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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

Phase 2
60 Years
Not Enrolling
Leukemia, Myeloid, Myelodysplastic Syndromes

Thank you

Trial Information

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

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

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.

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

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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.

Outcome Time Frame:

April 2007

Safety Issue:


Principal Investigator

Jorge E Cortes, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

The University of M.D. Anderson Cancer Center


United States: Institutional Review Board

Study ID:




Start Date:

March 2004

Completion Date:

April 2007

Related Keywords:

  • Leukemia, Myeloid
  • Myelodysplastic Syndromes
  • AML
  • MDS
  • Gleevec
  • Ara-C
  • C-Kit Positive Acute Myeloid Leukemia
  • High-Risk Myelodysplastic Syndromes
  • Leukemia
  • Leukemia, Myeloid, Acute
  • Leukemia, Myeloid
  • Myelodysplastic Syndromes
  • Preleukemia



The University of Texas M.D. Anderson Cancer Center Houston, Texas