Ignite Creation Date:
2024-05-05 @ 12:10 PM
Last Modification Date:
2024-10-26 @ 9:21 AM
Study NCT ID:
NCT00268242
Status:
TERMINATED
Last Update Posted:
2018-02-22
First Post:
2005-12-20
Brief Title:
Gemcitabine and Mitoxantrone in Treating Patients With Relapsed Acute Myeloid Leukemia
Sponsor:
The Cleveland Clinic
Organization:
The Cleveland Clinic
Study Overview
Official Title:
A Phase II Study of Gemcitabine Mitoxantrone in Patients With Acute Myeloid Leukemia in First Relapse
Status:
TERMINATED
Status Verified Date:
2015-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
If 5 of the initial 18 patients had a CR the study would be stopped Only 5 patients 21 of 24 enrolled patients had a CR so the study was terminated
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 gemcitabine and mitoxantrone 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 giving gemcitabine together with mitoxantrone works in treating patients with relapsed acute myeloid leukemia
PURPOSE This phase II trial is studying how well giving gemcitabine together with mitoxantrone works in treating patients with relapsed acute myeloid leukemia
Detailed Description:
OBJECTIVES
Primary
Determine the complete response CR rate CR and incomplete blood count recovery CRi of patients with acute myeloid leukemia in first relapse treated with gemcitabine hydrochloride and mitoxantrone hydrochloride
Secondary
Evaluate disease free and overall survival of patients with acute myeloid leukemia in first relapse treated with this particular chemotherapy regimen
Assess hematologic and non-hematologic toxicity associated with this regimen
Assess laboratory correlates of drug resistance in patients with relapsed acute myeloid leukemia
Assess the percentage of patients receiving subsequent bone marrow transplantation
OUTLINE This is an open-label multicenter study
Patients receive gemcitabine hydrochloride IV over 12 hours on day 1 and mitoxantrone hydrochloride IV over 30-60 minutes on days 1 2 and 3 After completion of a single course of therapy patients who achieve a complete response may receive 1 additional course of therapy at the discretion of the treating physician
After completion of study treatment patients are followed periodically for survival
PROJECTED ACCRUAL A total of 40 patients will be accrued for this study
Primary
Determine the complete response CR rate CR and incomplete blood count recovery CRi of patients with acute myeloid leukemia in first relapse treated with gemcitabine hydrochloride and mitoxantrone hydrochloride
Secondary
Evaluate disease free and overall survival of patients with acute myeloid leukemia in first relapse treated with this particular chemotherapy regimen
Assess hematologic and non-hematologic toxicity associated with this regimen
Assess laboratory correlates of drug resistance in patients with relapsed acute myeloid leukemia
Assess the percentage of patients receiving subsequent bone marrow transplantation
OUTLINE This is an open-label multicenter study
Patients receive gemcitabine hydrochloride IV over 12 hours on day 1 and mitoxantrone hydrochloride IV over 30-60 minutes on days 1 2 and 3 After completion of a single course of therapy patients who achieve a complete response may receive 1 additional course of therapy at the discretion of the treating physician
After completion of study treatment patients are followed periodically for survival
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 |
|---|---|---|---|
| P30CA043703 | NIH | None | None |
| CASE-CCF-7725 | OTHER | Cleveland Clinic | httpsreporternihgovquickSearchP30CA043703 |