HuMax-CD4 in Non-Cutaneous T-Cell Lymphoma
The purpose of this study is to assess the safety and efficacy of treatment of non-cutaneous T-cell lymphoma with treatment with CD4.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|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|
- Efficacy as measured by survival and time to disease progression [ Time Frame: 12 months ] [ Designated as safety issue: No ]
|Study Start Date:||August 2005|
|Study Completion Date:||December 2008|
|Primary Completion Date:||January 2006 (Final data collection date for primary outcome measure)|
Open label treatment arm
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.