STI571 Compared With Interferon Alfa Plus Cytarabine in Treating Patients With Newly Diagnosed Ch… (NCT00006343) | Clinical Trial Compass
CompletedPhase 3
STI571 Compared With Interferon Alfa Plus Cytarabine in Treating Patients With Newly Diagnosed Chronic Myelogenous Leukemia
United StatesStarted 2000-06
Plain-language summary
RATIONALE: Biological therapies such as interferon-alfa and STI571 may interfere with the growth of cancer cells. It is not yet known if STI571 is more effective than interferon alfa plus cytarabine for chronic myelogenous leukemia.
PURPOSE: Randomized phase III trial to compare the effectiveness of STI571 with that of interferon alfa plus cytarabine in treating patients who have newly diagnosed chronic myelogenous leukemia.
Who can participate
Age range18 Years – 70 Years
SexALL
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DISEASE CHARACTERISTICS: Cytogenetically proven Philadelphia chromosome positive chronic phase chronic myelogenous leukemia (CML) Initial diagnosis within the past 6 months No prior chemotherapy, including regimens used in peripheral blood progenitor cell (PBPC) mobilization for PBPC transplantation, for CML except hydroxyurea Must meet the following criteria: Blasts in peripheral blood and bone marrow less than 15% Blasts plus promyelocytes in peripheral blood and bone marrow less than 30% Basophils in peripheral blood less than 20% Platelet count at least 100,000/mm3 No extramedullary leukemic involvement except spleen or liver No patient for which a sibling bone marrow donor is available and allogeneic bone marrow transplantation is elected as first line therapy
PATIENT CHARACTERISTICS: Age: 18 to 70 Performance status: ECOG 0-2 Life expectancy: Not specified Hematopoietic: See Disease Characteristics Hepatic: Bilirubin no greater than 1.5 times upper limit of normal (ULN) SGOT and SGPT no greater than 1.5 times (ULN) INR and PTT no greater than 1.5 times ULN Renal: Creatinine no greater than 1.5 times ULN Cardiovascular: No angina No New York Heart Association class III or IV heart disease Other: No uncontrolled medical disease, such as diabetes mellitus, thyroid dysfunction, neuropsychiatric disorders, or infection HIV negative Not pregnant or nursing Negative pregnancy test Fertile patients must use effective barrier contraception No other malignancy within the past 5 …