drugset / Trial / NCT01191541

Cytarabine (Ara-C) in Children With Acute Promyelocytic Leukemia (APL)

NCT01191541

Phase 4 Completed 65 enrolled Xiaofan Zhu
RandomizedParallel-groupOpen-labelTreatment

Summary

Several groups, especially the PETHEMA group (in their LPA96 and 99 trials), obtained low relapse rates in newly diagnosed Acute Promyelocytic Leukemia (APL) patients by combining ll-transretinoic acid (ATRA) and anthracyclines without Ara-C, suggesting that avoiding Ara-C in the chemotherapy of APL reduced treatment toxicity without increasing relapses. While the relapse rate for the children with white blood cell(WBC) counts greater than 10×109/L at presentation were higher than those WBC counts less than 10×109/L (31% and 3.5%,respectively) in the LPA96 and 99 trials. A recent adult randomized trial show that avoiding Ara-C leads to an increased risk of relapse in the APL patients with WBC counts less than 10×109/L. The role of the Ara-C remains controversial. And there are very limited data reported on children with APL so far.

Timeline

Start
2010-05
Primary completion
2017-02
Completion
2017-02

Drugs

EvaluationDrugModalityDoseRoute
Comparator Cytarabine Small molecule 1 g/kg
Background Daunorubicin Small molecule 45 mg/m2

Indications