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

Xiaofan Zhu

Status and phase: Completed; Phase 4

Conditions: Leukemia

Treatments: Drug: DNR:; Drug: Ara-c

Study type: Interventional

Funder types: Other

Identifiers

NCT01191541

CCAPL2010

Details and patient eligibility

About

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.

Full 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.

Enrollment: 65 patients

Sex: All

Ages: 1 to 14 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Acute Promyelocytic Leukemia (APL)

Exclusion criteria

• > 14

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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65 participants in 2 patient groups

DNR+Ara-c(Ara-C group)

Active Comparator group

Description:

patients in this group were treated with DNR+Ara-C in consolidation

Treatment:

Drug: DNR:

Drug: Ara-c

DNR(No Ara-C group)

Experimental group

Description:

patients in this group were treated with DNR alone in consolidation

Treatment:

Drug: DNR: