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

This study is currently recruiting participants.

Verified June 2012 by University Hospital Carl Gustav Carus

Sponsor:

Collaborator:

German Research Foundation

Information provided by (Responsible Party):

University Hospital Carl Gustav Carus

ClinicalTrials.gov Identifier:

NCT01246752

First received: November 22, 2010

Last updated: June 25, 2012

Last verified: June 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

November 22, 2010

Last Updated Date

June 25, 2012

Start Date ^ICMJE

November 2010

Estimated Primary Completion Date

December 2017 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Percent of Patients alive after 4 years (Overall Survival) [ Time Frame: 4 years ] [ Designated as safety issue: Yes ]

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

Overall Survival [ Time Frame: 4 years ] [ Designated as safety issue: Yes ]

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

Complete list of historical versions of study NCT01246752 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Disease-free survival [ Time Frame: 4 years ] [ Designated as safety issue: Yes ]
Cumulative incidence of relapse [ Time Frame: 4 years ] [ Designated as safety issue: Yes ]
Cumulative incidence of non-relapse mortality [ Time Frame: 4 years ] [ Designated as safety issue: Yes ]
Quality of life [ Time Frame: 4 years ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

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

Phase 3

Study Design ^ICMJE

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: 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 Arm (s)

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

Recruiting

Estimated Enrollment ^ICMJE

356

Estimated Completion Date

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

Gender

Both

Ages

18 Years to 60 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Martin Bornhaeuser, Prof. (MD)	+49 (0)351 458-0 ext -4190	martin.bornhaeuser@uniklinikum-dresden.de
Contact: Christoph Roellig, MD	+49 (0)351 458-0 ext -3775	christoph.roellig@uniklinikum-dresden.de

Location Countries ^ICMJE

Germany

Administrative Information

NCT Number ^ICMJE

NCT01246752

Other Study ID Numbers ^ICMJE

TUD-ETAL-1-045

Has Data Monitoring Committee

Yes

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

Information Provided By

University Hospital Carl Gustav Carus

Verification Date

June 2012

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

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