HuMax-CD4 in Non-Cutaneous T-Cell Lymphoma

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 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, , 

NCT ID

NCT00877656

Organization ID

Hx-CD4-109

Study Sponsor

Emergent BioSolutions

Study Sponsor

Abhay Patki, PhD, Study Chair, Genmab

Verification Date

April 2009