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

Sponsor

Hannover Medical School (Other)

Overall Status

Unknown status

CT.gov ID

NCT00209833

Collaborator

University of Ulm (Other), Johann Wolfgang Goethe University Hospital (Other), University Hospital Freiburg (Other), University Hospital Augsburg (Other), Humboldt-Universität zu Berlin (Other), Universitätsklinikum Hamburg-Eppendorf (Other), University Hospital, Ghent (Other), Medizinische Universitätsklinik Tübingen (Other), Klinikum Hanover-Siloah Hospital (Other), Ev. Krankenhaus Essen-Werden (Other), Klinikum Wuppertal GmbH (Other)

200

Enrollment

Location

Duration (Months)

2.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
De Novo Akute Myeloid Leukemia (AML) Secondary Acute Myeloid Leukemia (AML) Refractory Anemia With Excess of Blasts in Transformation	Drug: Cytarabine Drug: Idarubicin Drug: Etoposide Drug: Fludarabine Drug: G-CSF Drug: Daunorubicine	Phase 2/Phase 3

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

Study Design

Study Type:

Interventional

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Protocol for the Treatment of Adults Aged </= 60 Years With De Novo Acute Myeloblastic Leukaemia or Secondary AML or RAEB-T (AML 01/99 Trial)

Study Start Date :

Jan 1, 1999

Study Completion Date :

Sep 1, 2005

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

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. []

Eligibility Criteria

Criteria

Ages Eligible for Study:

16 Years to 60 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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