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

Phase 4

Completed

• Conditions: Leukemia
• Interventions: Drug: Ara-c

• Registration Number: NCT01191541
• Lead Sponsor: Xiaofan Zhu

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2010-05
• Study First Submitted: 2010-08-18
• Study First Submitted QC: 2010-08-30
• Study First Posted: 2010-08-31
• Primary Completion: 2017-02
• Study Completion: 2017-02
• Results First Submitted: 2017-02-06
• Results First Submitted QC: 2021-02-03
• Results First Posted: 2021-02-21
• Status Verified: 2021-08
• Last Update Submitted: 2021-08-08
• Last Update Posted: 2021-08-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 65

Inclusion Criteria

• Acute Promyelocytic Leukemia (APL)

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Exclusion Criteria

• > 14

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
DNR+Ara-c(Ara-C group)	Ara-c	patients in this group were treated with DNR+Ara-C in consolidation

Primary Outcome Measures

Name	Time	Method
the Overall Survival of APL Patients Treated With Retinoic Acid Receptor Alpha (ATRA) and Arsenic Trioxide (ATO) Based Trial	two years	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	2 years	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

Name	Time	Method
Number of Participants With Side Effects	three years	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.

Trial Locations

Locations (2)

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

Institute of Hematology & Blood Diseases Hospital; 🇨🇳 Tianjin, Tianjin, China