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

Sponsor
University of Ulm (Other)
Overall Status
Completed
CT.gov ID
NCT00146120
Collaborator
(none)
400
Enrollment
22
Locations
84
Duration (Months)
18.2
Patients Per Site
0.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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 or DiseaseIntervention/TreatmentPhase
Phase 3

Study Design

Study Type:
Interventional
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Risk-Adapted Therapy of Acute Myeloid Leukemia of Adults (18-60 Years) According to the Cytogenetic Result
Study Start Date :
May 1, 1998
Actual Primary Completion Date :
May 1, 2005
Actual Study Completion Date :
May 1, 2005

Outcome Measures

Primary Outcome Measures

  1. relapse-free survival [two years]

Secondary Outcome Measures

  1. overall survival [two years]

Eligibility Criteria

Criteria

Ages Eligible for Study:
16 Years to 60 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Locations

SiteCityStateCountryPostal Code
1Department of Hematology / Oncology, University Hospital of InnsbruckInnsbruckAustria6020
2III Medical Department, Hematology and Oncology Center, Hanuschhospital WienWienAustria1140
3Department of General Internal Medicine, University Hospital of BonnBonnGermany53127
4Department of Internal Medicine Hematology, Heinrich-Heine UniversityDüsseldorfGermany40225
5Department of Interial Medicine III, City Hospital Frankfurt Am Main - HöchstFrankfurtGermany65927
6Medical Department IV, University of GießenGießenGermany35392
7Department of Interial Medicine, Wilhelm-Anton-Hospital GochGochGermany47574
8Centre of Interial Medicine, University of GöttingenGöttingenGermany37075
9Medical Department III of Hematology and Oncology, General Hospital AltonaHamburgGermany22763
10Department of Interial Medicine V, University of HeidelbergHeidelbergGermany69120
11Department of Interial Medicine I, University Hospital of SaarlandHomburgGermany66421
12Medical Department II, City Hospital Karlsruhe gGmbHKarlsruheGermany76133
13Medical Department II, University Hospital of KielKielGermany24116
14Department of Interial Medicine /Hematology and Oncology, Caritas Hospital LebachLebachGermany66822
15I. Medical Department, City Hospital München-SchwabingMünchenGermany80804
16Medical Department III, Clinical Center rechts der IsarMünchenGermany81675
17Department of Hematology and Oncology, City Hospital Neunkirchen gGmbHNeunkirchenGermany66538
18Department of Hematology and Oncology, Clinical Center of Oldenburg gGmbHOldenburgGermany26133
19Department of Hematologie and Oncology, Caritas Hospital St. Theresa SaarbrückenSaarbrückenGermany66113
20Clinikal Cetner of Stuttgart, Center of OncologyStuttgartGermany70174
21Medical Department I, Clinical Center of StuttgartStuttgartGermany70191
22Hospital of Barmherzige Brüder, I Medical DepartmentTrierGermany54292

Sponsors and Collaborators

  • University of Ulm

Investigators

  • Principal Investigator: Hartmut Döhner, Prof. Dr., University of Ulm

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
, ,
ClinicalTrials.gov Identifier:
NCT00146120
Other Study ID Numbers:
  • AMLHD98A
First Posted:
Sep 5, 2005
Last Update Posted:
Feb 9, 2009
Last Verified:
Dec 1, 2008

Study Results

No Results Posted as of Feb 9, 2009