Haematopoietic Stem Cell Transplantation (HSCT) in Comparison to Conventional Consolidation Therapy for Patients With Acute Myeloid Leukemia (AML) (Intermediate Risk) <= 60y. After First CR

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2013 by University Hospital Carl Gustav Carus
Sponsor:
Collaborator:
German Research Foundation
Information provided by (Responsible Party):
University Hospital Carl Gustav Carus
ClinicalTrials.gov Identifier:
NCT01246752
First received: November 22, 2010
Last updated: June 19, 2013
Last verified: June 2013
  Purpose

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


Condition Intervention Phase
Leukemia, Myeloid, Acute
Biological: Human Stem Cell Transplantation
Drug: Consolidation chemotherapy, i.e. High-dose Cytarabine (HiDAC)
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Randomised Trial on Allogeneic Haematopoietic Stem Cell Transplantation in Patients Under the Age of 60 Years With Acute Myeloid Leukemia of Intermediate Risk in First Complete Remission and a Matched Sibling or Unrelated Donor (ETAL-1)

Resource links provided by NLM:


Further study details as provided by University Hospital Carl Gustav Carus:

Primary Outcome Measures:
  • Percent of Patients alive after 4 years (Overall Survival) [ Time Frame: 4 years ] [ Designated as safety issue: Yes ]
    The status of each patient alive/not alive is surveyed every 3 months in year 1+2 and every 6 months in year 3+4 after randomisation.


Secondary Outcome Measures:
  • Disease-free survival [ Time Frame: 4 years ] [ Designated as safety issue: Yes ]
  • Cumulative incidence of relapse [ Time Frame: 4 years ] [ Designated as safety issue: Yes ]
  • Cumulative incidence of non-relapse mortality [ Time Frame: 4 years ] [ Designated as safety issue: Yes ]
  • Quality of life [ Time Frame: 4 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 356
Study Start Date: November 2010
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Human Stem Cell Transplantation
Patients receive an allogenic stem cell transplantation from an HLA-matched unrelated or related donor
Biological: Human Stem Cell Transplantation
Human allogenic stem cells
Active Comparator: Consolidating Chemotherapy
Patients receive a standard chemotherapy as consolidation therapy
Drug: Consolidation chemotherapy, i.e. High-dose Cytarabine (HiDAC)
Consolidation chemotherapy, recommended regimen: HiDAC = 3 x 2g/sqm BID on days 1,3,5

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01246752

Contacts
Contact: Martin Bornhaeuser, Prof. (MD) +49 (0)351 458-0 ext -4190 martin.bornhaeuser@uniklinikum-dresden.de
Contact: Christoph Roellig, MD +49 (0)351 458-0 ext -3775 christoph.roellig@uniklinikum-dresden.de

