Autologous Peripheral Blood Stem Cell Transplantation (PSCT) Versus a Second Intensive Consolidation Course After a Common Induction and Consolidation Course in Patients With Bad Prognosis Myelodysplastic Syndromes (MDS) and Acute Myelogenous Leukemia Secondary (SAML) to MDS of More Acute Than 6 Months Duration
cytarabine
+ etoposide
+ idarubicin
Anemia+14
+ Bone Marrow Diseases
+ Chronic Disease
Treatment Study
Summary
Study start date: December 1, 1996
Actual date on which the first participant was enrolled.OBJECTIVES: Assess the value of autologous peripheral stem cell transplantation versus high dose cytarabine (Ara-C) performed after a common induction and consolidation course in patients with poor prognosis myelodysplastic syndromes (MDS) or acute myelogenous leukemia secondary to MDS. Compare the disease free survival and overall survival of patients who reached complete recovery according to the presence of an HLA-identical donor. Monitor cytogenetic and clonal remission after intensive antileukemic therapy including stem cell transplantation. Monitor residual disease and the hematopoietic clonal status of autologous peripheral blood stem cells mobilized after one consolidation course. Assess recovery time of granulocyte and platelet counts following each treatment step. OUTLINE: Induction treatment with idarubicin on days 1,3,5; Ara-C from days 1 through 10; etoposide on days 1 through 5. On day 28 there will be assessment of responses. If there is at least partial response, the cycle will repeat the induction course for another 28 days. There is peripheral blood stem cell collection and cryopreservation following family HLA-typing. If there is no HLA match, then those who remained in remission after these consolidation courses will be randomized to either peripheral blood stem cell transplantation or HiDAC treatment. PROJECTED ACCRUAL: 80 patients will be entered per year.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.80 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.From 16 to 60 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
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
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 40 locations
A.Z. St. Jan
Bruges, BelgiumInstitut Jules Bordet
Brussels, BelgiumHopital Universitaire Erasme
Brussels, Belgium