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

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:

Genetics Home Reference related topics: familial acute myeloid leukemia with mutated CEBPA

MedlinePlus related topics: Acute Myeloid Leukemia Leukemia

Drug Information available for: Cytarabine

U.S. FDA Resources

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 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	Not yet 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: Jan Braess, Prof. Dr. med. jan.braess@med.uni-muenchen.de
Principal Investigator: Jan Braess, Prof. Dr. med.
Universitätsklinikum Münster	Recruiting
Münster, Germany
Contact: Matthias Stelljes, PD Dr. med. stelljes@uni-muenster.de
Principal Investigator: Matthias Stelljes, PD 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	Not yet 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

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 25, 2012
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 June 18, 2013