CI

At a glance

ClinicalIndex Comparison Record
Phase 3Active· 280 enrolled
Drug / intervention
Asparaginase +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/NCT02521493
NCT02521493Phase 3Active

Risk-Stratified Therapy for Acute Myeloid Leukemia in Down Syndrome

Children's Oncology Group·interventional·Posted Aug 13, 2015·Updated Aug 1, 2025

In Brief

A Phase 3 clinical trial evaluating Asparaginase, Asparaginase Erwinia chrysanthemi, and 6 other interventions for Acute Myeloid Leukemia and 4 related conditions. Active but no longer recruiting, targeting 280 participants across 191 sites in 6 countries.

Detailed Summary

This phase III trial studies response-based chemotherapy in treating newly diagnosed acute myeloid leukemia or myelodysplastic syndrome in younger patients with Down syndrome. Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Response-based chemotherapy separates patients into different risk groups and treats them according to how they respond to the first course of treatment (Induction I). Response-based treatment may be effective in treating acute myeloid leukemia or myelodysplastic syndrome in younger patients with Down syndrome while reducing the side effects.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesAustralia, Canada, New Zealand, Puerto Rico, Saudi Arabia, United States

Timeline

Phase 3ActiveOverdue
20162017201820192020202120222023202420252026
First PostedAug 13, 2015
Enrollment StartDec 23, 2015
Primary CompletionJun 30, 2024
Study CompletionJun 30, 2026
TodayJul 2, 2026
Enrollment to primary: 8.5 yearsPosted 10.9 years ago

Interventions

Asparaginasedrug

Given IM or IV

Asparaginase Erwinia chrysanthemidrug

Given IM or IV

Cytarabinedrug

Given IT and IV

Daunorubicin Hydrochloridedrug

Given IV

Etoposidedrug

Given IV

Laboratory Biomarker Analysisother

Correlative studies

Mitoxantrone Hydrochloridedrug

Given IV

Thioguaninedrug

Given PO