Risk-Adapted Therapy of Acute Myeloid Leukemia of Adults (18-60 Years) According to the Cytogenetic Result

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. Identifier: NCT00146120
Recruitment Status : Completed
First Posted : September 5, 2005
Last Update Posted : February 9, 2009
Information provided by:
University of Ulm

September 1, 2005
September 5, 2005
February 9, 2009
May 1998
May 2005   (Final data collection date for primary outcome measure)
relapse-free survival [ Time Frame: two years ]
relapse-free survival
Complete list of historical versions of study NCT00146120 on Archive Site
overall survival [ Time Frame: two years ]
overall survival
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Risk-Adapted Therapy of Acute Myeloid Leukemia of Adults (18-60 Years) According to the Cytogenetic Result
Risk-Adapted Therapy of Acute Myeloid Leukemia of Adults (18-60 Years) According to the Cytogenetic Result
The concept of the investigators risk-adapted multicenter treatment trial for younger adults, AML HD98A, is based on the results of the AML HD93 trial and on published data. Definition of risk groups is different compared to the AML HD93 trial; high-risk: refractory disease after first induction therapy and/or high risk karyotype [abn(3q), -5/5q-, -7/7q-, abn(12p), abn(17p), complex]; intermediate-risk: complete remission after induction therapy and intermediate risk karyotype [normal, abn(11q23), abn(16q22), other rare aberrations]; low-risk: complete remission after induction therapy and low risk karyotype [t(8;21)]. Patients exhibiting a t(15;17) were treated in a separated trial (APL HD95). Treatment consists of a first induction therapy with ICE followed by a second cycle ICE in case of response to first induction therapy. Patients with refractory disease after first induction therapy are assigned to a salvage therapy with A-HAM (all-trans retinoic acid, high-dose cytarabine and mitoxantrone) and the search for potential hematopoietic stem cell donors is extended from the family to unrelated persons. All patients achieving a CR after induction therapy with ICE are assigned to a first consolidation therapy with HAM. For intermediate-risk patients a peripheral stem cell or a bone marrow harvest are intended during the hematological recovery after the first consolidation. Second consolidation therapy was stratified according to the risk definition. For high risk patients a allogeneic transplantation is assigned from a related or unrelated donor preferentially after a dose-intensified conditioning therapy. All patients with intermediate risk and an HLA-matched family donor are assigned to allogeneic transplantation. Intermediate-risk patients without a family donor and normal karyotype at diagnosis are randomized between an autologous stem cell transplantation and a second course of HAM. The other intermediate-risk patients are assigned to autologous transplantation. For low-risk patients a second course of HAM is assigned.
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Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Acute Myeloid Leukemia
  • Drug: Idarubicin
  • Drug: Cytosin-Arabinosid
  • Drug: Etoposide
  • Drug: All-trans Retinoid acid
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Same as current
May 2005
May 2005   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patients with AML, de Novo or secondary after Myelodysplasy, or with therapy-induced AML after healed primary malignom; or refractory anemia with excess of blasts in transformation (RAEB-t); the diagnosis must be confirmed morphological, cytochemical and with immunological phenotyping
  • Cytogenetical tests must be performed for each patient
  • Age: 16 - 60 years
  • All patients have to be informed about the character of the study. Written informed consent of each patient at study entry.

Exclusion Criteria:

  • Organic insufficiency: Insufficiency of the kidneys (Crea > 1.5 x upper normal serum level), or insufficiency of the liver (bilirubin, SGOT or AP > 2 x upper normal serum level) uncaused by the AML; severe obstruction or restrictive ventilation disorder, heart failure with a ejection fraction < 0.5
  • Secondary malignom
  • Other severe diseases
  • Pregnancy
  • Participation in an concurrent clinical study
Sexes Eligible for Study: All
16 Years to 60 Years   (Child, Adult)
Contact information is only displayed when the study is recruiting subjects
Austria,   Germany
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Prof. Dr. Reinhard Marre, University of Ulm
University of Ulm
Not Provided
Principal Investigator: Hartmut Döhner, Prof. Dr. Department of Internal Medicine III, University of Ulm
University of Ulm
December 2008

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