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Haematopoietic Stem Cell Transplantation (HSCT) in Comparison to Conventional Consolidation Therapy for Patients With Acute Myeloid Leukemia (AML) (Intermediate Risk) <= 60y. After First CR
Conditions
Leukemia, Myeloid, Acute
Conditions: official terms
Leukemia - Leukemia, Myeloid - Leukemia, Myeloid, Acute
Conditions: Keywords
AML, Leukemia, Acute Myeloid Leukemia, HSCT, Stem Cell Transplantation, Tx, Chemotherapy
Study Type
Interventional
Study Phase
Phase 3
Study Design
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: Human Stem Cell Transplantation
Type: Biological
Name: Consolidation chemotherapy, i.e. High-dose Cytarabine (HiDAC)
Type: Drug
Overall Status
Recruiting
Summary
Hematopoietic stem cell transplantation in patients with newly diagnosed AML ≤60 years of age in intermediate risk, after first complete response in comparison to standard consolidation chemotherapy
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: 60 Years
Minimum Age: 18 Years
Gender: Both
Criteria: Inclusion Criteria:
- AML in first remission
- cytological standard risk, i.e. karyotype not listed under exclusion criteria
- Identification of HLA-identical sibling or HLA-compatible related or unrelated donor (9/10 HLA-alleles matched, high resolution typing for HLA-A, B, Cw, DRB1 and DQB1)
- age: 18 - 60 years
- medically fit for allogeneic stem cell transplantation
- CR / CRi after induction therapy
Exclusion Criteria:
- core-binding factor leukemia (t(8;21), inv16)
- acute promyelocytic leukemia (t(15;17)
- complex aberrant karyotype
- karyotypes: -7; -5; del5q; t(3;3); t(6;11), t(6;9), 11q aberrations, trisomy 8 ± one single additional aberration
- pregnancy / nursing
- non-compliance
- AML in first remission
- cytological standard risk, i.e. karyotype not listed under exclusion criteria
- Identification of HLA-identical sibling or HLA-compatible related or unrelated donor (9/10 HLA-alleles matched, high resolution typing for HLA-A, B, Cw, DRB1 and DQB1)
- age: 18 - 60 years
- medically fit for allogeneic stem cell transplantation
- CR / CRi after induction therapy
Exclusion Criteria:
- core-binding factor leukemia (t(8;21), inv16)
- acute promyelocytic leukemia (t(15;17)
- complex aberrant karyotype
- karyotypes: -7; -5; del5q; t(3;3); t(6;11), t(6;9), 11q aberrations, trisomy 8 ± one single additional aberration
- pregnancy / nursing
- non-compliance
Locations
Universitätsklinikum Aachen
Aachen, Germany
Klinikum Augsburg
Status: Recruiting
Contact: Tim H Brümmendorf, Prof. Dr. med.
