Acute Myeloid Leukemia
Conditions
Brief summary
Evaluation weather early chemotherapy attempts for remission induction can improve the results of patients with Acute Myeloid Leukemia (AML), as compared to the standard group.
Interventions
DRUGAra-C, Mitoxantrone, Daunorubicin, Thioguanin
Chemotherapy
Sponsors
Kompetenznetz Leukämien
Prof. Dr. Wolfgang Hiddemann
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall response rate, aiming at a 15% increase in the CR/PR rate by S-HAM induction versus conventional double induction [TAD - HAM for younger patients, HAM (- HAM) for elderly patients]. | 8 years |
Countries
Germany
Outcome results
None listed