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

• Status: Unknown status
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Commissie Voor Klinisch Toegepast Onderzoek
• Treatments: Cytarabine; Imatinib Mesylate

Criteria

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