De Novo Akute Myeloid Leukemia (AML), Secondary Acute Myeloid Leukemia (AML), Refractory Anemia With Excess of Blasts in Transformation
Conditions
Brief 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.
Detailed description
Assessment of the antileukemic activity and toxicity of the FLAG-Ida regimen as a second induction course in patients with bad response to the first induction cycle and/or with a high risk karyotype. Optimization of the late consolidation therapy in standard risk patients (SR) by a prospective randomized trial comparing a high-dose cytarabine/daunorubicin (HD-Ara-C/DNR) based late consolidation therapy with an autologous peripheral blood stem cell transplantation (PBSCT) Assessment of the antileukemic activity of the different treatment elements by monitoring residual disease (MRD) after induction, early and late consolidation by Real-time PCR Assessment of the prognostic relevance of minimal residual disease by quantification of the residual leukemic burden in haematological remission by Real-time PCR during follow-up
Interventions
Sponsors
University of Ulm
Johann Wolfgang Goethe University Hospital
University Hospital Freiburg
University Hospital Augsburg
Humboldt-Universität zu Berlin
Universitätsklinikum Hamburg-Eppendorf
University Hospital, Ghent
Medizinische Universitätsklinik Tübingen
Klinikum Hanover-Siloah Hospital
Ev. Krankenhaus Essen-Werden
Klinikum Wuppertal GmbH
Hannover Medical School
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
16 Years to 60 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Efficacy and toxicity of FLAG-Ida as second induction course in high risk patients. | — |
| Efficacy and toxicity of high-dose cytarabin/daunorubicin (HD-Ara-C/DNR) based late consolidation therapy vs. autologous peripheral blood stem cell transplantation in standard risk patients. | — |
Secondary
| Measure | Time frame |
|---|---|
| Monitoring residual disease (MRD) after induction, early and late consolidation by Real-time PCR. | — |
| Assessment of the prognostic relevance of minimal residual disease by quantification of minimal residual disease. | — |
Countries
Germany
Outcome results
None listed