Ignite Creation Date:
2024-05-05 @ 11:25 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00035022
Status:
COMPLETED
Last Update Posted:
2006-01-13
First Post:
2002-05-02
Brief Title:
Study of Intravenous BCX-1777 in Relapsed or Refractory Aggressive T-Cell Leukemias or Lymphomas
Sponsor:
BioCryst Pharmaceuticals
Organization:
BioCryst Pharmaceuticals
Study Overview
Official Title:
Phase I-II Study of Intravenous BCX-1777 in Relapsed or Refractory Aggressive High Grade T-Cell Malignancies
Status:
COMPLETED
Status Verified Date:
2005-02
Last Known Status:
None
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:
The purpose of this study is to determine if intravenous BCX-1777 can be given safely to improve relapsed or refractory aggressive T-cell leukemias and lymphomas
Detailed Description:
Despite the great strides that have been made in improving the outcome with frontline programs of intensive chemotherapy in patients with aggressive T-cell malignancies the prognosis with relapsed or refractory T-cell leukemias or lymphomas is poor BCX-1777 is a purine nucleoside phosphorylase PNP inhibitor and a potential T-cell target therapy
The purpose of the phase I portion of the study is to determine the maximum tolerated dose MTD of BCX-1777 and the dose to be studied in the phase II portion of the study
The purpose of the phase II portion of the study is to determine the safety and efficacy of BCX-1777 in patients with relapsed or refractory aggressive T-cell malignancies
Patients who respond to BCX-1777 or have stable disease may be eligible to receive an additional course of treatment
The purpose of the phase I portion of the study is to determine the maximum tolerated dose MTD of BCX-1777 and the dose to be studied in the phase II portion of the study
The purpose of the phase II portion of the study is to determine the safety and efficacy of BCX-1777 in patients with relapsed or refractory aggressive T-cell malignancies
Patients who respond to BCX-1777 or have stable disease may be eligible to receive an additional course of treatment
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