Locations
Germany
Universitätsklinikum Aachen Recruiting
Aachen, Germany
Contact: Tim H Brümmendorf, Prof. Dr. med.         
Principal Investigator: Tim H Brümmendorf, Prof. Dr. med.         
Klinikum Augsburg Recruiting
Augsburg, Germany
Contact: Günter Schlimok, Prof. Dr. med.       schlimok@klinikum-augsburg.de   
Principal Investigator: Günter Schlimok, Prof. Dr. med.         
Bielefeld Klinikum Mitte Recruiting
Bielefeld, Germany
Contact: Martin Görner, PD Dr. med.       martin.goerner@klinikumbielefeld.de   
Contact: Juliane Wopp, MD       Juliane.Wopp@klinikumbielefeld.de   
Principal Investigator: Martin Görner, PD Dr. med.         
Klinikum Chemnitz gGmbH Recruiting
Chemnitz, Germany
Contact: Mathias Hänel, PD Dr. med.       m.haenel@skc.de   
Principal Investigator: Mathias Hänel, PD Dr. med.         
University Hospital Carl Gustav Carus Recruiting
Dresden, Germany, 01307
Contact: Martin Bornhäuser, Prof. Dr.       martin.bornhaeuser@uniklinikum-dresden.de   
Principal Investigator: Martin Bornhäuser, Prof. Dr.         
Universitätsklinikum Erlangen Recruiting
Erlangen, Germany
Contact: Wolf Rösler, Dr. med.       wolf.roesler@uk-erlangen.de   
Principal Investigator: Wolf Rösler, Dr. med.         
Universitätsklinikum Essen - Klinik für Knochenmarktransfusion Recruiting
Essen, Germany
Contact: Dietrich W Beelen, Prof. Dr. med.       dietrich.beelen@uk-essen.de   
Principal Investigator: Dietrich W Beelen, Prof. Dr. med.         
Universitätsklinikum Essen - Westdeutsches Tumorzentrum Recruiting
Essen, Germany
Contact: Richard Noppeney, Dr. med.       richard.noppeney@uk-essen.de   
Principal Investigator: Richard Noppeney, Dr. med         
Klinikum der Johann-Wolfgang-Goethe Universität Recruiting
Frankfurt am Main, Germany
Contact: Gesine Bug, PD Dr. med.       g.bug@em.uni-frankfurt.de   
Principal Investigator: Gesine Bug, PD Dr. med.         
Klinikum Frankfurt (Oder) GmbH Recruiting
Frankfurt/Oder, Germany
Contact: Michael Kiehl, Prof. Dr. med.       m.kiehl.km@klinikumffo.de   
Principal Investigator: Michael Kiehl, Prof. Dr. med.         
Ernst-Moritz-Arndt-Universitaet Greifswald Not yet recruiting
Greifswald, Germany
Contact: Gottfried Doelken, Prof. Dr. med.       doelken@uni-greifswald.de   
Principal Investigator: Gottfried Doelken, Prof. Dr. med.         
Universitätsklinikum Halle Recruiting
Halle / Saale, Germany
Contact: Lutz P. Müller, Dr. med.       lutz.mueller@uk-halle.de   
Principal Investigator: Lutz P. Müller, Dr. med.         
Asklepios Klinik St. Georg Recruiting
Hamburg, Germany
Contact: Norbert Schmitz, Prof. Dr. med.       n.schmitz@asklepios.com   
Principal Investigator: Norbert Schmitz, Prof. Dr. med.         
Universitätsklinikum Heidelberg Recruiting
Heidelberg, Germany
Contact: Tilmann Bochtler, Dr. med.         
Principal Investigator: Tilmann Bochtler, Dr. med.         
Universitaetsklinikum Leipzig - AöR Recruiting
Leipzig, Germany
Contact: Dietger Niederwieser, Prof. Dr. med.       dietger@medizin.uni-leipzig.de   
Principal Investigator: Dietger Niederwieser, Prof. Dr. med.         
Universitätsklinikum Magdeburg Recruiting
Magdeburg, Germany
Contact: Thomas Heinicke, Dr. med.       thomas.heinicke@med.ovgu.de   
Principal Investigator: Thomas Heinicke, Dr. med.         
Universitätsklinikum Mannheim Recruiting
Mannheim, Germany
Contact: Stefan Klein, PD Dr. med.       stefan.klein@umm.de   
Principal Investigator: Stefan Klein, PD Dr. med.         
Universitätsklinikum Gießen und Marburg GmbH Recruiting
Marburg, Germany
Contact: Andreas Neubauer, Prof. Dr. med.       neubauer@staff.uni-marburg.de   
Principal Investigator: Andreas Neubauer, Prof. Dr. med.         
Klinikum der LMU Universität - Campus Großhadern Recruiting
München, Germany
Contact: Johanna Tischer, Dr. med.       Johanna.Tischer@med.uni-muenchen.de   
Principal Investigator: Johanna Tischer, Dr. med.         
Universitätsklinikum Münster Recruiting
Münster, Germany
Contact: Matthias Stelljes, PD Dr. med.       stelljes@uni-muenster.de   
Principal Investigator: Matthias Stelljes, Prof. Dr. med.         
Städtisches Klinikum Nord Recruiting
Nürnberg, Germany
Contact: Kerstin Schäfer-Eckart, Dr.med.       schaefer@klinikum-nuernberg.de   
Principal Investigator: Kerstin Schäfer-Eckart, Dr.med.         
Ernst-von-Bergmann-Klinikum Potsdam Recruiting
Potsdam, Germany
Contact: Georg Maschmeyer, Prof. Dr.       gmaschmeyer@klinikumevb.de   
Principal Investigator: Georg Maschmeyer, Prof. Dr.         
Klinikum der Universität Regensburg Recruiting
Regensburg, Germany
Contact: Ernst Holler, Prof. Dr. med       ernst.holler@klinik.uni-regensburg.de   
Principal Investigator: Ernst Holler, Prof. Dr. med         
Robert-Bosch-Krankenhaus Recruiting
Stuttgart, Germany
Contact: Martin Kaufmann, Dr. med.       martin.kaufmann@rbk.de   
Principal Investigator: Martin Kaufmann, Dr. med.         
Klinikum Mutterhaus der Borromäerinnen gGmbH Recruiting
Trier, Germany
Contact: Michael R Clemens, Prof. Dr. med.       clemens@mutterhaus.de   
Principal Investigator: Michael R Clemens, Prof. Dr. med.         
Dt. Klinik für Diagnostik Recruiting
Wiesbaden, Germany
Contact: Rainer Schwerdtfeger, PD Dr. med.       schwerdtfeger.kmt@dkd-wiesbaden.de   
Principal Investigator: Rainer Schwerdtfeger, PD Dr. med.         
Universitätsklinikum Würzburg Recruiting
Würzburg, Germany
Contact: Gernot Stuhler, PD Dr. med.       Stuhler_G@medizin.uni-wuerzburg.de   
Principal Investigator: Gernot Stuhler, PD Dr. med.         
Sponsors and Collaborators
University Hospital Carl Gustav Carus
German Research Foundation
Investigators
Principal Investigator: Martin Bornhaeuser, Prof. (MD) Universitätsklinikum Dresden, Medizinische Klinik und Poliklinik I, Germany
  More Information

Additional Information:
No publications provided

Responsible Party: University Hospital Carl Gustav Carus
ClinicalTrials.gov Identifier: NCT01246752     History of Changes
Other Study ID Numbers: TUD-ETAL-1-045
Study First Received: November 22, 2010
Last Updated: June 19, 2013
Health Authority: Germany: Ethics Commission
Germany: Paul-Ehrlich-Institut

Keywords provided by University Hospital Carl Gustav Carus:
AML, Leukemia
Acute Myeloid Leukemia
HSCT
Stem Cell Transplantation
Tx
Chemotherapy

Additional relevant MeSH terms:
Leukemia
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Neoplasms
Neoplasms by Histologic Type

ClinicalTrials.gov processed this record on October 23, 2014