Phase 4
Completed N=65
Cytarabine (Ara-C) in Children With Acute Promyelocytic Leukemia (APL)
Source: ClinicalTrials.gov NCT01191541 ↗Enrolled (actual)
65
Serious AEs
3.3%
Results posted
Feb 2021
Primary outcomePrimary: 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
◆ Published Evidence
Established
22citations · ~3 / year
Role of cytarabine in paediatric acute promyelocytic leukemia treated with the combination of all-trans retinoic acid and arsenic trioxide: a randomized controlled trial.
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.
Linked Publications
-
Role of cytarabine in paediatric acute promyelocytic leukemia treated with the combination of all-trans retinoic acid and arsenic trioxide: a randomized controlled trial.
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 | — |
Eligibility Criteria
Inclusion Criteria
- Acute Promyelocytic Leukemia (APL)
Exclusion Criteria
- > 14
Data sourced from ClinicalTrials.gov (NCT01191541) and the linked publication. 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. Informational only — not medical advice.