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

Phase 3

Terminated

• Conditions: Leukemia, Myeloid, Acute
• Interventions: Biological: Human Stem Cell Transplantation; Drug: Consolidation chemotherapy, i.e. High-dose Cytarabine (HiDAC)

• Registration Number: NCT01246752
• Lead Sponsor: University Hospital Carl Gustav Carus

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-11-22
• Study First Submitted QC: 2010-11-22
• Study First Posted: 2010-11-23
• Study Start: 2011-02-10
• Primary Completion: 2020-04-30
• Study Completion: 2020-04-30
• Status Verified: 2021-10
• Last Update Submitted: 2021-10-28
• Last Update Posted: 2021-10-29

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 143

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Human Stem Cell Transplantation	Human Stem Cell Transplantation	Patients receive an allogenic stem cell transplantation from an HLA-matched unrelated or related donor
Consolidating Chemotherapy	Consolidation chemotherapy, i.e. High-dose Cytarabine (HiDAC)	Patients receive a standard chemotherapy as consolidation therapy

Primary Outcome Measures

Name	Time	Method
Percent of Patients alive after 4 years (Overall Survival)	4 years	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

Name	Time	Method
Cumulative incidence of non-relapse mortality	4 years
Quality of life assessed by questionnaires	4 years	Scores assessed by validated questionnaires (8 subscales: physical function, role physical, bodily pain, general health, vitality, social functioning, role emotional, mental health)
Disease-free survival	4 years
Cumulative incidence of relapse	4 years

Trial Locations

Locations (19)

Universitätsklinikum Aachen; 🇩🇪 Aachen, Germany

Klinikum Augsburg; 🇩🇪 Augsburg, Germany

Ernst-von-Bergmann-Klinikum Potsdam; 🇩🇪 Potsdam, Germany

Universitätsklinikum Münster; 🇩🇪 Münster, Germany

University Hospital Carl Gustav Carus; 🇩🇪 Dresden, Germany

Klinikum der Johann-Wolfgang-Goethe Universität; 🇩🇪 Frankfurt am Main, Germany

Klinikum Chemnitz gGmbH; 🇩🇪 Chemnitz, Germany

Universitätsklinikum Erlangen; 🇩🇪 Erlangen, Germany

Universitätsklinikum Essen - Westdeutsches Tumorzentrum; 🇩🇪 Essen, 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

Klinikum der LMU Universität - Campus Großhadern; 🇩🇪 München, Germany

Universitätsklinikum Gießen und Marburg GmbH; 🇩🇪 Marburg, Germany

Robert-Bosch-Krankenhaus; 🇩🇪 Stuttgart, Germany

Städtisches Klinikum Nord; 🇩🇪 Nürnberg, Germany