A Randomized Trial Assessing the Roles of AraC in Newly Diagnosed APL Promyelocytic Leukemia (APL)
Status:
Completed
Trial end date:
2004-06-01
Target enrollment:
Participant gender:
Summary
The first purpose of this randomized trial will be to compare the best treatment group of APL
93 trial (ATRA with early introduction of anthracycline-AraC chemotherapy, followed by 2
consolidation anthracycline-AraC courses and maintenance combining continuous chemotherapy
and intermittent ATRA) to the same regimen, but without AraC. It is hoped that the
investigational arm, with anthracycline alone chemotherapy (without AraC), will have reduced
toxicity without increasing the incidence of relapse, by comparison with a classical
induction/consolidation anthracycline-AraC regimen
Thus :
the main end point for this first randomization is relapse at 2 years secondary end points
are : complete remission rate ; survival and event free survival at 2 years, and
quality-adjusted survival (Q-TWiST).
2) Because patients with initial WBC counts > 10000/mm3 (ie very high counts for APL) appear
to remain at relatively high risk of relapse even with the current reference treatment, they
will not be included in this trial that assesses the reduction of chemotherapy. On the
contrary: i) they will all receive the standard chemotherapy (best treatment group of APL 93
trial);
Thus :
the main end point for this second randomization is relapse at 2 years secondary end points
are : survival and event free survival at 2 years 3)Elderly patients with initial WBC ≤
10000/m3 will receive consolidation chemotherapy without AraC during the first chemotherapy
course, and reduced doses of AraC during the second and third course, followed by G-CSF.
Phase:
Phase 3
Details
Lead Sponsor:
Groupe d'etude et de travail sur les leucemies aigues promyelocytaires