HuMax-CD4 in Non-Cutaneous T-Cell Lymphoma

This study has been completed.
Sponsor:
Information provided by:
Emergent BioSolutions
ClinicalTrials.gov Identifier:
NCT00877656
First received: March 25, 2009
Last updated: November 20, 2012
Last verified: April 2009
  Purpose

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 Intervention Phase
T Cell Lymphoma
Biological: HuMax-CD4
Phase 2
Phase 3

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by Emergent BioSolutions:

Primary Outcome Measures:
  • Efficacy as measured by survival and time to disease progression [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Enrollment: 21
Study Start Date: August 2005
Study Completion Date: December 2008
Primary Completion Date: January 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: CD4
Open label treatment arm
Biological: HuMax-CD4
Active treatment

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00877656

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

No publications provided

Responsible Party: ICTM, Genmab
ClinicalTrials.gov Identifier: NCT00877656     History of Changes
Other Study ID Numbers: Hx-CD4-109
Study First Received: March 25, 2009
Last Updated: November 20, 2012
Health Authority: Denmark: Danish Medicines Agency
United Kingdom: Medicines and Healthcare Products Regulatory Agency
Sweden: Medical Products Agency
France: French Data Protection Authority
Germany: Federal Institute for Drugs and Medical Devices

Additional relevant MeSH terms:
Lymphoma
Lymphoma, T-Cell
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin

ClinicalTrials.gov processed this record on August 21, 2014