Ignite Creation Date:
2024-05-05 @ 11:53 AM
Last Modification Date:
2024-10-26 @ 9:15 AM
Study NCT ID:
NCT00161590
Status:
COMPLETED
Last Update Posted:
2008-10-22
First Post:
2005-09-07
Brief Title:
Study of CHOP Campath for T-Cell Null Cell or Natural Killer NK-Cell Lymphoma
Sponsor:
Weill Medical College of Cornell University
Organization:
Weill Medical College of Cornell University
Study Overview
Official Title:
Phase I Study of CHOP Plus Campath C-CHOP for the Treatment of T-Cell Null-Cell and NK-Cell Lymphomas
Status:
COMPLETED
Status Verified Date:
2008-10
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:
Primary Objective
To determine the toxicity profile and tolerability of alemtuzumab Campath when administered in combination with cyclophosphamide doxorubicin vincristine and prednisone CHOP chemotherapy C-CHOP in patients with T-cell null-cell and NK-cell lymphomas
Secondary Objectives
To evaluate response rate overall survival and disease-free survival in patients with T-cell null-cell and NK-cell lymphomas treated with Campath CHOP chemotherapy
To assess the incidence of cytomegalovirus CMV reactivation in patients with these lymphomas treated with the Campath CHOP combination
To determine features which might be predictive of resistance to treatment or predictive of relapse including the absence of glycosylphosphatidylinositol GPI-linked proteins
To determine the toxicity profile and tolerability of alemtuzumab Campath when administered in combination with cyclophosphamide doxorubicin vincristine and prednisone CHOP chemotherapy C-CHOP in patients with T-cell null-cell and NK-cell lymphomas
Secondary Objectives
To evaluate response rate overall survival and disease-free survival in patients with T-cell null-cell and NK-cell lymphomas treated with Campath CHOP chemotherapy
To assess the incidence of cytomegalovirus CMV reactivation in patients with these lymphomas treated with the Campath CHOP combination
To determine features which might be predictive of resistance to treatment or predictive of relapse including the absence of glycosylphosphatidylinositol GPI-linked proteins
Detailed Description:
None
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