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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
Locations
Universitätsklinikum Aachen
Aachen, Germany
Status: Recruiting
Contact: Tim H Brümmendorf, Prof. Dr. med.
Klinikum Augsburg
Augsburg, Germany
Status: Recruiting
Contact: Günter Schlimok, Prof. Dr. med. - schlimok@klinikum-augsburg.de
Bielefeld Klinikum Mitte
Bielefeld, Germany
Status: Recruiting
Contact: Martin Görner, PD Dr. med. - martin.goerner@klinikumbielefeld.de
Klinikum Chemnitz gGmbH
Chemnitz, Germany
Status: Recruiting
Contact: Mathias Hänel, PD Dr. med. - m.haenel@skc.de
University Hospital Carl Gustav Carus
Dresden, Germany
Status: Recruiting
Contact: Martin Bornhäuser, Prof. Dr. - martin.bornhaeuser@uniklinikum-dresden.de
Universitätsklinikum Erlangen
Erlangen, Germany
Status: Recruiting
Contact: Wolf Rösler, Dr. med. - wolf.roesler@uk-erlangen.de
Universitätsklinikum Essen - Klinik für Knochenmarktransfusion
Essen, Germany
Status: Recruiting
Contact: Dietrich W Beelen, Prof. Dr. med. - dietrich.beelen@uk-essen.de
Universitätsklinikum Essen - Westdeutsches Tumorzentrum
Essen, Germany
Status: Recruiting
Contact: Richard Noppeney, Dr. med. - richard.noppeney@uk-essen.de
Klinikum der Johann-Wolfgang-Goethe Universität
Frankfurt am Main, Germany
Status: Recruiting
Contact: Gesine Bug, PD Dr. med. - g.bug@em.uni-frankfurt.de
Klinikum Frankfurt (Oder) GmbH
Frankfurt/Oder, Germany
Status: Recruiting
Contact: Michael Kiehl, Prof. Dr. med. - m.kiehl.km@klinikumffo.de
Ernst-Moritz-Arndt-Universitaet Greifswald
Greifswald, Germany
Status: Not yet recruiting
Contact: Gottfried Doelken, Prof. Dr. med. - doelken@uni-greifswald.de
Universitätsklinikum Halle
Halle / Saale, Germany
Status: Recruiting
Contact: Lutz P. Müller, Dr. med. - lutz.mueller@uk-halle.de
Asklepios Klinik St. Georg
Hamburg, Germany
Status: Recruiting
Contact: Norbert Schmitz, Prof. Dr. med. - n.schmitz@asklepios.com
Universitätsklinikum Heidelberg
Heidelberg, Germany
Status: Recruiting
Contact: Tilmann Bochtler, Dr. med.
Universitaetsklinikum Leipzig - AöR
Leipzig, Germany
Status: Recruiting
Contact: Dietger Niederwieser, Prof. Dr. med. - dietger@medizin.uni-leipzig.de
Universitätsklinikum Magdeburg
Magdeburg, Germany
Status: Recruiting
Contact: Thomas Heinicke, Dr. med. - thomas.heinicke@med.ovgu.de
Universitätsklinikum Mannheim
Mannheim, Germany
Status: Recruiting
Contact: Stefan Klein, PD Dr. med. - stefan.klein@umm.de
Universitätsklinikum Gießen und Marburg GmbH
Marburg, Germany
Status: Recruiting
Contact: Andreas Neubauer, Prof. Dr. med. - neubauer@staff.uni-marburg.de
Klinikum der LMU Universität - Campus Großhadern
München, Germany
Status: Recruiting
Contact: Johanna Tischer, Dr. med. - Johanna.Tischer@med.uni-muenchen.de
Universitätsklinikum Münster
Münster, Germany
Status: Recruiting
Contact: Matthias Stelljes, PD Dr. med. - stelljes@uni-muenster.de
Städtisches Klinikum Nord
Nürnberg, Germany
Status: Recruiting
Contact: Kerstin Schäfer-Eckart, Dr.med. - schaefer@klinikum-nuernberg.de
Ernst-von-Bergmann-Klinikum Potsdam
Potsdam, Germany
Status: Recruiting
Contact: Georg Maschmeyer, Prof. Dr. - gmaschmeyer@klinikumevb.de
Klinikum der Universität Regensburg
Regensburg, Germany
Status: Recruiting
Contact: Ernst Holler, Prof. Dr. med - ernst.holler@klinik.uni-regensburg.de
Robert-Bosch-Krankenhaus
Stuttgart, Germany
Status: Recruiting
Contact: Martin Kaufmann, Dr. med. - martin.kaufmann@rbk.de
Klinikum Mutterhaus der Borromäerinnen gGmbH
Trier, Germany
Status: Recruiting
Contact: Michael R Clemens, Prof. Dr. med. - clemens@mutterhaus.de
Dt. Klinik für Diagnostik
Wiesbaden, Germany
Status: Recruiting
Contact: Gernot Stuhler, PD Dr. med. - gernot.stuhler@dkd-wiesbaden.de
Universitätsklinikum Würzburg
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
https://clinicaltrials.gov/show/NCT01246752