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
- 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.
Allocation: Randomized, Primary Purpose: Treatment
Theo De Witte, MD, PhD
Universitair Medisch Centrum St. Radboud - Nijmegen
United States: Federal Government