Overview

Treatment of Adults Aged Up to 60 Years With De Novo Acute Myeloblastic Leukaemia,Secondary AML, or RAEB-T

Status:
Unknown status
Trial end date:
2005-09-01
Target enrollment:
0
Participant gender:
All
Summary
This randomized phase II/III trial investigates the antileukemic activity and toxicity of the FLAG-Ida regimen as a second induction course in patients with acute myeloid leukaemia and bad response to the first induction cycle and/or with a high risk karyotype and compares the antileukemic activity and toxicity of high dose cytarabine/daunorubicin vs. autologous peripheral blood stem cell transplantation as late consolidation therapy in standard risk patients.
Phase:
Phase 2/Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Hannover Medical School
Collaborators:
Ev. Krankenhaus Essen-Werden
Humboldt-Universität zu Berlin
Johann Wolfgang Goethe University Hospital
Klinikum Augsburg
Klinikum Hanover-Siloah Hospital
Klinikum Wuppertal GmbH
Medizinische Universitätsklinik Tübingen
Universitätsklinikum Hamburg-Eppendorf
University Hospital Augsburg
University Hospital Freiburg
University Hospital, Ghent
University of Ulm
Treatments:
Cytarabine
Daunorubicin
Etoposide
Fludarabine
Idarubicin
Criteria
Inclusion Criteria:

- diagnosis of de-novo AML, FAB M 1, 2, 4 - 7

- diagnosis of secondary AML after chemo-/radiotherapy or MDS

- diagnosis of RAEB-T

- age between 16 and 60 years (including 60 years)

- women after exclusion of pregnancy

- written informed consent

Exclusion Criteria:

- patients with severe disease of the heart (e.g. cardial failure NYHA III/IV; history
of myocardial infarction within the last 6 months;severe ventricular arrythmias (Lown
III to IV)

- patients with DLCO < 50%

- patients with creatinine clearance < 60 ml/min

- patients with bilirubin > 2mg% (34.2 mmol/L)

- patients with severe complications of the leukaemia such as uncontrolled bleeding,
pneumonia with hypoxia or shock

- patients with a psychiatric, addictive, or any disorder which compromises ability to
give truly informed consent for participating in this study

- HIV positivity

- patients with a t(15;17) translocation