Adult Acute Lymphocytic Leukemia
Conditions
Keywords
ALL, Treatment, De Novo, Adult
Brief summary
The study evaluates the efficacy and tolerability of a risk- and subtype-adapted chemotherapy over one year, followed by randomized either intensified or conventional maintenance therapy. It includes a distinct protocol for the subgroup 'mature B-ALL',
Interventions
DRUGAsparaginase
DRUGVincristine
DRUGDaunorubicin, Adriamycin
DRUGCyclophosphamide
DRUGIfosfamide
DRUGCytarabine
DRUGMitoxantrone
DRUGMethotrexate
DRUG6-Mercaptopurine
DRUG6-Thioguanine
DRUGVM26
PROCEDURECNS Irradiation
PROCEDUREMediastinal Irradiation
PROCEDUREStem Cell Transplantation
Sponsors
Deutsche Krebshilfe e.V., Bonn (Germany)
Goethe University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
15 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Acute Lymphocytic Leukemia * Age 15 - 65 years
Exclusion criteria
* Serious secondary diseases which may compromise intensified chemotherapeutical treatment * Serious psychiatric diseases, which may compromise compliance with therapy * HIV-1 or HIV-2 Infection * Pretreatment \> 2 weeks or chemotherapy other than Vincristine and Steroids * Patients without central diagnosis who cannot be allocated to a risk group
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| remission rate, disease free survival, overall survival | — |
Secondary
| Measure | Time frame |
|---|---|
| death in induction, toxicity, time and dose compliance | — |
Countries
Germany
Outcome results
None listed