HuMax-CD4 in Non-Cutaneous T-Cell Lymphoma

Phase 2

Completed

• Conditions: T Cell Lymphoma
• Interventions: Biological: HuMax-CD4

• Registration Number: NCT00877656
• Lead Sponsor: Emergent BioSolutions

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.

Study Timeline

• Study Start: 2005-08
• Primary Completion: 2006-01
• Study Completion: 2008-12
• Study First Submitted: 2009-03-25
• Study First Submitted QC: 2009-04-07
• Study First Posted: 2009-04-08
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-15
• Last Update Posted: 2024-03-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 21

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.

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
CD4	HuMax-CD4	Open label treatment arm

Primary Outcome Measures

Name	Time	Method
Efficacy as measured by survival and time to disease progression	12 months