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

NCT01191541 | Completed Phase 4 Results DMC

• 1 other identifier: CCAPL2010
• Study Type: interventional
• Target: 65
• Locations: 1 country
• Sites: 2

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.

Conditions

Leukemia

Keywords

ara-c; As2O3; pediatric; acute

Outcome Measures

Primary Outcomes (2)

• the Overall Survival of APL Patients Treated With Retinoic Acid Receptor Alpha (ATRA) and Arsenic Trioxide (ATO) Based Trial

  We assessed the OS of APL patients when ATRA and ATO were used. The overall survival (OS) durations was calculated from the date of diagnosis to last follow-up or death.

  two years

• the Event-free Survival (EFS） of APL Patients Treated With Retinoic Acid Receptor Alpha (ATRA) and Arsenic Trioxide (ATO) Based Trial

  We assessed the EFS of APL patients treated with retinoic acid receptor alpha (ATRA) and Arsenic Trioxide (ATO) based trial. Event-free survival (EFS) was defined as time from diagnosis to last follow-up or an event (relapse or death).

  2 years

Secondary Outcomes (1)

• Number of Participants With Side Effects

  three years

Study Arms (2)

DNR+Ara-c(Ara-C group)

ACTIVE COMPARATOR

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

Drug: DNR:; Drug: Ara-c

DNR(No Ara-C group)

EXPERIMENTAL

patients in this group were treated with DNR alone in consolidation

Drug: DNR:

Interventions

Ara-c DRUG

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

DNR+Ara-c(Ara-C group)

DNR: DRUG

DNR：45mg/m2 d1-3

DNR(No Ara-C group); DNR+Ara-c(Ara-C group)

Eligibility Criteria

• Age: 1 Year - 14 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Acute Promyelocytic Leukemia (APL)

You may not qualify if:

• \> 14

Sponsors & Collaborators

• Xiaofan Zhu: lead

Study Sites (2)

Institute of Hematology & Blood Diseases Hospital

Tianjin, Tianjin Municipality, 300020, China

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, 300020, China

Location

Related Publications (2)

• 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.

  PMID: 16234524 BACKGROUND

• 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.

  PMID: 29615003 DERIVED

MeSH Terms

Conditions

Leukemia

Interventions

Cytarabine

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Arabinonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Results Point of Contact

• Title: xiaofan Zhu
• Organization: Department of pediatrics, Institute of Hematology and Blood Diseases Hospital.

xfzhu@ihcams.ac.cn

+86 22 23909001

Study Officials

• Xiaofan Zhu, MD

  Department of Pediatrics, CAMS&PUMC

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: UNKNOWN
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: chief physician

Study Record Dates

• First Submitted: August 18, 2010
• First Posted: August 31, 2010
• Study Start: May 1, 2010
• Primary Completion: February 1, 2017
• Study Completion: February 1, 2017
• Last Updated: August 10, 2021
• Results First Posted: February 21, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)