 or older with minimally treated disease who have relapsed disease or are refractory to therapy and not likely to require cytoreductive therapy within one month, and, or 3. CMML.
- 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
- Patients with uncontrolled active infection
- Patients with NYHA class III or IV
- Women who are pregnant
- Women who are breast feeding
Key Trial Info
Start Date :
March 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2007
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT00451997
Start Date
March 1 2004
End Date
April 1 2007
Last Update
August 1 2012
Active Locations (1)
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1
The University of Texas M.D. Anderson Cancer Center
Houston, Texas, United States, 77030