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

Primary Purpose

Leukemia

Status
Completed
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
DNR:
Ara-c
Sponsored by
Xiaofan Zhu
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Leukemia focused on measuring ara-c, As2O3, pediatric, acute

Eligibility Criteria

1 Year - 14 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Acute Promyelocytic Leukemia (APL)

Exclusion Criteria:

  • > 14

Sites / Locations

  • Institute of Hematology & Blood Diseases Hospital
  • Department of Pediatrics, Institute of Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Tianjin, PR China

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

DNR+Ara-c(Ara-C group)

DNR(No Ara-C group)

Arm Description

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

patients in this group were treated with DNR alone in consolidation

Outcomes

Primary Outcome Measures

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.
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).

Secondary Outcome Measures

Number of Participants With Side Effects
Also, we compared the side effect and outcome between the two groups.To assessed whether Ara-C could be omitted when ATO and ATRA were used.

Full Information

First Posted
August 18, 2010
Last Updated
August 8, 2021
Sponsor
Xiaofan Zhu
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1. Study Identification

Unique Protocol Identification Number
NCT01191541
Brief Title
Cytarabine (Ara-C) in Children With Acute Promyelocytic Leukemia (APL)
Acronym
Ara-C
Official Title
Treatment of Newly Diagnosed Patients With Acute Promyelocytic Leukemia in Children: Remission Induction With All-transretinoic Acid (ATRA) and Arsenic Trioxide (As2O3). Consolidation With Daunorubicin(DNR)+Ara-c or DNR Alone.
Study Type
Interventional

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Completed
Study Start Date
May 2010 (Actual)
Primary Completion Date
February 2017 (Actual)
Study Completion Date
February 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Xiaofan Zhu

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Leukemia
Keywords
ara-c, As2O3, pediatric, acute

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
65 (Actual)

8. Arms, Groups, and Interventions

Arm Title
DNR+Ara-c(Ara-C group)
Arm Type
Active Comparator
Arm Description
patients in this group were treated with DNR+Ara-C in consolidation
Arm Title
DNR(No Ara-C group)
Arm Type
Experimental
Arm Description
patients in this group were treated with DNR alone in consolidation
Intervention Type
Drug
Intervention Name(s)
DNR:
Intervention Description
DNR:45mg/m2 d1-3
Intervention Type
Drug
Intervention Name(s)
Ara-c
Intervention Description
DNR+ARA-C:DNR:45mg/m2 d1-3;Ara-C :1g/m2 d1-3
Primary Outcome Measure Information:
Title
the Overall Survival of APL Patients Treated With Retinoic Acid Receptor Alpha (ATRA) and Arsenic Trioxide (ATO) Based Trial
Description
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.
Time Frame
two years
Title
the Event-free Survival (EFS) of APL Patients Treated With Retinoic Acid Receptor Alpha (ATRA) and Arsenic Trioxide (ATO) Based Trial
Description
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).
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Number of Participants With Side Effects
Description
Also, we compared the side effect and outcome between the two groups.To assessed whether Ara-C could be omitted when ATO and ATRA were used.
Time Frame
three years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Year
Maximum Age & Unit of Time
14 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Acute Promyelocytic Leukemia (APL) Exclusion Criteria: > 14
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xiaofan Zhu, MD
Organizational Affiliation
Department of Pediatrics, CAMS&PUMC
Official's Role
Principal Investigator
Facility Information:
Facility Name
Institute of Hematology & Blood Diseases Hospital
City
Tianjin
State/Province
Tianjin
ZIP/Postal Code
300020
Country
China
Facility Name
Department of Pediatrics, Institute of Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Tianjin, PR China
City
Tianjin
ZIP/Postal Code
300020
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
16234524
Citation
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.
Results Reference
background
PubMed Identifier
29615003
Citation
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.
Results Reference
derived

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

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