Clinical Trial: AIDA2000 - Risk-Adapted Therapy for Patients With Acute Promyelocytic Leukemia

Study Status: Active, not recruiting
Recruit Status: Unknown status
Study Type: Interventional

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

Brief 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 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.
Sponsor: Technische Universität Dresden

Current Primary Outcome: overall survival

Original Primary Outcome:

  • - overall survival
  • - relapse-free survival
  • - complete remission rate


Current Secondary Outcome:

  • toxicity of the regimen
  • evaluation of additional risk factors
  • effectiveness of MRD as guidance for therapy decisions
  • relapse free survival
  • complete remission rate


Original Secondary Outcome:

  • - toxicity of the regimen
  • - feasibility of a risk-adapted therapy
  • - evaluation of additional risk factors
  • - effectiveness of MRD as guidance for therapy decisions


Information By: Technische Universität Dresden

Dates:
Date Received: September 12, 2005
Date Started: January 2000
Date Completion: November 2012
Last Updated: July 8, 2011
Last Verified: July 2011