NCT01191541

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

Treatment of Newly Diagnosed Patients With Acute Promyelocytic Leukemia in Children: Remission Induction With All-transretinoic Acid (ATRA) and Arsenic Trioxide (As2O3). Consolidation With Daunorubicin(DNR)+Ara-c or DNR Alone.

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 65 (actual)
• Sponsor: Xiaofan Zhu · Unknown
• Sex: All
• Age: 1 Year – 14 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Some studies suggest patients with high-risk disease should be treated with intensified doses of anthracycline, or intermediate/ high-dose Ara-C or As2O3 as an early consolidation, so as to decrease the risk of relapse.However, a higher cumulative dose of anthracycline may lead to cardiac toxicity, especially for children. In addition, containing Ara-C will led to more therapy-related toxicity. The benefit to add Ara-C to the schedules is questionable and remains a matter of investigation in children.

Conditions

• Leukemia

Interventions

Type	Name	Description
DRUG	DNR:	DNR：45mg/m2 d1-3
DRUG	Ara-c	DNR+ARA-C：DNR：45mg/m2 d1-3;Ara-C :1g/m2 d1-3

Timeline

• Start date: 2010-05-01
• Primary completion: 2017-02-01
• Completion: 2017-02-01
• First posted: 2010-08-31
• Last updated: 2021-08-10
• Results posted: 2021-02-21

Locations

2 sites across 1 country: China