AIDA2000 - Risk-Adapted Therapy for Patients With Acute Promyelocytic Leukemia
- Conditions
- Leukemia, Promyelocytic, Acute
- Registration Number
- NCT00180128
- Lead Sponsor
- Technische Universität Dresden
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 80
- acute promyelocytic leukemia confirmed by detection of t(15;17) and/or PML/RARa
- no contraindication for chemotherapy
- written informed consent
- severe comorbidities
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method overall survival
- Secondary Outcome Measures
Name Time Method toxicity of the regimen evaluation of additional risk factors effectiveness of MRD as guidance for therapy decisions relapse free survival complete remission rate
Trial Locations
- Locations (1)
Department of Medicine I, University Hospital Carl Gustav Carus
🇩🇪Dresden, Germany