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
18 Years
N/A
Both
T Cell Lymphoma
Trial Information
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
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.
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.
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Efficacy as measured by survival and time to disease progression
Outcome Time Frame:
12 months
Safety Issue:
No
Principal Investigator
Abhay Patki, PhD
Investigator Role:
Study Chair
Investigator Affiliation:
Genmab
Authority:
Denmark: Danish Medicines Agency
Study ID:
Hx-CD4-109
NCT ID:
NCT00877656
Start Date:
August 2005
Completion Date:
December 2008
Related Keywords:
- T Cell Lymphoma
- Lymphoma
- Lymphoma, T-Cell
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