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NCT00877656 Clinical Trial

HuMax-CD4 in Non-Cutaneous T-Cell Lymphoma

T Cell Lymphoma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00877656
Other study ID # Hx-CD4-109
Secondary ID
Status Completed
Phase Phase 2/Phase 3
First received
Last updated
Start date August 2005
Est. completion date December 2008

Study information
Verified date March 2024
Source Emergent BioSolutions
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 21
Est. completion date December 2008
Est. primary completion date January 2006
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design

Related Conditions & MeSH terms

Intervention

Biological:
• HuMax-CD4
Active treatment

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Emergent BioSolutions

References & Publications (1)

d'Amore F, Radford J, Relander T, Jerkeman M, Tilly H, Osterborg A, Morschhauser F, Gramatzki M, Dreyling M, Bang B, Hagberg H. Phase II trial of zanolimumab (HuMax-CD4) in relapsed or refractory non-cutaneous peripheral T cell lymphoma. Br J Haematol. 2010 Sep;150(5):565-73. doi: 10.1111/j.1365-2141.2010.08298.x. Epub 2010 Jul 14. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Efficacy as measured by survival and time to disease progression 12 months
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