Combination Chemotherapy in Treating Patients With Relapsed Acute Myelogenous Leukemia (NCT00003758) | Clinical Trial Compass
UnknownPhase 2
Combination Chemotherapy in Treating Patients With Relapsed Acute Myelogenous Leukemia
Belgium, Croatia60 participantsStarted 1998-12
Plain-language summary
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining more than one drug may kill more cancer cells.
PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy consisting of cytarabine plus idarubicin in treating patients who have relapsed acute myelogenous leukemia.
Who can participate
Age range15 Years – 60 Years
SexALL
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DISEASE CHARACTERISTICS: First bone marrow relapse of primary acute myelogenous leukemia (AML), all subtypes except M3 OR First bone marrow relapse of secondary AML that occurred after other malignancies, but cured, or after alkylating agents and/or radiotherapy, or after myelodysplastic syndrome No previously untreated AML or second or subsequent relapse of AML No isolated extramedullar localization of AML Must have achieved a first complete remission No leukemias after other myeloproliferative diseases
PATIENT CHARACTERISTICS: Age: 15 to 60 Performance status: WHO 0-2 Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Bilirubin no greater than 1.5 times upper limit of normal (ULN) Alkaline phosphatase no greater than 1.5 times ULN AST no greater than 1.5 times ULN Renal: Creatinine no greater than 1.5 times ULN Cardiovascular: No cardiac contraindications to anthracycline chemotherapy Ventricular ejection fraction at least 45% Other: No uncontrolled infection No concurrent severe neurological or psychiatric disease No other progressive malignant nonhematological disease
PRIOR CONCURRENT THERAPY: Biologic therapy: No prior allogeneic or autologous bone marrow or peripheral stem cell transplant Chemotherapy: See Disease Characteristics Endocrine therapy: Not specified Radiotherapy: See Disease Characteristics Surgery: Not specified
Trial details
NCT IDNCT00003758
SponsorEuropean Organisation for Research and Treatment of Cancer - EORTC