Acute Myeloid Leukaemia
Conditions
Keywords
AML
Brief summary
Improvement of the treatment-results in elderly patients with acute myeloid leukemia through intensification of consolidation chemotherapy and/or allografting as consolidative immunotherapy
Detailed description
Measuring EFS depending on induction therapy
Interventions
DRUGCytarabine
Induction chemotherapy (1 or 2 courses): AraC 100 mg/m²/day i.v. 24h-infusion day 1-7 and Daunorubicin 60 mg/m² day 3+4+5. Consolidation chemotherapy (2 courses): AraC 1 g/m² i.v. 3h-infusion a 12h day 1+3+5.
BIOLOGICALhuman stem cells
Induction chemotherapy (1 or 2 courses): AraC 1 g/m² i.v. 3h-infusion a 12h day 1+3+5+7, Mitoxantrone 10 mg/m² day 1-3 and Pegfilgrastim 6 mg s.c. day 10. Consolidation chemotherapy (1 course): AraC 500 mg/m² i.v. 1h-infusion a 12h day 1+3+5, Mitoxantrone 10 mg/m² day 1+2 and Pegfilgrastim 6 mg s.c. day 8. Allogeneic stem cell transplantation using reduced intensity conditioning: Fludarabine 30 mg/m² day -4 - -2, TBI 200 cGy day 0; GvHD prophylaxis: cyclosporine A and mofetil mycofenolate
Sponsors
University of Leipzig
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
* Patients of both sexes with age \> 60 years and newly diagnosed acute myeloid leukaemia as defined by new WHO classification * written informed consent
Exclusion criteria
* pretreatment of leukemia * no informed consent * simultaneous inclusion in other studies * mental disability * contraindication for intensive chemotherapy * AML FAB M3 * contraindication for allogeneic stem cell transplantation * restriction of following organ functions: * creatinine-clearance \< 50 ml/min * cardiac ejection fraction \< 40 % * severe pulmonary restriction * bilirubin \> 2x ULN; SGOT and SGPT \> 4x ULN * uncontrolled hypertension * severe uncontrolled metabolism disturbance * Karnofsky-performance-score \< 70% * hepatitis C * other malignancy * age of unrelated donor \>70 years and age of related donor \>75 years
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Event free survival | after 5 years | comparison of event free survival (OSHO arm versus Standard intergroup arm) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| OS | at 5 years | Overall survival |
| LFS | at 5 years | leukemia free survival |
Countries
Germany
Outcome results
None listed