CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 106 enrolled
Drug / intervention
Arsenic Trioxide +7 moredrug
Likely dose
Not stated in 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/NCT00866918
NCT00866918Phase 3Completed
CompareCT.gov

Risk Adapted Treatment of Newly Diagnosed Childhood Acute Promyelocytic Leukemia (APL) Using Arsenic Trioxide (Trisenox® ) During Consolidation

Children's Oncology Group·interventional·Posted Mar 23, 2009·Updated Oct 25, 2022

In Brief

A Phase 3 clinical trial evaluating Arsenic Trioxide, Cytarabine, and 6 other interventions for Childhood Acute Promyelocytic Leukemia With PML-RARA and Myeloid Neoplasm. Completed, enrolled 106 participants across 121 sites in 3 countries.

Detailed Summary

This phase III trial is studying combination chemotherapy to see how well it works in treating young patients with newly diagnosed acute promyelocytic leukemia. Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more cancer cells.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsChildhood Acute Promyelocytic Leukemia With PML-RARA, Myeloid Neoplasm
CountriesCanada, Puerto Rico, United States
CollaboratorsNational Cancer Institute (NCI)

Timeline

Phase 3CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedMar 23, 2009
Enrollment StartMar 9, 2009
Primary CompletionJun 30, 2015
Study CompletionSep 30, 2022
TodayJul 2, 2026
Enrollment to primary: 6.3 yearsPosted 17.3 years ago

Interventions

Arsenic Trioxidedrug

Given IV

Cytarabinedrug

Given IT or IV

Diagnostic Laboratory Biomarker Analysisother

Correlative studies

Idarubicindrug

Given IV

Mercaptopurinedrug

Given orally

Methotrexatedrug

Given orally

Mitoxantrone Hydrochloridedrug

Given IV

Tretinoindrug

Given orally