Augsburg, Germany
Bielefeld Klinikum Mitte
Status: Recruiting
Contact: Günter Schlimok, Prof. Dr. med. - schlimok@klinikum-augsburg.de
Bielefeld, Germany
Klinikum Chemnitz gGmbH
Status: Recruiting
Contact: Martin Görner, PD Dr. med. - martin.goerner@klinikumbielefeld.de
Chemnitz, Germany
University Hospital Carl Gustav Carus
Status: Recruiting
Contact: Mathias Hänel, PD Dr. med. - m.haenel@skc.de
Dresden, Germany
Universitätsklinikum Erlangen
Status: Recruiting
Contact: Martin Bornhäuser, Prof. Dr. - martin.bornhaeuser@uniklinikum-dresden.de
Erlangen, Germany
Universitätsklinikum Essen - Klinik für Knochenmarktransfusion
Status: Recruiting
Contact: Wolf Rösler, Dr. med. - wolf.roesler@uk-erlangen.de
Essen, Germany
Universitätsklinikum Essen - Westdeutsches Tumorzentrum
Status: Recruiting
Contact: Dietrich W Beelen, Prof. Dr. med. - dietrich.beelen@uk-essen.de
Essen, Germany
Klinikum der Johann-Wolfgang-Goethe Universität
Status: Recruiting
Contact: Richard Noppeney, Dr. med. - richard.noppeney@uk-essen.de
Frankfurt am Main, Germany
Klinikum Frankfurt (Oder) GmbH
Status: Recruiting
Contact: Gesine Bug, PD Dr. med. - g.bug@em.uni-frankfurt.de
Frankfurt/Oder, Germany
Ernst-Moritz-Arndt-Universitaet Greifswald
Status: Recruiting
Contact: Michael Kiehl, Prof. Dr. med. - m.kiehl.km@klinikumffo.de
Greifswald, Germany
Universitätsklinikum Halle
Status: Not yet recruiting
Contact: Gottfried Doelken, Prof. Dr. med. - doelken@uni-greifswald.de
Halle / Saale, Germany
Asklepios Klinik St. Georg
Status: Recruiting
Contact: Lutz P. Müller, Dr. med. - lutz.mueller@uk-halle.de
Hamburg, Germany
Universitätsklinikum Heidelberg
Status: Recruiting
Contact: Norbert Schmitz, Prof. Dr. med. - n.schmitz@asklepios.com
Heidelberg, Germany
Universitaetsklinikum Leipzig - AöR
Status: Recruiting
Contact: Tilmann Bochtler, Dr. med.
Leipzig, Germany
Universitätsklinikum Magdeburg
Status: Recruiting
Contact: Dietger Niederwieser, Prof. Dr. med. - dietger@medizin.uni-leipzig.de
Magdeburg, Germany
Universitätsklinikum Mannheim
Status: Recruiting
Contact: Thomas Heinicke, Dr. med. - thomas.heinicke@med.ovgu.de
Mannheim, Germany
Universitätsklinikum Gießen und Marburg GmbH
Status: Recruiting
Contact: Stefan Klein, PD Dr. med. - stefan.klein@umm.de
Marburg, Germany
Klinikum der LMU Universität - Campus Großhadern
Status: Recruiting
Contact: Andreas Neubauer, Prof. Dr. med. - neubauer@staff.uni-marburg.de
München, Germany
Universitätsklinikum Münster
Status: Recruiting
Contact: Johanna Tischer, Dr. med. - Johanna.Tischer@med.uni-muenchen.de
Münster, Germany
Städtisches Klinikum Nord
Status: Recruiting
Contact: Matthias Stelljes, PD Dr. med. - stelljes@uni-muenster.de
Nürnberg, Germany
Ernst-von-Bergmann-Klinikum Potsdam
Status: Recruiting
Contact: Kerstin Schäfer-Eckart, Dr.med. - schaefer@klinikum-nuernberg.de
Potsdam, Germany
Klinikum der Universität Regensburg
Status: Recruiting
Contact: Georg Maschmeyer, Prof. Dr. - gmaschmeyer@klinikumevb.de
Regensburg, Germany
Robert-Bosch-Krankenhaus
Status: Recruiting
Contact: Ernst Holler, Prof. Dr. med - ernst.holler@klinik.uni-regensburg.de
Stuttgart, Germany
Klinikum Mutterhaus der Borromäerinnen gGmbH
Status: Recruiting
Contact: Martin Kaufmann, Dr. med. - martin.kaufmann@rbk.de
Trier, Germany
Dt. Klinik für Diagnostik
Status: Recruiting
Contact: Michael R Clemens, Prof. Dr. med. - clemens@mutterhaus.de
Wiesbaden, Germany
Universitätsklinikum Würzburg
Status: Recruiting
Contact: Gernot Stuhler, PD Dr. med. - gernot.stuhler@dkd-wiesbaden.de
Würzburg, Germany
Status: Recruiting
Contact: Stephan Mielke, PD Dr. med. - mielke_s@klinik-wuerzburg.de
Start Date
November 2010
Completion Date
December 2017
Sponsors
University Hospital Carl Gustav Carus
Source
University Hospital Carl Gustav Carus
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page