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

NCT ID: NCT01191541

Last Updated: 2021-08-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 65 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-05-31
• Study Completion Date: 2017-02-28

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

DNR+Ara-c(Ara-C group)

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

Group Type: ACTIVE_COMPARATOR

DNR:

Intervention Type: DRUG

DNR：45mg/m2 d1-3

Ara-c

Intervention Type: DRUG

DNR+ARA-C：DNR：45mg/m2 d1-3;Ara-C :1g/m2 d1-3

DNR(No Ara-C group)

patients in this group were treated with DNR alone in consolidation

Group Type: EXPERIMENTAL

DNR:

Intervention Type: DRUG

DNR：45mg/m2 d1-3

Interventions

DNR:

DNR：45mg/m2 d1-3

Intervention Type: DRUG

Ara-c

DNR+ARA-C：DNR：45mg/m2 d1-3;Ara-C :1g/m2 d1-3

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Acute Promyelocytic Leukemia (APL)

Exclusion Criteria

• > 14

• Minimum Eligible Age: 1 Year
• Maximum Eligible Age: 14 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Xiaofan Zhu

UNKNOWN

Sponsor Role: lead

Responsible Party

Xiaofan Zhu

chief physician

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Xiaofan Zhu, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Pediatrics, CAMS&PUMC

Locations

Institute of Hematology & Blood Diseases Hospital

Tianjin, Tianjin Municipality, China

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

Countries

China

References

Ortega JJ, Madero L, Martin G, Verdeguer A, Garcia P, Parody R, Fuster J, Molines A, Novo A, Deben G, Rodriguez A, Conde E, de la Serna J, Allegue MJ, Capote FJ, Gonzalez JD, Bolufer P, Gonzalez M, Sanz MA; PETHEMA Group. Treatment with all-trans retinoic acid and anthracycline monochemotherapy for children with acute promyelocytic leukemia: a multicenter study by the PETHEMA Group. J Clin Oncol. 2005 Oct 20;23(30):7632-40. doi: 10.1200/JCO.2005.01.3359.

Reference Type: BACKGROUND

PMID: 16234524 (View on PubMed)

Zhang L, Zou Y, Chen Y, Guo Y, Yang W, Chen X, Wang S, Liu X, Ruan M, Zhang J, Liu T, Liu F, Qi B, An W, Ren Y, Chang L, Zhu X. Role of cytarabine in paediatric acute promyelocytic leukemia treated with the combination of all-trans retinoic acid and arsenic trioxide: a randomized controlled trial. BMC Cancer. 2018 Apr 3;18(1):374. doi: 10.1186/s12885-018-4280-2.

Reference Type: DERIVED

PMID: 29615003 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

CCAPL2010

Identifier Type: -

Identifier Source: org_study_id