Ignite Creation Date:
2025-12-24 @ 11:24 PM
Ignite Modification Date:
2025-12-27 @ 8:53 PM
Study NCT ID:
NCT00877656
Status:
COMPLETED
Last Update Posted:
2024-03-18
First Post:
2009-03-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
HuMax-CD4 in Non-Cutaneous T-Cell Lymphoma
Sponsor:
Emergent BioSolutions
Organization:
Study Overview
Official Title:
An Open-Label Therapeutic Exploratory Clinical Trial of HuMax-CD4, a Fully Human Monoclonal Anti-CD4 Antibody, in Patients With Refractory or Relapsed Non-Cutaneous CD4+ T-Cell Lymphoma
Status:
COMPLETED
Status Verified Date:
2024-03
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 assess the safety and efficacy of treatment of non-cutaneous T-cell lymphoma with treatment with CD4.
Detailed Description:
The study is closed and all subjects have completed treatment.
The study is to evaluate the safety and efficacy of Humax CD4 with CHO vs CHO alone in subjects with non-cutaneous T cell lymphoma. The primary efficacy will be evaluated by time to relapse.
The study is to evaluate the safety and efficacy of Humax CD4 with CHO vs CHO alone in subjects with non-cutaneous T cell lymphoma. The primary efficacy will be evaluated by time to relapse.
Study Oversight
Has Oversight DMC:
False
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?: