Brief Title
HuMax-CD4 in Non-Cutaneous T-Cell Lymphoma
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
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.
Study Phase
Phase 2/Phase 3
Study Type
Interventional
Primary Outcome
Efficacy as measured by survival and time to disease progression
Condition
T Cell Lymphoma
Intervention
HuMax-CD4
Study Arms / Comparison Groups
CD4
Description: Open label treatment arm
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Biological
Estimated Enrollment
21
Start Date
August 2005
Completion Date
December 2008
Primary Completion Date
January 2006
Eligibility Criteria
Inclusion Criteria: - Diagnostic biopsy of non cutaneous T Cell lymphoma with positive phenotype - Relapsed or refractory to minimum of one course of chemotherapy - Study is closed to enrollment.
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Abhay Patki, PhD, ,
Administrative Informations
NCT ID
NCT00877656
Organization ID
Hx-CD4-109
Study Sponsor
Emergent BioSolutions
Study Sponsor
Abhay Patki, PhD, Study Chair, Genmab
Verification Date
April 2009