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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)


Phase 3
18 Years
60 Years
Open (Enrolling)
Both
Leukemia, Myeloid, Acute

Thank you

Trial Information

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)


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Percent of Patients alive after 4 years (Overall Survival)

Outcome 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.

Outcome Time Frame:

4 years

Safety Issue:

Yes

Principal Investigator

Martin Bornhaeuser, Prof. (MD)

Investigator Role:

Principal Investigator

Investigator Affiliation:

Universitätsklinikum Dresden, Medizinische Klinik und Poliklinik I, Germany

Authority:

Germany: Ethics Commission

Study ID:

TUD-ETAL-1-045

NCT ID:

NCT01246752

Start Date:

November 2010

Completion Date:

December 2017

Related Keywords:

  • Leukemia, Myeloid, Acute
  • AML, Leukemia
  • Acute Myeloid Leukemia
  • HSCT
  • Stem Cell Transplantation
  • Tx
  • Chemotherapy
  • Leukemia
  • Leukemia, Myeloid, Acute
  • Leukemia, Myeloid

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