HuMax-CD4 in Non-Cutaneous T-Cell Lymphoma

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

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Key information

Conditions

T Cell Lymphoma Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Lymphatic Diseases Lymphoma Lymphoma, Non-Hodgkin Lymphoma, T-Cell Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

HuMax-CD4

Biological

Active treatment

Primary outcomes

Efficacy as measured by survival and time to disease progression

Time frame: 12 months

Sponsors and collaborators

Lead sponsor

Emergent BioSolutions

Industry

Registry information

Official study 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

Important dates

Study start: 2005
Primary completion: 2006
Study completion: 2008
First posted: Apr 8, 2009
Registry last updated: Mar 18, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed