Treatment of Newly Diagnosed Patients With Acute Promyelocytic Leukemia (PETHEMA LPA 2005)
Status:
Completed
Trial end date:
2013-12-01
Target enrollment:
Participant gender:
Summary
Primary objectives
- To evaluate the efficacy and toxicity of a risk-adapted protocol that use idarubicin for
induction and consolidation therapy in patients with APL.
- To evaluate the impact of mitoxantrone reduction on the event-free, disease-free, and
overall survival, as well as on the duration of remission and cumulative incidence of
relapse in low- and intermediate-risk patients with APL.
- To evaluate the impact of the addition of ara-C to idarubicin courses of consolidation
for high-risk patients (administered as in the original GIMEMA protocols) on the
event-free, disease-free, and overall survival, as well as on the duration of remission
and cumulative incidence of relapse.
- To evaluate the toxicity of the induction, consolidation, and maintenance chemotherapy
in the whole series and in each treatment group in patients with APL.
Secondary objectives
• To compare all outcomes with those achieved with the PETHEMA LPA99 protocol.