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

Hannover Medical School (MHH)

Status and phase

Unknown

Phase 3

Phase 2

Conditions

Refractory Anemia With Excess of Blasts in Transformation

De Novo Akute Myeloid Leukemia (AML)

Secondary Acute Myeloid Leukemia (AML)

Treatments

Drug: Idarubicin

Drug: Fludarabine

Drug: G-CSF

Drug: Cytarabine

Drug: Etoposide

Drug: Daunorubicine

Study type

Interventional

Funder types

Other

Identifiers

NCT00209833

AML 01/99 trial

Details and patient eligibility

About

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.

Full 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

Sex

All

Ages

16 to 60 years old

Volunteers

No 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