Idarubicin, Cytarabine, and Gemtuzumab Ozogamicin in Treating Patients With Previously Untreated High-Risk Myelodysplastic Syndrome or Acute Myeloid Leukemia Secondary to Myelodysplastic Syndrome
Leukemia, Myelodysplastic Syndromes
About this trial
This is an interventional treatment trial for Leukemia focused on measuring untreated adult acute myeloid leukemia, refractory anemia with excess blasts, refractory anemia with excess blasts in transformation, chronic myelomonocytic leukemia, de novo myelodysplastic syndromes, secondary myelodysplastic syndromes, adult acute myeloid leukemia with t(8;21)(q22;q22), adult acute myeloid leukemia with t(16;16)(p13;q22), adult acute myeloid leukemia with inv(16)(p13;q22), adult acute myeloid leukemia with 11q23 (MLL) abnormalities, adult acute myeloid leukemia with t(15;17)(q22;q12), childhood myelodysplastic syndromes
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically confirmed diagnosis of 1 of the following: High-risk myelodysplastic syndromes (MDS), including any of the following: Refractory anemia with excess blasts (RAEB) with > 10% blast cells in the bone marrow RAEB in transformation Other forms of MDS with multiple (3 or more) chromosomal abnormalities or chromosome 7 abnormalities AND/OR profound cytopenias, defined as neutrophil count < 500/mm^3 and/or platelet count < 20,000/mm^3 Chronic myelomonocytic leukemia with > 5% blast cells in the bone marrow Chronic myelomonocytic leukemia with neutrophil count > 16,000/mm^3 OR monocyte count > 2,600/mm^3 Secondary acute myeloid leukemia supervening after overt MDS of more than 6 months in duration Patients with or without an HLA-identical sibling No active CNS leukemia PATIENT CHARACTERISTICS: Age 16 to 70 Performance status WHO 0-2 Life expectancy Not specified Hematopoietic See Disease Characteristics Hepatic Bilirubin ≤ 1.5 times upper limit of normal (ULN) Renal Creatinine ≤ 1.5 times ULN Cardiovascular No severe cardiovascular disease No arrhythmias requiring chronic treatment No congestive heart failure No symptomatic ischemic heart disease Pulmonary No severe lung disease Other Not pregnant or nursing Fertile patients must use effective contraception No HIV positivity No other concurrent malignant disease No active uncontrolled infection No history of alcohol abuse (i.e., averaged less than 5 alcoholic consumptions daily for the past year) No concurrent severe neurological or psychiatric disease No other psychological, familial, sociological, or geographical condition that would preclude study compliance PRIOR CONCURRENT THERAPY: Biologic therapy More than 6 weeks since prior growth factors Chemotherapy No prior intensive chemotherapy More than 6 weeks since prior low-dose chemotherapy or hydroxyurea Endocrine therapy Not specified Radiotherapy Not specified Surgery Not specified Other More than 6 weeks since prior immunosuppressants No prior participation in this clinical study
Sites / Locations
- AZ Sint-Jan
- Institut Jules Bordet
- Cliniques Universitaires Saint-Luc
- H. Hartziekenhuis - Roeselaere.
- Ruprecht - Karls - Universitaet Heidelberg
- Onze Lieve Vrouwe Gasthuis
- Leiden University Medical Center
- Universitair Medisch Centrum St. Radboud - Nijmegen
- Universitaetsspital-Basel