A Randomized, Risk and Age Adapted Comparison of the Dose-Dense Regimen S-HAM (Sequential High Dose Cytosine Arabinoside and Mitoxantrone) Versus Standard Double Induction for Initial Chemotherapy of Adult Patients With Acute Myeloid Leukemia
Inclusion Criteria:
- Patients with newly diagnosed AML (except acute promyelocytic leukemia) according to
the WHO classification including patients with secondary AML and AML after preceding
hematologic disorders
- Age 18 years or older
- Informed consent. Before any study specific procedure including randomisation is done
or before study medication is administered, the subject, or legally acceptable
representative, must have given written informed consent for participation in the
study.
Exclusion Criteria:
- Acute promyelocytic leukemia (APL)
- Previous or concurrent malignancies other than AML
- Previous treatment with colony-stimulating factors, interleukins or interferons
- Known hypersensitivity to Escherichia coli derived products (e.g. Filgrastim,
HUMULIN® Insulin, L-Asparaginase, HUMATROPE® Growth Hormone, INTRON A®)
- Antibody-based or cell-based immunotherapies
- Respiratory insufficiency with pO2 <60 mmHg
- Heart failure NYHA III° or IV°
- Elevated creatinine >2.0 mg/dl
- Elevated bilirubin >2.0 mg/dl
- Pregnancy or lactation
- Females without adequate contraception
- Known HIV and/or hepatitis C infection
- Severe neurologic or psychiatric disease
- Psychiatric, addictive, or any disorder, which compromises ability to give truly
informed consent for participation in this study
- Concerns for subject's compliance with the protocol procedures
- Lack of willingness to record and circulate personal disease-related informations
defined in the study protocol