Cytarabine (Ara-C) in Children With Acute Promyelocytic Leukemia (APL)
Conditions: official terms
Leukemia - Leukemia, Promyelocytic, Acute
Conditions: Keywords
ara-c, As2O3, pediatric, acute
Study Type
Study Phase
Study Design
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Name: Ara-c
Type: Drug
Overall Status
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
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 -
Start Date
May 2010
Completion Date
December 2018
Chinese Academy of Medical Sciences
Chinese Academy of Medical Sciences
Record processing date processed this data on July 28, 2015 page