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HuMax-CD4 in Non-Cutaneous T-Cell Lymphoma

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

Status
Completed
Phases
Phase 2Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00877656
Enrollment
21
Registered
2009-04-08
Start date
2005-08-31
Completion date
2008-12-31
Last updated
2024-03-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

T Cell Lymphoma

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.

Interventions

BIOLOGICALHuMax-CD4

Active treatment

Sponsors

Emergent BioSolutions
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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.

Design outcomes

Primary

MeasureTime frame
Efficacy as measured by survival and time to disease progression12 months

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026