Ignite Creation Date:
2024-05-05 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003361
Status:
COMPLETED
Last Update Posted:
2013-06-26
First Post:
1999-11-01
Brief Title:
Decitabine in Treating Patients With Myelodysplastic Syndrome
Sponsor:
Memorial Sloan Kettering Cancer Center
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Phase II Study With Decitabine 5-aza-2-Deoxycytidine DAC in Myelodysplastic Syndromes
Status:
COMPLETED
Status Verified Date:
2009-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
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 use different ways to stop tumor cells from dividing so they stop growing or die
PURPOSE Phase II trial to study the effectiveness of decitabine in treating patients with myelodysplastic syndrome
PURPOSE Phase II trial to study the effectiveness of decitabine in treating patients with myelodysplastic syndrome
Detailed Description:
OBJECTIVES I Determine the response of patients with myelodysplastic syndromes including chronic myelomonocytic leukemia to decitabine
OUTLINE This is an open label multicenter study Patients are stratified by disease low risk myelodysplastic syndrome MDS vs high risk MDS vs chronic myelomonocytic leukemia Patients receive decitabine as a 4 hour infusion every 8 hours on days 1-3 Treatment continues every 6-8 weeks for 4-6 courses Patients are followed at 6 and 12 months
PROJECTED ACCRUAL Approximately 75 patients will be accrued for this study over 1 year
OUTLINE This is an open label multicenter study Patients are stratified by disease low risk myelodysplastic syndrome MDS vs high risk MDS vs chronic myelomonocytic leukemia Patients receive decitabine as a 4 hour infusion every 8 hours on days 1-3 Treatment continues every 6-8 weeks for 4-6 courses Patients are followed at 6 and 12 months
PROJECTED ACCRUAL Approximately 75 patients will be accrued for this study over 1 year
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 |
|---|---|---|---|
| CDR0000066343 | REGISTRY | None | None |
| NCI-G98-1444 | Registry Identifier | PDQ Physician Data Query | None |