Ignite Creation Date:
2024-05-05 @ 11:49 AM
Last Modification Date:
2024-10-26 @ 9:14 AM
Study NCT ID:
NCT00144963
Status:
COMPLETED
Last Update Posted:
2019-12-12
First Post:
2005-09-01
Brief Title:
Liposomal Vincristine Plus Dexamethasone in Patients With Relapsed or Refractory Acute Lymphoblastic Leukemia
Sponsor:
Acrotech Biopharma Inc
Organization:
Acrotech Biopharma Inc
Study Overview
Official Title:
Phase I-II Study of Liposomal Vincristine VSLI and Dexamethasone in Relapsed or Refractory Acute Lymphoblastic Leukemia
Status:
COMPLETED
Status Verified Date:
2019-12
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:
The purpose of this study is to find the highest safe dose and to assess the anti-tumor effect of liposomal vincristine with dexamethasone in patients with relapsed or refractory acute lymphoblastic leukemia ALL
Detailed Description:
OBJECTIVES
Determine the maximum tolerated dose MTD of liposomal vincristine given with dexamethasone in patients with relapsed or refractory acute lymphoblastic leukemia ALL
Determine the efficacy of liposomal vincristine given with dexamethasone in these patients
Determine the maximum tolerated dose MTD of liposomal vincristine given with dexamethasone in patients with relapsed or refractory acute lymphoblastic leukemia ALL
Determine the efficacy of liposomal vincristine given with dexamethasone in these patients
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