A Randomized Phase III Study to Assess Intensification of the Conditioning Regimen for Allogenic Stem Cell Transplantation (ALLO-SCT) for Leukemia or Myelodysplastic Syndrome With a High Risk of Relapse
Sponsor study identifier
Secondary identifiers
interventional
207
5 countries
9
Study Start
March 1997
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
Not reported
Date not reportedStudy Completion
Not reported
Date not reportedRATIONALE: 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 idarubicin plus peripheral stem cell transplantation using the patient's own or donated stem cells in treating patients with leukemia or myelodysplastic syndrome.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
Not reported
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
March 1997
Date type not reportedThis date has not been verified as actual or estimated.
November 1, 1999
Actual (reported)November 25, 2003
Actual (reported)Institut Jules Bordet
Brussels (Bruxelles), 1000, Belgium
Hopital Edouard Herriot
Lyon, 69437, France
Hotel Dieu de Paris
Paris, 75181, France
Institut Gustave Roussy
Villejuif, F-94805, France
Eberhard Karls Universitaet
Tübingen, D-72076, Germany
Ospedale San Eugenio
Rome, 00144, Italy
Azienda Policlinico Umberto Primo
Rome, 00161, Italy
Theo De Witte, MD, PhD
Universitair Medisch Centrum St. Radboud - Nijmegen
First Submitted
November 1, 1999
First Posted
November 25, 2003
Study Start
March 1997
Date type not reportedThis date has not been verified as actual or estimated.
Last Updated
February 9, 2009
Record last verified: 2007-07
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Leiden University Medical Center
Leiden, 2300 CA, Netherlands
University Medical Center Nijmegen
Nijmegen, NL-6500 HB, Netherlands