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


Phase 4
16 Years
N/A
Open (Enrolling)
Both
Leukemia, Promyelocytic, Acute

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Trial Information

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


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.


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

overall survival

Principal Investigator

Gerhard Ehninger, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Department of Medicine I, University Hospital Carl Gustav Carus Dresden

Authority:

Germany: Federal Institute for Drugs and Medical Devices

Study ID:

MK1-192

NCT ID:

NCT00180128

Start Date:

January 2000

Completion Date:

November 2012

Related Keywords:

  • Leukemia, Promyelocytic, Acute
  • acute promyelocytic leukemia
  • risk adapted therapy
  • Leukemia
  • Leukemia, Promyelocytic, Acute

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