Clinical Trial: AIDA 2000 Guidelines

Study Status: Completed
Recruit Status: Unknown status
Study Type: Interventional

Official Title: Guidelines for Treatment of Acute Promyelocytic Leukemia

Brief Summary: Prospective use of RT-PCR for PML/RARa might be used to guide a total tehrapy approach in APL, including refined diagnosis, front-line treatment, assessment of response and anticipated salvage therapy for patients who undergo molecular relapse.

Detailed Summary:
Sponsor: Gruppo Italiano Malattie EMatologiche dell'Adulto

Current Primary Outcome: Treatment-related toxicity event rate during the ATRA-including consolidation treatment [ Time Frame: At the end of the study ]

Original Primary Outcome: Treatment-related toxicity event rate during the ATRA-including consolidation treatment

Current Secondary Outcome:

  • Event Free Survival, Molecular and Hematological Disease-Free and Overall Survival in each risk group [ Time Frame: At the end of the study ]
  • The rates of molecular remission, after consolidation, in each risk group [ Time Frame: At the end of the study ]
  • Induction morbidity and mortality after the inclusion of the prophylactic measures for the ATRA Syndrome and hemorrhagic complications [ Time Frame: At the end of the study ]
  • The overall toxicity of induction, consolidation, and maintenance chemotherapy in each risk group [ Time Frame: At the end of the study ]
  • The impact on survival of a "total" treatment approach for APL including molecular evaluation of minimal residual disease and salvage tehrapy administration at the time of molecular or hematological relapse [ Time Frame: At the end of the study ]


Original Secondary Outcome:

  • Event Free Survival, Molecular and Hematological Disease-Free and Overall Survival in each risk group
  • The rates of molecular remission, after consolidation, in each risk group
  • Induction morbidity and mortality after the inclusion of the prophylactic measures for the ATRA Syndrome and hemorrhagic complications
  • The overall toxicity of induction, consolidation, and maintenance chemotherapy in each risk group
  • The impact on survival of a "total" treatment approach for APL including molecular evaluation of minimal residual disease and salvage tehrapy administration at the time of molecular or hematological relapse


Information By: Gruppo Italiano Malattie EMatologiche dell'Adulto

Dates:
Date Received: February 5, 2010
Date Started: May 2000
Date Completion:
Last Updated: November 24, 2010
Last Verified: November 2010