CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 65 enrolled
Drug / intervention
DNR: +1 moredrug
Likely dose
DNR: 45mg/m2from record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01191541
NCT01191541Phase 4Completed

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.

Xiaofan Zhu·interventional·Posted Aug 31, 2010·Updated Aug 10, 2021

In Brief

A Phase 4 clinical trial evaluating DNR: and Ara-c for Leukemia. Completed, enrolled 65 participants across 2 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsLeukemia
CountriesChina
Collaborators--

Timeline

Phase 4CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedAug 31, 2010
Enrollment StartMay 1, 2010
Primary CompletionFeb 1, 2017
TodayJul 2, 2026
Enrollment to primary: 6.8 yearsPosted 15.8 years ago

Interventions

DNR:drug

DNR:45mg/m2 d1-3

Ara-cdrug

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