Imatinib Mesylate Plus Cytarabine in Treating Patients With Chronic Myelogenous Leukemia

Phase 2TerminatedNCT00022490

OHSU Knight Cancer Institute24 enrolled

Overview

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Imatinib mesylate may stop the growth of cancer cells by blocking the enzymes necessary for cancer cell growth. PURPOSE: This phase II trial is studying giving imatinib mesylate together with cytarabine to see how well it works in treating patients with chronic phase chronic myelogenous leukemia.

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Leukemia

Interventions

cytarabineDRUG

Once daily subcutaneous injection of Ara-C (Cytarabine) at a dose of 20 mg (10 mg or 5 mg if they have been dose reduced) per square meter of calculated body surface area, on days 15-28 of each sequential 28 day cycle

imatinib mesylateDRUG

Once daily oral administration of STI571 (Imatinib Mesylate) at a dose of 400 mg for 12 months.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 120 Years

Medical Language ↔ Plain English

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

Locations (2)

Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute

Boston, Massachusetts, United States

OHSU Knight Cancer Institute

Portland, Oregon, United States

Outcomes

Primary Outcomes

The Rate of Major Cytogenetic Response at 6 Months

Cytogenetic response is defined in terms of the percentage of Philadelphia (Ph) chromosome. Major cytogenetic response is defined as 0-34% Ph-positive cells.

Time frame: 6 months

Secondary Outcomes

The Rate of Complete Cytogenetic Response at 6 Months

Time frame: 6 months

The Rate of Complete and Major Cytogenetic Responses at 12 Months

Time frame: 12 months

The Rate of Minor Cytogenetic Responses at 6 and 12 Months

Time frame: 6 and 12 months

The Rate of Complete Hematologic Responses at 6 and 12 Months

Time frame: 6 and 12 months

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.