Spots Global Cancer Trial Database for Combination Chemotherapy With or Without Peripheral Stem Cell Transplantation in Treating Patients With Myelodysplastic Syndrome or Acute Myelogenous Leukemia
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Trial Identification
Brief Title: Combination Chemotherapy With or Without Peripheral Stem Cell Transplantation in Treating Patients With Myelodysplastic Syndrome or Acute Myelogenous Leukemia
Official Title: 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
Study ID: NCT00002926
Study Description
Brief Summary: RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining chemotherapy with peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells. PURPOSE: Randomized phase III trial to compare the effectiveness of peripheral stem cell transplantation with high-dose cytarabine in treating patients with myelodysplastic syndrome or acute myelogenous leukemia.
Detailed Description: 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.
Keywords
Eligibility
Minimum Age: 16 Years
Eligible Ages: CHILD, ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Algemeen Ziekenhuis Middelheim, Antwerp, , Belgium
A.Z. St. Jan, Brugge, , Belgium
Institut Jules Bordet, Brussels, , Belgium
Hopital Universitaire Erasme, Brussels, , Belgium
Cliniques Universitaires Saint-Luc, Brussels, , Belgium
Universitair Ziekenhuis Antwerpen, Edegem, , Belgium
U.Z. Gasthuisberg, Leuven, , Belgium
Clinique Universitaire De Mont-Godinne, Mont-Godinne Yvoir, , Belgium
University Hospital Rebro, Zagreb, , Croatia
Institute of Hematology and Blood Transfusion, Prague, , Czech Republic
Hopital Edouard Herriot, Lyon, , France
Centre Antoine Lacassagne, Nice, , France
Hotel Dieu de Paris, Paris, , France
Hopital Necker, Paris, , France
Universitaetsklinik Duesseldorf, Duesseldorf, , Germany
Universitaetsklinik und Strahlenklinik - Essen, Essen, , Germany
Medizinische Klinik und Poliklinik, Heidelberg, , Germany
Klinikum Grosshadern, Munich (Muenchen), , Germany
Eberhard Karls Universitaet, Tuebingen, , Germany
Ospedale San Eugenio, Rome, , Italy
Leyenburg Ziekenhuis, 's-Gravenhage, , Netherlands
Vrije Universiteit Medisch Centrum, Amsterdam, , Netherlands
Onze Lieve Vrouwe Gasthuis, Amsterdam, , Netherlands
Academisch Medisch Centrum, Amsterdam, , Netherlands
Leiden University Medical Center, Leiden, , Netherlands
Academisch Ziekenhuis Maastricht, Maastricht, , Netherlands
University Medical Center Nijmegen, Nijmegen, , Netherlands
University Hospital - Rotterdam Dijkzigt, Rotterdam, , Netherlands
Erasmus Medical Center, Rotterdam, , Netherlands
Sophia Ziekehuis, Zwolle, , Netherlands
Sahlgrenska University Hospital, Gothenburg (Goteborg), , Sweden
University Hospital of Linkoping, Linkoping, , Sweden
Orebro University Hospital, Orebro, , Sweden
Huddinge University Hospital, Stockholm, , Sweden
University Hospital, Basel, , Switzerland
Ospedale San Giovanni, Bellinzona, , Switzerland
Inselspital, Bern, Bern, , Switzerland
Hopital Cantonal Universitaire de Geneva, Geneva, , Switzerland
Centre Hospitalier Universitaire Vaudois, Lausanne, , Switzerland
Kantonsspital - St. Gallen, St. Gallen, , Switzerland
Contact Details
Name: Theo De Witte, MD, PhD
Affiliation: Universitair Medisch Centrum St. Radboud - Nijmegen
Role: STUDY_CHAIR
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