CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 205 enrolled
Drug / intervention
asparaginase +5 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/NCT00369317
NCT00369317Phase 3Completed
CompareCT.gov

The Treatment of Down Syndrome Children With Acute Myeloid Leukemia (AML) and Myelodysplastic Syndromes (MDS) Under the Age of 4 Years

Children's Oncology Group·interventional·Posted Aug 29, 2006·Updated Jan 28, 2022

In Brief

A Phase 3 clinical trial evaluating asparaginase, daunorubicin hydrochloride, and 4 other interventions for Childhood Acute Basophilic Leukemia and 14 related conditions. Completed, enrolled 205 participants across 97 sites in 4 countries.

Detailed Summary

This phase III trial is studying how well combination chemotherapy works in treating young patients with Down syndrome and acute myeloid leukemia or myelodysplastic syndromes. 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 Basophilic Leukemia, Childhood Acute Eosinophilic Leukemia, Childhood Acute Erythroleukemia (M6), Childhood Acute Megakaryocytic Leukemia (M7), Childhood Acute Minimally Differentiated Myeloid Leukemia (M0), Childhood Acute Monoblastic Leukemia (M5a), Childhood Acute Monocytic Leukemia (M5b), Childhood Acute Myeloblastic Leukemia With Maturation (M2), Childhood Acute Myeloblastic Leukemia Without Maturation (M1), Childhood Acute Myelomonocytic Leukemia (M4), Childhood Myelodysplastic Syndromes, de Novo Myelodysplastic Syndromes, Secondary Acute Myeloid Leukemia, Secondary Myelodysplastic Syndromes, Untreated Childhood Acute Myeloid Leukemia and Other Myeloid Malignancies
CountriesAustralia, Canada, Puerto Rico, United States
CollaboratorsNational Cancer Institute (NCI)

Timeline

Phase 3CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedAug 29, 2006
Enrollment StartMar 1, 2007
Primary CompletionDec 1, 2013
Study CompletionDec 31, 2021
TodayJul 2, 2026
Enrollment to primary: 6.8 yearsPosted 19.8 years ago

Interventions

asparaginasedrug

Given IM

daunorubicin hydrochloridedrug

Given IV

cytarabinedrug

Given IV or IT

thioguaninedrug

Given orally

etoposidedrug

Given IV

laboratory biomarker analysisother

Correlative studies