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)

October 28, 2021 updated by: University Hospital Carl Gustav Carus

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)

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

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

143

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Aachen, Germany
        • Universitätsklinikum Aachen
      • Augsburg, Germany
        • Klinikum Augsburg
      • Chemnitz, Germany
        • Klinikum Chemnitz gGmbH
      • Dresden, Germany, 01307
        • University Hospital Carl Gustav Carus
      • Erlangen, Germany
        • Universitätsklinikum Erlangen
      • Essen, Germany
        • Universitätsklinikum Essen - Westdeutsches Tumorzentrum
      • Frankfurt am Main, Germany
        • Klinikum der Johann-Wolfgang-Goethe Universität
      • Frankfurt/Oder, Germany
        • Klinikum Frankfurt (Oder) GmbH
      • Halle / Saale, Germany
        • Universitätsklinikum Halle
      • Hamburg, Germany
        • Asklepios Klinik St. Georg
      • Leipzig, Germany
        • Universitaetsklinikum Leipzig - AöR
      • Magdeburg, Germany
        • Universitätsklinikum Magdeburg
      • Mannheim, Germany
        • Universitätsklinikum Mannheim
      • Marburg, Germany
        • Universitätsklinikum Gießen und Marburg GmbH
      • München, Germany
        • Klinikum der LMU Universität - Campus Großhadern
      • Münster, Germany
        • Universitätsklinikum Münster
      • Nürnberg, Germany
        • Städtisches Klinikum Nord
      • Potsdam, Germany
        • Ernst-von-Bergmann-Klinikum Potsdam
      • Stuttgart, Germany
        • Robert-Bosch-Krankenhaus

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percent of Patients alive after 4 years (Overall Survival)
Time Frame: 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.
4 years

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital Carl Gustav Carus

Collaborators

German Research Foundation

Investigators

  • Principal Investigator: Martin Bornhaeuser, Prof. (MD), Universitätsklinikum Dresden, Medizinische Klinik und Poliklinik I, Germany

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 10, 2011

Primary Completion (Actual)

April 30, 2020

Study Completion (Actual)

April 30, 2020

Study Registration Dates

First Submitted

November 22, 2010

First Submitted That Met QC Criteria

November 22, 2010

First Posted (Estimate)

November 23, 2010

Study Record Updates

Last Update Posted (Actual)

October 29, 2021

Last Update Submitted That Met QC Criteria

October 28, 2021

Last Verified

October 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TUD-ETAL-1-045

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Leukemia, Myeloid, Acute

Clinical Trials on Human Stem Cell Transplantation

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Saudi Arabia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe