NCT00877656

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
21

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Aug 2005

Typical duration for phase_2

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2005

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2006

Completed
2.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2008

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

March 25, 2009

Completed
14 days until next milestone

First Posted

Study publicly available on registry

April 8, 2009

Completed
Last Updated

March 18, 2024

Status Verified

March 1, 2024

Enrollment Period

5 months

First QC Date

March 25, 2009

Last Update Submit

March 15, 2024

Conditions

T Cell Lymphoma

Outcome Measures

Primary Outcomes (1)

  • Efficacy as measured by survival and time to disease progression

    12 months

Study Arms (1)

CD4

EXPERIMENTAL

Open label treatment arm

Biological: HuMax-CD4

Interventions

HuMax-CD4BIOLOGICAL

Active treatment

CD4

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

    PMID: 20629661BACKGROUND

MeSH Terms

Conditions

Lymphoma, T-Cell

Interventions

zanolimumab

Condition Hierarchy (Ancestors)

Lymphoma, Non-HodgkinLymphomaNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Study Officials

  • Abhay Patki, PhD

    Genmab

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

March 25, 2009

First Posted

April 8, 2009

Study Start

August 1, 2005

Primary Completion

January 1, 2006

Study Completion

December 1, 2008

Last Updated

March 18, 2024

Record last verified: 2024-03