HuMax-CD4 in Non-Cutaneous T-Cell Lymphoma

Emergent BioSolutions

Status and phase: Completed; Phase 3; Phase 2

Conditions: T Cell Lymphoma

Treatments: Biological: HuMax-CD4

Study type: Interventional

Funder types: Industry

Identifiers

NCT00877656

Hx-CD4-109

Details and patient eligibility

About

The purpose of this study is to assess the safety and efficacy of treatment of non-cutaneous T-cell lymphoma with treatment with CD4.

Full 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.

Enrollment: 21 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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21 participants in 1 patient group

CD4

Experimental group

Description:

Open label treatment arm

Treatment:

Biological: HuMax-CD4