Clinical trial NCT01246752: Haematopoietic Stem Cell Transplantation (HSCT) in Comparison to Conventional Consolidation Therapy for Patients With Acute Myeloid Leukemia (AML) (Intermediate Risk) </= 60y. After First CR
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)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Leukemia, Myeloid, Acute
Keywords: AML, Leukemia
Acute Myeloid Leukemia
HSCT
Stem Cell Transplantation
Tx
Chemotherapy
Lead sponsor: University Hospital Carl Gustav Carus
Sponsor class: OTHER
Collaborators: name: German Research Foundation
First posted: 2010-11-23
Enrollment: 143
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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


Eligibility 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

Primary outcomes:
measure: Percent of Patients alive after 4 years (Overall Survival)
timeFrame: 4 years
Secondary outcomes:
measure: Disease-free survival
timeFrame: 4 years
measure: Cumulative incidence of relapse
timeFrame: 4 years
measure: Cumulative incidence of non-relapse mortality
timeFrame: 4 years
measure: Quality of life assessed by questionnaires
timeFrame: 4 years
Other outcomes:
Locations:
city: Aachen
country: Germany
facility: Universitätsklinikum Aachen
city: Augsburg
country: Germany
facility: Klinikum Augsburg
city: Chemnitz
country: Germany
facility: Klinikum Chemnitz gGmbH
city: Dresden
country: Germany
facility: University Hospital Carl Gustav Carus
city: Erlangen
country: Germany
facility: Universitätsklinikum Erlangen
city: Essen
country: Germany
facility: Universitätsklinikum Essen - Westdeutsches Tumorzentrum
city: Frankfurt am Main
country: Germany
facility: Klinikum der Johann-Wolfgang-Goethe Universität
city: Frankfurt/Oder
country: Germany
facility: Klinikum Frankfurt (Oder) GmbH
city: Halle / Saale
country: Germany
facility: Universitätsklinikum Halle
city: Hamburg
country: Germany
facility: Asklepios Klinik St. Georg
city: Leipzig
country: Germany
facility: Universitaetsklinikum Leipzig - AöR
city: Magdeburg
country: Germany
facility: Universitätsklinikum Magdeburg
city: Mannheim
country: Germany
facility: Universitätsklinikum Mannheim
city: Marburg
country: Germany
facility: Universitätsklinikum Gießen und Marburg GmbH
city: München
country: Germany
facility: Klinikum der LMU Universität - Campus Großhadern
city: Münster
country: Germany
facility: Universitätsklinikum Münster
city: Nürnberg
country: Germany
facility: Städtisches Klinikum Nord
city: Potsdam
country: Germany
facility: Ernst-von-Bergmann-Klinikum Potsdam
city: Stuttgart
country: Germany
facility: Robert-Bosch-Krankenhaus
Study officials:
affiliation: Universitätsklinikum Dresden, Medizinische Klinik und Poliklinik I, Germany
name: Martin Bornhaeuser, Prof. (MD)
role: PRINCIPAL_INVESTIGATOR
References: