Ignite Creation Date:
2024-05-05 @ 4:40 PM
Last Modification Date:
2024-10-26 @ 9:23 AM
Study NCT ID:
NCT00298467
Status:
WITHDRAWN
Last Update Posted:
2010-04-26
First Post:
2006-03-01
Brief Title:
MDX-060 in Patients With Relapsed or Refractory Classic Systemic or Primary Cutaneous Anaplastic Large Cell Lymphoma
Sponsor:
Bristol-Myers Squibb
Organization:
Bristol-Myers Squibb
Study Overview
Official Title:
An Open-label Fixed-dose Multicenter Phase II Study of MDX-060 in Patients With Relapsed or Refractory Classic Systemic or Primary Cutaneous Anaplastic Large Cell Lymphoma
Status:
WITHDRAWN
Status Verified Date:
2010-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
sponsor decision
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study is an open-label fixed-dose multicenter study of MDX-060 in patients with ALCL who have relapsed or refractory disease There will be 3 phases of this study Induction Maintenance and Follow-up Patients will be required to attend all protocol-required visits in the 4-week Induction Phase in which administration of MDX-060 will occur as well as other testing Patients who complete the Induction Phase may be eligible for additional MDX-060 treatment ever 2 months for 1 year in the Maintenance Phase Patients who complete the Maintenance Phase with a response of stable disease or better will be followed every 2 months for 1 year or until disease progression The purpose of this study is to determine objective response rate at Day 50 in patients with relapsed or refractory classic systemic ALCL or primary cutaneous ALCL treated with MDX-060 Other objectives will be evaluated
Detailed Description:
This study is an open-label fixed-dose multicenter study of MDX-060 in patients with ALCL who have relapsed or refractory disease There will be 3 phases of this study Induction Maintenance and Follow-up Patients will be required to attend all protocol-required visits in the 4-week Induction Phase in which administration of MDX-060 will occur as well as other testing Patients who complete the Induction Phase may be eligible for additional MDX-060 treatment ever 2 months for 1 year in the Maintenance Phase Patients who complete the Maintenance Phase with a response of stable disease or better will be followed every 2 months for 1 year or until disease progression
The primary objective of the study is to determine the objective response rate ORR at Day 50 in patients with relapsed or refractory classic systemic anaplastic large cell lymphoma csALCL or primary cutaneous ALCL pcALCL treated with MDX-060 The ORR will be based on an adaption of the NCI Response Criteria for Non-Hodgkins Lymphoma NHL for patients with csALCL and will be based on the Physicians Global Assessment PGA for patient with pcALCL
Secondary objectives include 1 characterizing progression-free survival PFS 2 determining response duration RD 3 characterizing the effect of MDX-060 on health-related Quality of Life QoL 4 evaluating patients with pcALCL using an adaption of the NCI Response Criteria for NHL 5 characterizing the immunogenicity of MDX-060 6 characterizing the safety of MDX-060 and 7 determining the best objective response rate BORR during the Maintenance Phase of the study
The primary objective of the study is to determine the objective response rate ORR at Day 50 in patients with relapsed or refractory classic systemic anaplastic large cell lymphoma csALCL or primary cutaneous ALCL pcALCL treated with MDX-060 The ORR will be based on an adaption of the NCI Response Criteria for Non-Hodgkins Lymphoma NHL for patients with csALCL and will be based on the Physicians Global Assessment PGA for patient with pcALCL
Secondary objectives include 1 characterizing progression-free survival PFS 2 determining response duration RD 3 characterizing the effect of MDX-060 on health-related Quality of Life QoL 4 evaluating patients with pcALCL using an adaption of the NCI Response Criteria for NHL 5 characterizing the immunogenicity of MDX-060 6 characterizing the safety of MDX-060 and 7 determining the best objective response rate BORR during the Maintenance Phase of the 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