Phase 4
N=65
Cytarabine (Ara-C) in Children With Acute Promyelocytic Leukemia (APL)
Leukemia
Bottom Line
View on ClinicalTrials.gov: NCT01191541 ↗Enrolled (actual)
65
Serious AEs
3.3%
Results posted
Feb 2021
Primary outcome: Primary: the Overall Survival of APL Patients Treated With Retinoic Acid Receptor Alpha (ATRA) and Arsenic Trioxide (ATO) Based Trial — 1; 0; 0; 0 participants — p=<0.05
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- DNR: (Drug); Ara-c (Drug)
- Age
- Pediatric · 1+ yrs
- Sex
- All
- Sponsor
- Xiaofan Zhu
- Primary completion
- Feb 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY the Overall Survival of APL Patients Treated With Retinoic Acid Receptor Alpha (ATRA) and Arsenic Trioxide (ATO) Based Trial |
1; 0; 0; 0 | <0.05 sig |
| PRIMARY the Event-free Survival (EFS） of APL Patients Treated With Retinoic Acid Receptor Alpha (ATRA) and Arsenic Trioxide (ATO) Based Trial |
0; 1; 0; 0 | — |
| SECONDARY Number of Participants With Side Effects |
5; 1; 26; 0; 7; 7 | — |
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.
Eligibility Criteria
Inclusion Criteria
- Acute Promyelocytic Leukemia (APL)
Exclusion Criteria
- > 14
Data sourced from ClinicalTrials.gov (NCT01191541). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.