AIDA2000 - Risk-Adapted Therapy for Patients With Acute Promyelocytic Leukemia

Leukemia, Promyelocytic, Acute Clinical Trial

Official title: AIDA2000 - Risk-Adapted Therapy for Patients With Acute Promyelocytic Leukemia(APL)

Status Recruiting

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Leukemia
• Leukemia, Promyelocytic, Acute

• NCT number: NCT00180128
• Study type: Interventional
• Source: Technische Universität Dresden
• Contact: Markus Schaich, MD
• Phone: +49-351-458
• Email: markus.schaich@uniklinikum-dresden.de
• Status: Recruiting
• Phase: Phase 4
• Start date: January 2000
• Completion date: November 2012