Ignite Creation Date:
2024-05-05 @ 11:30 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00066794
Status:
COMPLETED
Last Update Posted:
2015-03-06
First Post:
2003-08-06
Brief Title:
S0301 Cyclosporine Daunorubicin and Cytarabine in Treating Older Patients With Previously Untreated Acute Myeloid Leukemia
Sponsor:
SWOG Cancer Research Network
Organization:
SWOG Cancer Research Network
Study Overview
Official Title:
A Phase II Study Of Induction With Daunorubicin Cytarabine And Cyclosporine All By Continuous IV Infusion For Previously Untreated Non-M3 Acute Myeloid Leukemia AML In Patients Of Age 56 Or Older
Status:
COMPLETED
Status Verified Date:
2015-03
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 such as cyclosporine daunorubicin and cytarabine 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 This phase II trial is studying how well giving cyclosporine together with daunorubicin and cytarabine works in treating older patients with untreated acute myeloid leukemia
PURPOSE This phase II trial is studying how well giving cyclosporine together with daunorubicin and cytarabine works in treating older patients with untreated acute myeloid leukemia
Detailed Description:
OBJECTIVES
Determine the safety and efficacy of cyclosporine daunorubicin and cytarabine in older patients with previously untreated acute myeloid leukemia
Determine the frequency and severity of toxic effects of this regimen in these patients
Determine preliminarily the frequency and prognostic significance of functional and phenotypic P-glycoprotein expression and cytogenetics in patients treated with this regimen
Determine preliminarily the pharmacokinetic characteristics of this regimen in these patients
OUTLINE This is a multicenter study
Induction therapy Patients receive cyclosporine IV and daunorubicin IV continuously on days 1-3 and cytarabine IV continuously on days 1-7 Patients who achieve complete response CR after chemotherapy receive filgrastim G-CSF or sargramostim GM-CSF IV or subcutaneously beginning on day 15 or 20 and continuing until blood counts recover Patients who maintain CR after 2 courses of induction therapy proceed to consolidation therapy
Consolidation therapy Patients receive treatment as in induction therapy with cyclosporine and daunorubicin on days 1-2 and cytarabine on days 1-5 Patients achieving CR receive an additional course of chemotherapy beginning at least 14 days after completion of the first course of cytarabine
Patients are followed every 3 months for 1 year every 6 months for 1 year and then annually for 3 years
PROJECTED ACCRUAL A total of 25-64 patients will be accrued for this study within 13 months
Determine the safety and efficacy of cyclosporine daunorubicin and cytarabine in older patients with previously untreated acute myeloid leukemia
Determine the frequency and severity of toxic effects of this regimen in these patients
Determine preliminarily the frequency and prognostic significance of functional and phenotypic P-glycoprotein expression and cytogenetics in patients treated with this regimen
Determine preliminarily the pharmacokinetic characteristics of this regimen in these patients
OUTLINE This is a multicenter study
Induction therapy Patients receive cyclosporine IV and daunorubicin IV continuously on days 1-3 and cytarabine IV continuously on days 1-7 Patients who achieve complete response CR after chemotherapy receive filgrastim G-CSF or sargramostim GM-CSF IV or subcutaneously beginning on day 15 or 20 and continuing until blood counts recover Patients who maintain CR after 2 courses of induction therapy proceed to consolidation therapy
Consolidation therapy Patients receive treatment as in induction therapy with cyclosporine and daunorubicin on days 1-2 and cytarabine on days 1-5 Patients achieving CR receive an additional course of chemotherapy beginning at least 14 days after completion of the first course of cytarabine
Patients are followed every 3 months for 1 year every 6 months for 1 year and then annually for 3 years
PROJECTED ACCRUAL A total of 25-64 patients will be accrued for this study within 13 months
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 |
|---|---|---|---|
| S0301 | OTHER | None | None |
| U10CA032102 | NIH | SWOG | httpsreporternihgovquickSearchU10CA032102 |