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

This study has been completed.
Sponsor:
Information provided by:
University of Ulm
ClinicalTrials.gov Identifier:
NCT00146120
First received: September 1, 2005
Last updated: February 5, 2009
Last verified: December 2008
  Purpose

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.


Condition Intervention Phase
Acute Myeloid Leukemia
Drug: Idarubicin
Drug: Cytosin-Arabinosid
Drug: Etoposide
Drug: All-trans Retinoid acid
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Risk-Adapted Therapy of Acute Myeloid Leukemia of Adults (18-60 Years) According to the Cytogenetic Result

Resource links provided by NLM:


Further study details as provided by University of Ulm:

Primary Outcome Measures:
  • relapse-free survival [ Time Frame: two years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • overall survival [ Time Frame: two years ] [ Designated as safety issue: No ]

Estimated Enrollment: 400
Study Start Date: May 1998
Study Completion Date: May 2005
Primary Completion Date: May 2005 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   16 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00146120

Locations
Austria
Department of Hematology / Oncology, University Hospital of Innsbruck
Innsbruck, Austria, 6020
III Medical Department, Hematology and Oncology Center, Hanuschhospital Wien
Wien, Austria, 1140
Germany
Department of General Internal Medicine, University Hospital of Bonn
Bonn, Germany, 53127
Department of Internal Medicine Hematology, Heinrich-Heine University
Düsseldorf, Germany, 40225
Department of Interial Medicine III, City Hospital Frankfurt Am Main - Höchst
Frankfurt, Germany, 65927
Medical Department IV, University of Gießen
Gießen, Germany, 35392
Department of Interial Medicine, Wilhelm-Anton-Hospital Goch
Goch, Germany, 47574
Centre of Interial Medicine, University of Göttingen
Göttingen, Germany, 37075
Medical Department III of Hematology and Oncology, General Hospital Altona
Hamburg, Germany, 22763
Department of Interial Medicine V, University of Heidelberg
Heidelberg, Germany, 69120
Department of Interial Medicine I, University Hospital of Saarland
Homburg, Germany, 66421
Medical Department II, City Hospital Karlsruhe gGmbH
Karlsruhe, Germany, 76133
Medical Department II, University Hospital of Kiel
Kiel, Germany, 24116
Department of Interial Medicine /Hematology and Oncology, Caritas Hospital Lebach
Lebach, Germany, 66822
Medical Department III, Clinical Center rechts der Isar
München, Germany, 81675
I. Medical Department, City Hospital München-Schwabing
München, Germany, 80804
Department of Hematology and Oncology, City Hospital Neunkirchen gGmbH
Neunkirchen, Germany, 66538
Department of Hematology and Oncology, Clinical Center of Oldenburg gGmbH
Oldenburg, Germany, 26133
Department of Hematologie and Oncology, Caritas Hospital St. Theresa Saarbrücken
Saarbrücken, Germany, 66113
Clinikal Cetner of Stuttgart, Center of Oncology
Stuttgart, Germany, 70174
Medical Department I, Clinical Center of Stuttgart
Stuttgart, Germany, 70191
Hospital of Barmherzige Brüder, I Medical Department
Trier, Germany, 54292
Sponsors and Collaborators
University of Ulm
Investigators
Principal Investigator: Hartmut Döhner, Prof. Dr. Department of Internal Medicine III, University of Ulm
  More Information

Additional Information:
No publications provided by University of Ulm

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Prof. Dr. Reinhard Marre, University of Ulm
ClinicalTrials.gov Identifier: NCT00146120     History of Changes
Other Study ID Numbers: AMLHD98A
Study First Received: September 1, 2005
Last Updated: February 5, 2009
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Additional relevant MeSH terms:
Leukemia
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Neoplasms
Neoplasms by Histologic Type

ClinicalTrials.gov processed this record on October 29, 2014