Overview

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

Status:
Completed

Trial end date:
2017-02-01

Target enrollment:
0

Participant gender:
All

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.

Phase:

Phase 4

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Chinese Academy of Medical Sciences
Xiaofan Zhu

Treatments:

Arsenic trioxide
Cytarabine

Criteria

Inclusion Criteria:

- Acute Promyelocytic Leukemia (APL)

Exclusion Criteria:

- > 14