Ignite Creation Date:
2024-05-05 @ 11:23 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00023777
Status:
COMPLETED
Last Update Posted:
2015-03-06
First Post:
2001-09-13
Brief Title:
S0112 Cytarabine and Daunorubicin in Treating Older Patients With Acute Myeloid Leukemia
Sponsor:
SWOG Cancer Research Network
Organization:
SWOG Cancer Research Network
Study Overview
Official Title:
A Phase II Study Of Daunomycin And ARA-C Both Given By Continous 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 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 combining cytarabine and daunorubicin in treating older patients who have acute myeloid leukemia that has not been previously treated
PURPOSE Phase II trial to study the effectiveness of combining cytarabine and daunorubicin in treating older patients who have acute myeloid leukemia that has not been previously treated
Detailed Description:
OBJECTIVES
Determine the efficacy of cytarabine and daunorubicin as induction chemotherapy in older patients with previously untreated non-M3 acute myeloid leukemia
Determine the frequency and severity of toxic effects of this regimen in these patients
OUTLINE This is a multicenter study
Patients receive induction chemotherapy comprising daunorubicin IV continuously over days 1-3 and cytarabine IV continuously over days 1-7 Patients may be treated with a second course of induction chemotherapy beginning on day 19 if remission is not achieved at that time Patients also receive filgrastim G-CSF or sargramostim GM-CSF IV or subcutaneously daily beginning on day 15 and continuing until blood counts recover
Patients who achieve remission after the first or second course of induction chemotherapy receive consolidation chemotherapy comprising daunorubicin IV continuously over days 1 and 2 and cytarabine IV continuously over days 1-5 Beginning no earlier than day 19 patients receive a second course of consolidation chemotherapy
Patients are followed every 3 months for 1 year every 6 months for 1 year and then annually for 3 years
PROJECTED ACCRUAL Approximately 30-55 patients will be accrued for this study within 8-9 months
Determine the efficacy of cytarabine and daunorubicin as induction chemotherapy in older patients with previously untreated non-M3 acute myeloid leukemia
Determine the frequency and severity of toxic effects of this regimen in these patients
OUTLINE This is a multicenter study
Patients receive induction chemotherapy comprising daunorubicin IV continuously over days 1-3 and cytarabine IV continuously over days 1-7 Patients may be treated with a second course of induction chemotherapy beginning on day 19 if remission is not achieved at that time Patients also receive filgrastim G-CSF or sargramostim GM-CSF IV or subcutaneously daily beginning on day 15 and continuing until blood counts recover
Patients who achieve remission after the first or second course of induction chemotherapy receive consolidation chemotherapy comprising daunorubicin IV continuously over days 1 and 2 and cytarabine IV continuously over days 1-5 Beginning no earlier than day 19 patients receive a second course of consolidation chemotherapy
Patients are followed every 3 months for 1 year every 6 months for 1 year and then annually for 3 years
PROJECTED ACCRUAL Approximately 30-55 patients will be accrued for this study within 8-9 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 |
|---|---|---|---|
| U10CA032102 | NIH | SWOG | httpsreporternihgovquickSearchU10CA032102 |
| S0112 | OTHER | None | None |