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NCT01246752 Clinical Trial

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

Leukemia, Myeloid, Acute Clinical Trial

— AML  

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)

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT01246752
Other study ID # TUD-ETAL-1-045
Secondary ID
Status Terminated
Phase Phase 3
First received
Last updated
Start date February 10, 2011
Est. completion date April 30, 2020

Study information
Verified date October 2021
Source University Hospital Carl Gustav Carus
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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

Recruitment information / eligibility
Status Terminated
Enrollment 143
Est. completion date April 30, 2020
Est. primary completion date April 30, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years to 60 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Biological:
• Human Stem Cell Transplantation
Human allogenic stem cells
Drug:
• Consolidation chemotherapy, i.e. High-dose Cytarabine (HiDAC)
Consolidation chemotherapy, recommended regimen: HiDAC = 3 x 2g/sqm BID on days 1,3,5

Locations
Country Name City State
Germany Universitätsklinikum Aachen Aachen
Germany Klinikum Augsburg Augsburg
Germany Klinikum Chemnitz gGmbH Chemnitz
Germany University Hospital Carl Gustav Carus Dresden
Germany Universitätsklinikum Erlangen Erlangen
Germany Universitätsklinikum Essen - Westdeutsches Tumorzentrum Essen
Germany Klinikum der Johann-Wolfgang-Goethe Universität Frankfurt am Main
Germany Klinikum Frankfurt (Oder) GmbH Frankfurt/Oder
Germany Universitätsklinikum Halle Halle / Saale
Germany Asklepios Klinik St. Georg Hamburg
Germany Universitaetsklinikum Leipzig - AöR Leipzig
Germany Universitätsklinikum Magdeburg Magdeburg
Germany Universitätsklinikum Mannheim Mannheim
Germany Universitätsklinikum Gießen und Marburg GmbH Marburg
Germany Klinikum der LMU Universität - Campus Großhadern München
Germany Universitätsklinikum Münster Münster
Germany Städtisches Klinikum Nord Nürnberg
Germany Ernst-von-Bergmann-Klinikum Potsdam Potsdam
Germany Robert-Bosch-Krankenhaus Stuttgart

Sponsors (2)
Lead Sponsor Collaborator
University Hospital Carl Gustav Carus German Research Foundation

Country where clinical trial is conducted

Germany, 

Outcome
Type Measure Description Time frame Safety issue
Primary Percent of Patients alive after 4 years (Overall Survival) 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. 4 years
Secondary Disease-free survival 4 years
Secondary Cumulative incidence of relapse 4 years
Secondary Cumulative incidence of non-relapse mortality 4 years
Secondary Quality of life assessed by questionnaires Scores assessed by validated questionnaires (8 subscales: physical function, role physical, bodily pain, general health, vitality, social functioning, role emotional, mental health) 4 years
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