Ignite Creation Date:
2024-05-05 @ 10:17 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00003758
Status:
UNKNOWN
Last Update Posted:
2009-02-09
First Post:
1999-11-01
Brief Title:
Combination Chemotherapy in Treating Patients With Relapsed Acute Myelogenous Leukemia
Sponsor:
European Organisation for Research and Treatment of Cancer - EORTC
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Treatment of Relapsed Acute Myelogenous Leukemia Consisting of Intermediate Dose Cytosine Arabinoside ARA-C Plus Interspaced Continuous Infusion Idarubicin Followed by Continuous Infusion of Low-Dose ARA-C A Phase II Study by the EORTC-LCG
Status:
UNKNOWN
Status Verified Date:
2001-01
Last Known Status:
ACTIVE_NOT_RECRUITING
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 cancer cells from dividing so they stop growing or die Combining more than one drug may kill more cancer cells
PURPOSE Phase II trial to study the effectiveness of combination chemotherapy consisting of cytarabine plus idarubicin in treating patients who have relapsed acute myelogenous leukemia
PURPOSE Phase II trial to study the effectiveness of combination chemotherapy consisting of cytarabine plus idarubicin in treating patients who have relapsed acute myelogenous leukemia
Detailed Description:
OBJECTIVES I Assess the feasibility and efficacy of intermediate dose cytarabine plus idarubicin followed by low dose cytarabine in patients with relapsed acute myelogenous leukemia
OUTLINE This is a multicenter study Patients receive intermediate dose cytarabine IV over 2 hours twice a day on days 1-5 idarubicin IV over 24 hours on days 1 3 and 5 and low dose cytarabine IV over 24 hours on days 6-15 If patients achieve complete remission by day 35 this regimen is repeated once If patients achieve partial remission by day 35 this regimen is repeated except with an additional day of idarubicin on day 7 If these patients then achieve complete remission by day 70 the regimen is repeated Patients may then undergo stem cell transplantation within 6 months of achieving complete remission Patients who have an HLA identical sibling available receive an allogeneic transplant others receive an autologous transplant Patients are followed monthly for 1 year every 3 months for 3 years then every 6 months thereafter
PROJECTED ACCRUAL A total of 24-60 patients will be accrued for this study
OUTLINE This is a multicenter study Patients receive intermediate dose cytarabine IV over 2 hours twice a day on days 1-5 idarubicin IV over 24 hours on days 1 3 and 5 and low dose cytarabine IV over 24 hours on days 6-15 If patients achieve complete remission by day 35 this regimen is repeated once If patients achieve partial remission by day 35 this regimen is repeated except with an additional day of idarubicin on day 7 If these patients then achieve complete remission by day 70 the regimen is repeated Patients may then undergo stem cell transplantation within 6 months of achieving complete remission Patients who have an HLA identical sibling available receive an allogeneic transplant others receive an autologous transplant Patients are followed monthly for 1 year every 3 months for 3 years then every 6 months thereafter
PROJECTED ACCRUAL A total of 24-60 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 |
|---|---|---|---|
| EORTC-06956 | None | None | None |