AIDA2000 - Risk-Adapted Therapy for Patients With Acute Promyelocytic Leukemia
Conditions
Leukemia, Promyelocytic, Acute
Conditions: official terms
Leukemia - Leukemia, Promyelocytic, Acute
Conditions: Keywords
acute promyelocytic leukemia, risk adapted therapy
Study Type
Interventional
Study Phase
Phase 4
Study Design
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention
Intervention
Name: all-trans retinoid acid Type: Drug
Name: idarubicin Type: Drug
Name: mitoxantrone Type: Drug
Name: daunorubicin Type: Drug
Name: cytarabine Type: Drug
Overall Status
Recruiting
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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 16 Years
Gender: Both
Criteria: 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
Location
Department of Medicine I, University Hospital Carl Gustav Carus
Dresden, Germany
Status: Recruiting
Contact: Markus Schaich, MD - +49-351-458 - markus.schaich@uniklinikum-dresden.de
Start Date
January 2000
Completion Date
November 2012
Sponsors
Technische Universität Dresden
Source
Technische Universität Dresden
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page