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