Gleevec/Low-Dose Ara-C Study for Elderly Patients With AML and Myelodysplastic Syndromes
Completed · Phase 2
Conditions studied: Leukemia, Myeloid, Myelodysplastic Syndromes
In brief
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.
Key facts
- Study ID
- NCT00451997
- Run by
- M.D. Anderson Cancer Center
- People needed
- 10
- Starts
- 2004-03-01
- Expected to finish
- 2007-04-01
- Last updated by the study team
- 2012-08-01
Who can join
Age: 60 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- Patients with uncontrolled active infection
- Patients with NYHA class III or IV
- Women who are pregnant
- Women who are breast feeding
Where it is running
- The University of Texas M.D. Anderson Cancer Center — Houston, Texas, United States
Full record on ClinicalTrials.gov
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