Overview

Gleevec/Low-Dose Ara-C Study for Elderly Patients With AML and Myelodysplastic Syndromes

Status:
Completed
Trial end date:
2007-04-01
Target enrollment:
0
Participant gender:
All
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 than standard high dose chemotherapy.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
M.D. Anderson Cancer Center
Collaborator:
Novartis
Treatments:
Cytarabine
Imatinib Mesylate
Criteria
Inclusion Criteria:

- 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 bilirubin
- 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 uncontrolled active infection

- Patients with NYHA class III or IV

- Women who are pregnant

- Women who are breast feeding