Ignite Creation Date:
2024-05-05 @ 4:35 PM
Last Modification Date:
2024-10-26 @ 9:22 AM
Study NCT ID:
NCT00274807
Status:
COMPLETED
Last Update Posted:
2011-02-11
First Post:
2006-01-10
Brief Title:
Combination Chemotherapy in Treating Patients With Newly Diagnosed Acute Myeloid Leukemia
Sponsor:
The Cleveland Clinic
Organization:
The Cleveland Clinic
Study Overview
Official Title:
Intensive Induction for Newly Diagnosed Acute Myelogenous Leukemia
Status:
COMPLETED
Status Verified Date:
2011-02
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 mitoxantrone cytarabine and etoposide work in different ways to stop the growth of cancer cells either by killing the cells or by stopping them from dividing Giving more than one drug combination chemotherapy may kill more cancer cells
PURPOSE This phase II trial is studying how well combination chemotherapy works in treating patients with newly diagnosed acute myeloid leukemia
PURPOSE This phase II trial is studying how well combination chemotherapy works in treating patients with newly diagnosed acute myeloid leukemia
Detailed Description:
OBJECTIVES
Determine the complete remission rate in patients with acute myelogenous leukemia treated with induction chemotherapy comprising mitoxantrone hydrochloride cytarabine and etoposide
Determine the feasibility and toxicity of this regimen when given to patients with newly diagnosed acute myelogenous leukemia
OUTLINE Patients receive induction chemotherapy comprising mitoxantrone hydrochloride IV on days 1-3 cytarabine IV continuously over 72 hours on days 1-3 and 8-10 and etoposide IV continuously over 72 hours on days 8-10 Patients also receive filgrastim G-CSF subcutaneously once daily beginning on day 4 and continuing until blood counts recover
PROJECTED ACCRUAL A total of 40 patients will be accrued for this study
Determine the complete remission rate in patients with acute myelogenous leukemia treated with induction chemotherapy comprising mitoxantrone hydrochloride cytarabine and etoposide
Determine the feasibility and toxicity of this regimen when given to patients with newly diagnosed acute myelogenous leukemia
OUTLINE Patients receive induction chemotherapy comprising mitoxantrone hydrochloride IV on days 1-3 cytarabine IV continuously over 72 hours on days 1-3 and 8-10 and etoposide IV continuously over 72 hours on days 8-10 Patients also receive filgrastim G-CSF subcutaneously once daily beginning on day 4 and continuing until blood counts recover
PROJECTED ACCRUAL A total of 40 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 |
|---|---|---|---|
| CASE-CCF-0645 | US NIH GrantContract | None | httpsreporternihgovquickSearchP30CA043703 |
| P30CA043703 | NIH | None | None |
| CASE-CCF-4409 | None | None | None |