Ignite Creation Date:
2024-05-05 @ 4:58 PM
Last Modification Date:
2024-10-26 @ 9:26 AM
Study NCT ID:
NCT00354276
Status:
UNKNOWN
Last Update Posted:
2014-01-10
First Post:
2006-07-19
Brief Title:
VNP40101M Followed by Cytarabine in Treating Older Patients With Acute Myeloid Leukemia
Sponsor:
Vion Pharmaceuticals
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase II Study of Cloretazine VNP40101M for Elderly Patients With De Novo Poor Risk Acute Myelogenous Leukemia
Status:
UNKNOWN
Status Verified Date:
2009-05
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
RATIONALE Drugs used in chemotherapy such as VNP40101M and cytarabine work in different ways to stop the growth of cancer cells either by killing the cells or by stopping them from dividing Giving VNP40101M followed by cytarabine may kill more cancer cells
PURPOSE This phase II trial is studying how well VNP40101M followed by cytarabine works in treating older patients with acute myeloid leukemia
PURPOSE This phase II trial is studying how well VNP40101M followed by cytarabine works in treating older patients with acute myeloid leukemia
Detailed Description:
OBJECTIVES
Primary
Determine the complete response rate in older patients with poor-risk de novo acute myeloid leukemia treated with VNP40101M as induction therapy followed by cytarabine as consolidation therapy
Secondary
Determine the probability of overall survival leukemia-free survival and progression-free survival of patients treated with this regimen
Determine the safety of this regimen in these patients
OUTLINE This is an open-label multicenter study
Induction therapy Patients receive VNP40101M IV over 60 minutes on day 1 course 1 Patients without evidence of disease progression who have responding but residual disease receive a second course of VNP40101M once between days 35-60 Patients achieving complete response or partial response after induction therapy proceed to consolidation therapy
Consolidation therapy Beginning between days 45-90 patients receive cytarabine IV continuously over 5 days course 1 Patients may receive a second course of cytarabine at the discretion of the investigator
After completion of study treatment patients are followed periodically for up to 36 months
PROJECTED ACCRUAL A total of 85 patients will be accrued for this study
Primary
Determine the complete response rate in older patients with poor-risk de novo acute myeloid leukemia treated with VNP40101M as induction therapy followed by cytarabine as consolidation therapy
Secondary
Determine the probability of overall survival leukemia-free survival and progression-free survival of patients treated with this regimen
Determine the safety of this regimen in these patients
OUTLINE This is an open-label multicenter study
Induction therapy Patients receive VNP40101M IV over 60 minutes on day 1 course 1 Patients without evidence of disease progression who have responding but residual disease receive a second course of VNP40101M once between days 35-60 Patients achieving complete response or partial response after induction therapy proceed to consolidation therapy
Consolidation therapy Beginning between days 45-90 patients receive cytarabine IV continuously over 5 days course 1 Patients may receive a second course of cytarabine at the discretion of the investigator
After completion of study treatment patients are followed periodically for up to 36 months
PROJECTED ACCRUAL A total of 85 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 |
|---|---|---|---|
| EUDRACT-2006-001853-89 | None | None | None |
| VION-CLI-043 | None | None | None |