Back to resultsHuMax-CD4 in Non-Cutaneous T-Cell Lymphoma
Primary Purpose
T Cell Lymphoma
Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
HuMax-CD4
Sponsored by
About this trial
This is an interventional treatment trial for T Cell Lymphoma
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.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
CD4
Arm Description
Open label treatment arm
Outcomes
Primary Outcome Measures
Efficacy as measured by survival and time to disease progression
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00877656
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
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Completed
Study Start Date
August 2005 (undefined)
Primary Completion Date
January 2006 (Actual)
Study Completion Date
December 2008 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Emergent BioSolutions
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
T Cell Lymphoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
21 (Actual)
8. Arms, Groups, and Interventions
Arm Title
CD4
Arm Type
Experimental
Arm Description
Open label treatment arm
Intervention Type
Biological
Intervention Name(s)
HuMax-CD4
Intervention Description
Active treatment
Primary Outcome Measure Information:
Title
Efficacy as measured by survival and time to disease progression
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Abhay Patki, PhD
Organizational Affiliation
Genmab
Official's Role
Study Chair
12. IPD Sharing Statement
Citations:
PubMed Identifier
20629661
Citation
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.
Results Reference
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Learn more about this trial
HuMax-CD4 in Non-Cutaneous T-Cell Lymphoma
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