Trial record 14 of 848 for:    Open Studies | "Stem Cell Transplantation"

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.
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
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 - Westdeutsches Tumorzentrum Recruiting
Essen, Germany
Contact: Richard Noppeney, Dr. med.       richard.noppeney@uk-essen.de   
Principal Investigator: Richard Noppeney, 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.         
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, Acute
Leukemia, Myeloid
Neoplasms by Histologic Type
Neoplasms
Cytarabine
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Antiviral Agents
Anti-Infective Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on April 15, 2014