Leukemia, Promyelocytic, Acute
Conditions
Keywords
acute promyelocytic leukemia, risk adapted therapy
Brief summary
In AIDA 2000 therapy of acute promyelocytic leukemia (APL) is given in a risk-adapted manner. Risk factors are age and white-blood-cell (WBC)-count at diagnosis. Induction therapy is done with ATRA and idarubicin followed by postremission therapy with daunorubicin and mitoxantrone in age adapted dosages. Patients with an high WBC were additionally treated with cytarabine. Finally a two year period of maintenance therapy with 6-mercaptopurine, methotrexate and ATRA is performed.
Detailed description
In AIDA 2000 therapy of acute promyelocytic leukemia (APL) is given in a risk-adapted manner. Risk factors are age and white-blood-cell (WBC)-count at diagnosis. Induction therapy is done with ATRA and idarubicin followed by postremission therapy with daunorubicin and mitoxantrone in age adapted dosages. Patients with an high WBC were additionally treated with cytarabine. Finally a two year period of maintenance therapy with 6-mercaptopurine, methotrexate and ATRA is performed.
Interventions
Sponsors
Technische Universität Dresden
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
16 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* acute promyelocytic leukemia confirmed by detection of t(15;17) and/or PML/RARa * no contraindication for chemotherapy * written informed consent
Exclusion criteria
\- severe comorbidities
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| overall survival | — |
Secondary
| Measure | Time frame |
|---|---|
| toxicity of the regimen | — |
| evaluation of additional risk factors | — |
| effectiveness of MRD as guidance for therapy decisions | — |
| relapse free survival | — |
| complete remission rate | — |
Countries
Germany
Contacts
Primary ContactMarkus Schaich, MD
Backup ContactSilke Soucek
Outcome results
None listed