Imatinib Mesylate and Cytarabine in Treating Patients With Newly Diagnosed Chronic Myeloid Leukemia

Commissie Voor Klinisch Toegepast Onderzoek60 enrolled

Overview

RATIONALE: Imatinib mesylate may stop the growth of cancer cells by blocking the enzymes necessary for cancer cell growth. Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining imatinib mesylate and chemotherapy may kill more cancer cells. PURPOSE: Phase I/II trial to study the effectiveness of imatinib mesylate plus cytarabine in treating patients who have newly diagnosed chronic myeloid leukemia.

OBJECTIVES: * Determine the maximum tolerated dose of imatinib mesylate and cytarabine in patients with newly diagnosed chronic phase chronic myeloid leukemia. * Determine the feasibility of this regimen as defined by dose-limiting toxicity of this regimen and treatment-related mortality in no more than 5% of these patients. * Determine the rate and duration of molecular response, complete hematological response, and complete cytogenetic response in patients treated with this regimen. * Determine the time to treatment failure of patients treated with this regimen. * Determine the overall survival of patients treated with this regimen. OUTLINE: This is a multicenter, dose-escalation study of imatinib mesylate and cytarabine. Patients receive oral imatinib mesylate alone once daily on days 1-21. Patients then receive oral imatinib mesylate once daily and cytarabine IV over 1-3 hours on days 1-7. Combination therapy repeats every 28-42 days for 2 courses. Patients then receive maintenance oral imatinib mesylate once daily. Treatment continues in the absence of disease progression or unacceptable toxicity. Cohorts of 5-20 patients receive escalating doses of imatinib mesylate and cytarabine until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 5/5, 5/10, or 5/20 patients experience dose-limiting toxicity. Patients are followed every 6 months. PROJECTED ACCRUAL: A total of 30-60 patients will be accrued for this study within 2 years.

Study Type

INTERVENTIONAL

Purpose

TREATMENT

Enrollment

Conditions

Leukemia

Interventions

cytarabineDRUG

imatinib mesylateDRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

DISEASE CHARACTERISTICS: * Newly diagnosed chronic myeloid leukemia in first chronic phase (within the past 6 months) * Philadelphia-chromosome positive OR * bcr-abl rearrangement * No prior treatment within the past 6 months other than hydroxyurea PATIENT CHARACTERISTICS: Age: * 18 to 65 Performance status: * WHO 0-2 Life expectancy: * Not specified Hematopoietic: * Not specified Hepatic: * No hepatic dysfunction * Bilirubin less than 2 times normal * ALT less than 4 times normal Renal: * No renal dysfunction * Creatinine less than 2.3 mg/dL Cardiovascular: * No severe cardiac dysfunction * No New York Heart Association class II-IV heart disease Pulmonary: * No severe pulmonary disease Other: * HIV negative * No severe neurologic disease * No active uncontrolled infection * No other active malignancy within the past 5 years except basal cell skin cancer or stage 0 cervical cancer * Not pregnant or nursing PRIOR CONCURRENT THERAPY: Biologic therapy: * See Disease Characteristics * No concurrent allogeneic transplantation with an HLA-A, B, DR-matched sibling donor or matched-unrelated donor Chemotherapy: * See Disease Characteristics Endocrine therapy: * See Disease Characteristics Radiotherapy: * See Disease Characteristics Surgery: * See Disease Characteristics Other: * No concurrent grapefruit or grapefruit juice

Locations (16)

AZ Sint-Jan

Bruges, Belgium

Institut Jules Bordet

Brussels, Belgium

Cliniques Universitaires Saint-Luc

Outcomes

Primary Outcomes

Incidence of dose-limiting toxicity and treatment-related toxicity per dose level

Secondary Outcomes

Rate and duration of molecular response

Rate and duration of complete hematological response

Rate and duration of complete cytogenetic response

Time to treatment failure

Overall survival

Data from ClinicalTrials.gov

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