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

Technische Universität Dresden

Status and phase: Unknown; Phase 4

Conditions: Leukemia, Promyelocytic, Acute

Treatments: Drug: mitoxantrone; Drug: all-trans retinoid acid; Drug: daunorubicin; Drug: idarubicin; Drug: cytarabine

Study type: Interventional

Funder types: Other

Identifiers

NCT00180128

MK1-192

Details and patient eligibility

About

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.

Full 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.

Enrollment: 80 estimated patients

Sex: All

Ages: 16+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)