A Phase II Study To Determine The Anti-Leukemic Effects Of STI571 In Combination With Ara-C In Patients With Chronic Myelogenous Leukemia In Chronic Phase
18 Years
N/A
Both
Leukemia
Trial Information
A Phase II Study To Determine The Anti-Leukemic Effects Of STI571 In Combination With Ara-C In Patients With Chronic Myelogenous Leukemia In Chronic Phase
OBJECTIVES:
- Determine the rate and duration of complete or major and minor cytogenetic responses
after 6 and 12 months of treatment in patients with chronic phase chronic myelogenous
leukemia treated with imatinib mesylate and cytarabine.
- Determine the rate and duration of complete hematologic responses after 6 and 12 months
of treatment in patients treated with this regimen.
- Determine the rate of molecular response in patients with a complete cytogenetic
response after 6 and 12 months of treatment with this regimen.
- Determine the pharmacokinetics of this regimen in these patients.
- Determine the safety of this regimen in these patients.
OUTLINE: This is a nonrandomized, open-label, multicenter study.
Patients receive oral imatinib mesylate on days 1-28 and cytarabine subcutaneously on days
15-28. Courses repeat every 28 days for 12 months in the absence of disease progression or
unacceptable toxicity.
Patients are followed for 30-60 days.
PROJECTED ACCRUAL: A total of 15 patients will be accrued for this study.
Inclusion Criteria
DISEASE CHARACTERISTICS:
- Cytogenetically confirmed chronic phase chronic myelogenous leukemia (CML)
- Less than 15% blasts in peripheral blood or bone marrow
- Less than 30% blasts and promyelocytes in peripheral blood or bone marrow
- Less than 20% basophils in blood or bone marrow
- Platelet count at least 100,000/mm^3
- Philadelphia chromosome positive
- No more than 6 months since initial diagnosis
- No presence of leukemia beyond the bone marrow, blood, liver, or spleen (i.e.,
chloroma)
- Refused allogeneic stem cell transplantation as first-line therapy
PATIENT CHARACTERISTICS:
Age:
- 18 and over
Performance status:
- Eastern Cooperative Oncology Group (ECOG) 0-2
Life expectancy:
- Not specified
Hematopoietic:
- See Disease Characteristics
Hepatic:
- Bilirubin no greater than 1.5 times upper limit of normal (ULN)
- AST or ALT no greater than 2 times ULN
Renal:
- Creatinine no greater than 1.5 times ULN
Cardiovascular:
- No New York Heart Association class III or IV heart disease
Other:
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective barrier contraception during and for at least 3
months after study participation
- No other serious uncontrolled medical condition
- No history of noncompliance to medical regimens or potential unreliability
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- See Disease Characteristics
- No prior biologic therapy for CML
Chemotherapy:
- No prior chemotherapy for CML except hydroxyurea
- Concurrent hydroxyurea to control blood counts during first 3 months of treatment
allowed
- No other concurrent chemotherapy
Endocrine therapy:
- No prior endocrine therapy for CML
Radiotherapy:
- No prior radiotherapy for CML
Surgery:
- Not specified
Other:
- More than 28 days since prior investigational anticancer agents
- Prior anagrelide hydrochloride for CML allowed
- Concurrent anagrelide hydrochloride to control blood counts during first 3 months of
treatment allowed
- No concurrent grapefruit juice or grapefruit
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
The Rate of Major Cytogenetic Response at 6 Months
Outcome Description:
Cytogenetic response is defined in terms of the percentage of Philadelphia (Ph) chromosome. Major cytogenetic response is defined as 0-34% Ph-positive cells.
Outcome Time Frame:
6 months
Safety Issue:
No
Principal Investigator
Brian J. Druker, MD
Investigator Role:
Study Chair
Investigator Affiliation:
OHSU Knight Cancer Institute
Authority:
United States: Federal Government
Study ID:
CDR0000068822
NCT ID:
NCT00022490
Start Date:
June 2001
Completion Date:
July 2011
Related Keywords:
- Leukemia
- chronic phase chronic myelogenous leukemia
- Philadelphia chromosome positive chronic myelogenous leukemia
- Leukemia
- Leukemia, Myeloid
- Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Name | Location |
|---|---|
| Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute | Boston, Massachusetts 02115 |
| OHSU Knight Cancer Institute | Portland, Oregon 97239 |
