Ignite Creation Date:
2024-05-05 @ 5:14 PM
Last Modification Date:
2024-10-26 @ 9:29 AM
Study NCT ID:
NCT00411281
Status:
WITHDRAWN
Last Update Posted:
2015-09-30
First Post:
2006-12-11
Brief Title:
Low-Dose Cytarabine in Treating Infants With Down Syndrome and Transient Myeloproliferative Disorder
Sponsor:
Childrens Oncology Group
Organization:
Childrens Oncology Group
Study Overview
Official Title:
Treatment of Transient Myeloproliferative Disorder TMD in Children With Down Syndrome DS
Status:
WITHDRAWN
Status Verified Date:
2013-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Per Group Chair This study will not move forward
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
RATIONALE Drugs used in chemotherapy such as cytarabine work in different ways to stop the growth of abnormal cells either by killing the cells or by stopping them from dividing Giving low-doses of cytarabine may be an effective treatment for Down syndrome and transient myeloproliferative disorder Sometimes the disease may not need treatment until it progresses In this case observation may be sufficient
PURPOSE This phase III trial is studying low-dose cytarabine to see how well it works in treating infants with Down syndrome and transient myeloproliferative disorder
PURPOSE This phase III trial is studying low-dose cytarabine to see how well it works in treating infants with Down syndrome and transient myeloproliferative disorder
Detailed Description:
OBJECTIVES
Primary
Determine whether very low-dose cytarabine can improve event-free survival EFS rates in infants with high-risk transient myeloproliferative disorder TMD using high-risk TMD patients from clinical trial COG-A2971 for historic comparison and in infants with intermediate-risk TMD using intermediate-risk TMD patients from clinical trial COG-A2971 for historic comparison
Maintain the current high overall EFS rate in low-risk TMD patients
Secondary
Assess the toxicity of this regimen in these patients
OUTLINE This is a nonrandomized multicenter crossover study Patients are stratified according to disease risk high or intermediate vs low
Group I patients with high- or intermediate-risk transient myeloproliferative disorder TMD Patients receive very low-dose cytarabine subcutaneously twice daily on days 1-7 Treatment repeats every 14 days for up to 4 courses in the absence of disease progression or unacceptable toxicity Patients achieving stable disease or complete or hepatic clinical remission undergo observation
Group II patients with low-risk TMD Patients are observed If symptoms of intermediate- or high-risk disease develop patients may crossover to group I
After completion of study treatment patients are followed periodically for 10 years
PROJECTED ACCRUAL A total of 180 patients will be accrued for this study
Primary
Determine whether very low-dose cytarabine can improve event-free survival EFS rates in infants with high-risk transient myeloproliferative disorder TMD using high-risk TMD patients from clinical trial COG-A2971 for historic comparison and in infants with intermediate-risk TMD using intermediate-risk TMD patients from clinical trial COG-A2971 for historic comparison
Maintain the current high overall EFS rate in low-risk TMD patients
Secondary
Assess the toxicity of this regimen in these patients
OUTLINE This is a nonrandomized multicenter crossover study Patients are stratified according to disease risk high or intermediate vs low
Group I patients with high- or intermediate-risk transient myeloproliferative disorder TMD Patients receive very low-dose cytarabine subcutaneously twice daily on days 1-7 Treatment repeats every 14 days for up to 4 courses in the absence of disease progression or unacceptable toxicity Patients achieving stable disease or complete or hepatic clinical remission undergo observation
Group II patients with low-risk TMD Patients are observed If symptoms of intermediate- or high-risk disease develop patients may crossover to group I
After completion of study treatment patients are followed periodically for 10 years
PROJECTED ACCRUAL A total of 180 patients will be accrued for this study
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| CDR0000518352 | OTHER | Clinical Trialsgov | None |
| COG-AAML0532 | OTHER | None | None |