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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


Phase 2
18 Years
N/A
Not Enrolling
Both
Leukemia

Thank you

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 InstituteBoston, Massachusetts  02115
OHSU Knight Cancer InstitutePortland, Oregon  97239