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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

Sponsor
University Hospital Carl Gustav Carus (Other)
Overall Status
Terminated
CT.gov ID
NCT01246752
Collaborator
German Research Foundation (Other)
143
Enrollment
19
Locations
2
Arms
110.6
Actual Duration (Months)
7.5
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

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

Condition or Disease Intervention/Treatment Phase
  • Biological: Human Stem Cell Transplantation
  • Drug: Consolidation chemotherapy, i.e. High-dose Cytarabine (HiDAC)
 Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
143 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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)
Actual Study Start Date :
Feb 10, 2011
Actual Primary Completion Date :
Apr 30, 2020
Actual Study Completion Date :
Apr 30, 2020

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. 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

  1. Disease-free survival [4 years]

  2. Cumulative incidence of relapse [4 years]

  3. Cumulative incidence of non-relapse mortality [4 years]

  4. 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)

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 60 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Universitätsklinikum Aachen Aachen Germany
2 Klinikum Augsburg Augsburg Germany
3 Klinikum Chemnitz gGmbH Chemnitz Germany
4 University Hospital Carl Gustav Carus Dresden Germany 01307
5 Universitätsklinikum Erlangen Erlangen Germany
6 Universitätsklinikum Essen - Westdeutsches Tumorzentrum Essen Germany
7 Klinikum der Johann-Wolfgang-Goethe Universität Frankfurt am Main Germany
8 Klinikum Frankfurt (Oder) GmbH Frankfurt/Oder Germany
9 Universitätsklinikum Halle Halle / Saale Germany
10 Asklepios Klinik St. Georg Hamburg Germany
11 Universitaetsklinikum Leipzig - AöR Leipzig Germany
12 Universitätsklinikum Magdeburg Magdeburg Germany
13 Universitätsklinikum Mannheim Mannheim Germany
14 Universitätsklinikum Gießen und Marburg GmbH Marburg Germany
15 Klinikum der LMU Universität - Campus Großhadern München Germany
16 Universitätsklinikum Münster Münster Germany
17 Städtisches Klinikum Nord Nürnberg Germany
18 Ernst-von-Bergmann-Klinikum Potsdam Potsdam Germany
19 Robert-Bosch-Krankenhaus Stuttgart Germany

Sponsors and Collaborators

  • University Hospital Carl Gustav Carus
  • German Research Foundation

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
University Hospital Carl Gustav Carus
ClinicalTrials.gov Identifier:
NCT01246752
Other Study ID Numbers:
  • TUD-ETAL-1-045
First Posted:
Nov 23, 2010
Last Update Posted:
Oct 29, 2021
Last Verified:
Oct 1, 2021
Keywords provided by University Hospital Carl Gustav Carus
AML, Leukemia
Acute Myeloid Leukemia
HSCT
Stem Cell Transplantation
Tx
Chemotherapy
Additional relevant MeSH terms:
Leukemia
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Cytarabine

Study Results

No Results Posted as of Oct 29, 2021