Combination Chemotherapy With or Without Peripheral Stem Cell Transplantation in Treating Patients With Myelodysplastic Syndrome or Acute Myelogenous Leukemia
Leukemia, Myelodysplastic Syndromes
About this trial
This is an interventional treatment trial for Leukemia focused on measuring secondary acute myeloid leukemia, refractory anemia, refractory anemia with ringed sideroblasts, refractory anemia with excess blasts, refractory anemia with excess blasts in transformation, chronic myelomonocytic leukemia, de novo myelodysplastic syndromes, previously treated myelodysplastic syndromes, secondary myelodysplastic syndromes, refractory cytopenia with multilineage dysplasia, childhood myelodysplastic syndromes
Eligibility Criteria
DISEASE CHARACTERISTICS: Pathological confirmation of one of the following: Untreated refractory anemia with excess blasts (RAEB) in transformation RAEB with greater than 10% blasts cells in the bone marrow Other myelodysplastic syndromes Profound cytopenias Acute myelogenous leukemia (AML) supervening after overt myelodysplastic syndromes (MDS) of more than 6 months duration No blast crisis of chronic myeloid leukemia No leukemias supervening after other myeloproliferative disease No leukemias supervening after overt MDS of less than 6 months duration The following are allowed: Secondary acute leukemias following Hodgkin's disease or other malignancies Secondary leukemias following exposure to alkylating agents or radiation PATIENT CHARACTERISTICS: Age: 16-60 Performance status: WHO 0-2 Hematopoietic: If RAEB, blasts cells of greater than 10% in bone marrow Neutrophil count less than 5,000 or Platelet count less than 200,000 Chronic myelomonocytic leukemia (CMML) with greater than 5% blasts cells in bone marrow, or CMML with neutrophil count greater than 160,000 or monocyte count greater than 2,600 Hepatic: Bilirubin no greater than 1.5 times normal Renal: Creatinine no greater than 1.5 times normal Cardiovascular: No patients with severe heart failure requiring diuretics or an ejection fraction of less than 50% Neurological: No severe concomitant neurological disease PRIOR CONCURRENT THERAPY: Biologic therapy: No treatments within the past 4 weeks of: Biological response modifiers AND/OR Low dose Ara-C Chemotherapy: No prior intensive treatment for MDS or AML Endocrine therapy: Not specified Radiotherapy: No prior treatment for MDS or AML Surgery: Not specified
Sites / Locations
- Algemeen Ziekenhuis Middelheim
- A.Z. St. Jan
- Institut Jules Bordet
- Hopital Universitaire Erasme
- Cliniques Universitaires Saint-Luc
- Universitair Ziekenhuis Antwerpen
- U.Z. Gasthuisberg
- Clinique Universitaire De Mont-Godinne
- University Hospital Rebro
- Institute of Hematology and Blood Transfusion
- Hopital Edouard Herriot
- Centre Antoine Lacassagne
- Hotel Dieu de Paris
- Hopital Necker
- Universitaetsklinik Duesseldorf
- Universitaetsklinik und Strahlenklinik - Essen
- Medizinische Klinik und Poliklinik
- Klinikum Grosshadern
- Eberhard Karls Universitaet
- Ospedale San Eugenio
- Leyenburg Ziekenhuis
- Vrije Universiteit Medisch Centrum
- Onze Lieve Vrouwe Gasthuis
- Academisch Medisch Centrum
- Leiden University Medical Center
- Academisch Ziekenhuis Maastricht
- University Medical Center Nijmegen
- University Hospital - Rotterdam Dijkzigt
- Erasmus Medical Center
- Sophia Ziekehuis
- Sahlgrenska University Hospital
- University Hospital of Linkoping
- Orebro University Hospital
- Huddinge University Hospital
- University Hospital
- Ospedale San Giovanni
- Inselspital, Bern
- Hopital Cantonal Universitaire de Geneva
- Centre Hospitalier Universitaire Vaudois
- Kantonsspital - St. Gallen