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

Primary Purpose

Leukemia, Myeloid, Acute

Status
Terminated
Phase
Phase 3
Locations
Germany
Study Type
Interventional
Intervention
Human Stem Cell Transplantation
Consolidation chemotherapy, i.e. High-dose Cytarabine (HiDAC)
Sponsored by
University Hospital Carl Gustav Carus
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Leukemia, Myeloid, Acute focused on measuring AML, Leukemia, Acute Myeloid Leukemia, HSCT, Stem Cell Transplantation, Tx, Chemotherapy

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Universitätsklinikum Aachen
  • Klinikum Augsburg
  • Klinikum Chemnitz gGmbH
  • University Hospital Carl Gustav Carus
  • Universitätsklinikum Erlangen
  • Universitätsklinikum Essen - Westdeutsches Tumorzentrum
  • Klinikum der Johann-Wolfgang-Goethe Universität
  • Klinikum Frankfurt (Oder) GmbH
  • Universitätsklinikum Halle
  • Asklepios Klinik St. Georg
  • Universitaetsklinikum Leipzig - AöR
  • Universitätsklinikum Magdeburg
  • Universitätsklinikum Mannheim
  • Universitätsklinikum Gießen und Marburg GmbH
  • Klinikum der LMU Universität - Campus Großhadern
  • Universitätsklinikum Münster
  • Städtisches Klinikum Nord
  • Ernst-von-Bergmann-Klinikum Potsdam
  • Robert-Bosch-Krankenhaus

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Human Stem Cell Transplantation

Consolidating Chemotherapy

Arm Description

Patients receive an allogenic stem cell transplantation from an HLA-matched unrelated or related donor

Patients receive a standard chemotherapy as consolidation therapy

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Disease-free survival
Cumulative incidence of relapse
Cumulative incidence of non-relapse mortality
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)

Full Information

First Posted
November 22, 2010
Last Updated
October 28, 2021
Sponsor
University Hospital Carl Gustav Carus
Collaborators
German Research Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT01246752
Brief Title
Haematopoietic Stem Cell Transplantation (HSCT) in Comparison to Conventional Consolidation Therapy for Patients With Acute Myeloid Leukemia (AML) (Intermediate Risk) </= 60y. After First CR
Acronym
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)
Study Type
Interventional

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Terminated
Why Stopped
decreased recrucial rate as the likelihood of achieving the envisioned patient number in a realistic time-frame was very low.
Study Start Date
February 10, 2011 (Actual)
Primary Completion Date
April 30, 2020 (Actual)
Study Completion Date
April 30, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital Carl Gustav Carus
Collaborators
German Research Foundation

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Leukemia, Myeloid, Acute
Keywords
AML, Leukemia, Acute Myeloid Leukemia, HSCT, Stem Cell Transplantation, Tx, Chemotherapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
143 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Human Stem Cell Transplantation
Arm Type
Experimental
Arm Description
Patients receive an allogenic stem cell transplantation from an HLA-matched unrelated or related donor
Arm Title
Consolidating Chemotherapy
Arm Type
Active Comparator
Arm Description
Patients receive a standard chemotherapy as consolidation therapy
Intervention Type
Biological
Intervention Name(s)
Human Stem Cell Transplantation
Intervention Description
Human allogenic stem cells
Intervention Type
Drug
Intervention Name(s)
Consolidation chemotherapy, i.e. High-dose Cytarabine (HiDAC)
Intervention Description
Consolidation chemotherapy, recommended regimen: HiDAC = 3 x 2g/sqm BID on days 1,3,5
Primary Outcome Measure Information:
Title
Percent of Patients alive after 4 years (Overall Survival)
Description
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.
Time Frame
4 years
Secondary Outcome Measure Information:
Title
Disease-free survival
Time Frame
4 years
Title
Cumulative incidence of relapse
Time Frame
4 years
Title
Cumulative incidence of non-relapse mortality
Time Frame
4 years
Title
Quality of life assessed by questionnaires
Description
Scores assessed by validated questionnaires (8 subscales: physical function, role physical, bodily pain, general health, vitality, social functioning, role emotional, mental health)
Time Frame
4 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Martin Bornhaeuser, Prof. (MD)
Organizational Affiliation
Universitätsklinikum Dresden, Medizinische Klinik und Poliklinik I, Germany
Official's Role
Principal Investigator
Facility Information:
Facility Name
Universitätsklinikum Aachen
City
Aachen
Country
Germany
Facility Name
Klinikum Augsburg
City
Augsburg
Country
Germany
Facility Name
Klinikum Chemnitz gGmbH
City
Chemnitz
Country
Germany
Facility Name
University Hospital Carl Gustav Carus
City
Dresden
ZIP/Postal Code
01307
Country
Germany
Facility Name
Universitätsklinikum Erlangen
City
Erlangen
Country
Germany
Facility Name
Universitätsklinikum Essen - Westdeutsches Tumorzentrum
City
Essen
Country
Germany
Facility Name
Klinikum der Johann-Wolfgang-Goethe Universität
City
Frankfurt am Main
Country
Germany
Facility Name
Klinikum Frankfurt (Oder) GmbH
City
Frankfurt/Oder
Country
Germany
Facility Name
Universitätsklinikum Halle
City
Halle / Saale
Country
Germany
Facility Name
Asklepios Klinik St. Georg
City
Hamburg
Country
Germany
Facility Name
Universitaetsklinikum Leipzig - AöR
City
Leipzig
Country
Germany
Facility Name
Universitätsklinikum Magdeburg
City
Magdeburg
Country
Germany
Facility Name
Universitätsklinikum Mannheim
City
Mannheim
Country
Germany
Facility Name
Universitätsklinikum Gießen und Marburg GmbH
City
Marburg
Country
Germany
Facility Name
Klinikum der LMU Universität - Campus Großhadern
City
München
Country
Germany
Facility Name
Universitätsklinikum Münster
City
Münster
Country
Germany
Facility Name
Städtisches Klinikum Nord
City
Nürnberg
Country
Germany
Facility Name
Ernst-von-Bergmann-Klinikum Potsdam
City
Potsdam
Country
Germany
Facility Name
Robert-Bosch-Krankenhaus
City
Stuttgart
Country
Germany

12. IPD Sharing Statement

Links:
URL
http://www.sal-aml.org
Description
Study Alliance Leukemia (coordinating study group)

Learn more about this 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

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