Cytarabine (Ara-C) in Children With Acute Promyelocytic Leukemia (APL)
Conditions
Leukemia
Conditions: official terms
Leukemia - Leukemia, Promyelocytic, Acute
Conditions: Keywords
ara-c, As2O3, pediatric, acute
Study Type
Interventional
Study Phase
N/A
Study Design
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: Ara-c
Type: Drug
Overall Status
Recruiting
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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: 16 Years
Minimum Age: 1 Year
Gender: Both
Criteria: Inclusion Criteria:

- Acute Promyelocytic Leukemia (APL)

Exclusion Criteria:

- > 16
Location
Department of Pediatrics, Institute of Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Tianjin, PR China
Tianjin, China
Status: Recruiting
Contact: Xiaofan Zhu, MD - +86 22 23909001 - zhuxiaof@yahoo.com.cn
Start Date
May 2010
Completion Date
December 2018
Sponsors
Chinese Academy of Medical Sciences
Source
Chinese Academy of Medical Sciences
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page