Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01246752
Recruitment Status : Unknown
Verified December 2014 by University Hospital Carl Gustav Carus.
Recruitment status was:  Recruiting
First Posted : November 23, 2010
Last Update Posted : December 3, 2014
Sponsor:
Collaborator:
German Research Foundation
Information provided by (Responsible Party):
University Hospital Carl Gustav Carus

Tracking Information
First Submitted Date  ICMJE November 22, 2010
First Posted Date  ICMJE November 23, 2010
Last Update Posted Date December 3, 2014
Study Start Date  ICMJE November 2010
Estimated Primary Completion Date December 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 19, 2011)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: November 22, 2010)
Overall Survival [ Time Frame: 4 years ]
To define the role of allogeneic stem cell transplantation in patients ≤60 years with intermediate-risk acute myeloid leukemia in first complete remission. According to the primary hypothesis, four years after randomisation, a 15% survival advantage of allogeneic stem cell transplantation (60% vs. 45%) compared to conventional postremission therapy is assumed.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 22, 2010)
  • Disease-free survival [ Time Frame: 4 years ]
  • Cumulative incidence of relapse [ Time Frame: 4 years ]
  • Cumulative incidence of non-relapse mortality [ Time Frame: 4 years ]
  • Quality of life [ Time Frame: 4 years ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Haematopoietic Stem Cell Transplantation (HSCT) in Comparison to Conventional Consolidation Therapy for Patients With Acute Myeloid Leukemia (AML) (Intermediate Risk) <= 60y. After First CR
Official Title  ICMJE 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)
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Leukemia, Myeloid, Acute
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • Experimental: Human Stem Cell Transplantation
    Patients receive an allogenic stem cell transplantation from an HLA-matched unrelated or related donor
    Intervention: Biological: Human Stem Cell Transplantation
  • Active Comparator: Consolidating Chemotherapy
    Patients receive a standard chemotherapy as consolidation therapy
    Intervention: Drug: Consolidation chemotherapy, i.e. High-dose Cytarabine (HiDAC)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: November 22, 2010)
356
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2017
Estimated Primary Completion Date December 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01246752
Other Study ID Numbers  ICMJE TUD-ETAL-1-045
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University Hospital Carl Gustav Carus
Study Sponsor  ICMJE University Hospital Carl Gustav Carus
Collaborators  ICMJE German Research Foundation
Investigators  ICMJE
Principal Investigator: Martin Bornhaeuser, Prof. (MD) Universitätsklinikum Dresden, Medizinische Klinik und Poliklinik I, Germany
PRS Account University Hospital Carl Gustav Carus
Verification Date December 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP