HuMax-CD4 in Non-Cutaneous T-Cell Lymphoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00877656
Recruitment Status : Completed
First Posted : April 8, 2009
Last Update Posted : November 22, 2012
Information provided by:
Emergent BioSolutions

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.

Condition or disease Intervention/treatment Phase
T Cell Lymphoma Biological: HuMax-CD4 Phase 2 Phase 3

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 21 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : August 2005
Primary Completion Date : January 2006
Study Completion Date : December 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma
U.S. FDA Resources

Arm Intervention/treatment
Experimental: CD4
Open label treatment arm
Biological: HuMax-CD4
Active treatment

Primary Outcome Measures :
  1. Efficacy as measured by survival and time to disease progression [ Time Frame: 12 months ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00877656

Sponsors and Collaborators
Emergent BioSolutions
Study Chair: Abhay Patki, PhD Genmab

Responsible Party: ICTM, Genmab Identifier: NCT00877656     History of Changes
Other Study ID Numbers: Hx-CD4-109
First Posted: April 8, 2009    Key Record Dates
Last Update Posted: November 22, 2012
Last Verified: April 2009

Additional relevant MeSH terms:
Lymphoma, T-Cell
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs