Clinical trial · Interventional
Cytarabine (Ara-C) in Children With Acute Promyelocytic Leukemia (APL)
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.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Leukemia | Leukemia | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Ara-c | Drug | Cytarabine | ALIAS |
| DNR: | Drug | Daunorubicin | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- DNR+Ara-c(Ara-C group)
- description
- patients in this group were treated with DNR+Ara-C in consolidation
- interventionNames
- Drug: DNR:
- Drug: Ara-c
- type
- EXPERIMENTAL
- label
- DNR(No Ara-C group)
- description
- patients in this group were treated with DNR alone in consolidation
- interventionNames
- Drug: DNR:
Primary outcomes (2)
- measure
- the Overall Survival of APL Patients Treated With Retinoic Acid Receptor Alpha (ATRA) and Arsenic Trioxide (ATO) Based Trial
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 1 Year
- Maximum age
- 14 Years
Show eligibility criteria text
Inclusion Criteria: * Acute Promyelocytic Leukemia (APL) Exclusion Criteria: * \> 14
References
Publications (2)
- BACKGROUNDOrtega 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. PMID 16234524
- DERIVEDZhang 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. PMID 29615003