HuMax-CD4 in Non-Cutaneous T-Cell Lymphoma

NCT ID: NCT00877656

Last Updated: 2024-03-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

21 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-08-31

Study Completion Date

2008-12-31

Brief Summary

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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

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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.

Conditions

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T Cell Lymphoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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CD4

Open label treatment arm

Group Type EXPERIMENTAL

HuMax-CD4

Intervention Type BIOLOGICAL

Active treatment

Interventions

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HuMax-CD4

Active treatment

Intervention Type BIOLOGICAL

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Emergent BioSolutions

INDUSTRY

Sponsor Role lead

Responsible Party

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Genmab

Principal Investigators

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Abhay Patki, PhD

Role: STUDY_CHAIR

Genmab

References

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d'Amore F, Radford J, Relander T, Jerkeman M, Tilly H, Osterborg A, Morschhauser F, Gramatzki M, Dreyling M, Bang B, Hagberg H. Phase II trial of zanolimumab (HuMax-CD4) in relapsed or refractory non-cutaneous peripheral T cell lymphoma. Br J Haematol. 2010 Sep;150(5):565-73. doi: 10.1111/j.1365-2141.2010.08298.x. Epub 2010 Jul 14.

Reference Type BACKGROUND
PMID: 20629661 (View on PubMed)

Other Identifiers

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Hx-CD4-109

Identifier Type: -

Identifier Source: org_study_id

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