AIDA2000 - Risk-Adapted Therapy for Patients With Acute Promyelocytic Leukemia
NCT00180128 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 80
Last updated 2011-07-11
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.
Conditions
- Leukemia, Promyelocytic, Acute
Interventions
- DRUG
-
all-trans retinoid acid
- DRUG
-
idarubicin
- DRUG
-
mitoxantrone
- DRUG
-
daunorubicin
- DRUG
Sponsors & Collaborators
-
Technische Universität Dresden
lead OTHER
Principal Investigators
-
Gerhard Ehninger, MD · Department of Medicine I, University Hospital Carl Gustav Carus Dresden
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- PREVENTION
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 16 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2000-01-31
- Primary Completion
- 2012-11-30
- Completion
- 2012-11-30
Countries
- Germany
Study Locations
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