NCT00071071

Brief Summary

The purpose of this trial is to determine the effect of HuMax-CD4 as a treatment for early stage cutaneous T-cell lymphoma (CTCL). Almost all participants who are affected by CTCL have cancerous cells which bear a receptor called CD4. HuMax-CD4 is an investigational drug directed against this receptor. There is no placebo in this trial; all participants will be treated with HuMax-CD4. During the trial, the response rates, duration of responses, relief of symptoms, and safety profile of HuMax-CD4 will be evaluated.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
25

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Apr 2003

Shorter than P25 for phase_2

Geographic Reach
1 country

2 active sites

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

April 30, 2003

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

October 10, 2003

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 15, 2003

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 5, 2004

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 5, 2004

Completed
Last Updated

May 18, 2023

Status Verified

May 1, 2023

Enrollment Period

1 year

First QC Date

October 10, 2003

Last Update Submit

May 16, 2023

Conditions

Cutaneous T-Cell Lymphoma

Keywords

Skin cancerLymphomaMycosis fungoidesSezary syndrome

Outcome Measures

Primary Outcomes (1)

  • Percentage of Participants Who Achieved Complete and Partial Responses Assessed by Composite Assessment of Index Lesion Disease Severity (CA) Scale

    Up to 20 weeks

Secondary Outcomes (8)

  • Number of Participants with Adverse Events (AEs)

    From Baseline (Day 0) up to end of study (Week 20)

  • Percentage of Participants With Physician's Global Assessment of Clinical Condition (PGA) Response at Weeks 2, 4 and 12

    At Weeks 2, 4 and 12

  • Percentage of Participants With Change from Baseline in Participant's Assessment of Pruritus Scale

    Baseline, up to Week 20

  • Time to Response

    From first dose to achieving a response (up to approximately 11 weeks)

  • Response Duration

    From achieving first response to last response/until relapse (up to approximately 92 weeks)

  • +3 more secondary outcomes

Study Arms (2)

HuMax-CD4 280 milligrams (mg)

EXPERIMENTAL
Drug: HuMax-CD4

HuMax-CD4 560 mg

EXPERIMENTAL
Drug: HuMax-CD4

Interventions

HuMax-CD4DRUG

HuMax-CD4 280 mg was administered as a subcutaneous (SC) infusion once daily (OD) up to 18 weeks.

Also known as: Zanolimumab
HuMax-CD4 280 milligrams (mg)

Eligibility Criteria

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

You may qualify if:

  • Medical diagnosis of CTCL, and positivity for the CD4 receptor.
  • Early stage CTCL
  • Have received at least two prior therapies with inadequate effect, including phototherapy and/or electron beam, and/or chemotherapy.

You may not qualify if:

  • Certain rare types of CTCL.
  • Previous treatment with other anti-CD4 medications.
  • More than two previous treatments with systemic chemotherapy.
  • Certain anti-psoriasis or anti-cancer therapies within the last 4 weeks before entering this trial.
  • Some types of steroid treatments less than two weeks before entering the trial.
  • Prolonged exposure to sunlight or UV light during the trial.
  • Other cancer diseases, except certain skin cancers or cervix cancer.
  • Chronic infectious disease requiring medication.
  • Certain serious medical conditions, including kidney or liver disease, some psychiatric illnesses, and stomach, lung, heart, hormonal, nerve or blood diseases.
  • Pregnant or breast-feeding women.
  • Women of childbearing age who are unable or unwilling to use an IUD or hormonal birth control during the whole trial.
  • If you are participating in another trial with a different new drug 4 weeks before you enter this trial.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Stanford University Med. Ctr., Dept. of Dermatology

Stanford, California, 94305-5152, United States

Location

University of Texas, M.D. Anderson Cancer Center

Houston, Texas, 77030-4009, United States

Location

MeSH Terms

Conditions

Lymphoma, T-Cell, CutaneousSkin NeoplasmsLymphomaMycosis FungoidesSezary Syndrome

Interventions

zanolimumab

Condition Hierarchy (Ancestors)

Lymphoma, T-CellLymphoma, Non-HodgkinNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesNeoplasms by SiteSkin DiseasesSkin and Connective Tissue Diseases

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 10, 2003

First Posted

October 15, 2003

Study Start

April 30, 2003

Primary Completion

May 5, 2004

Study Completion

May 5, 2004

Last Updated

May 18, 2023

Record last verified: 2023-05

Locations

US(2)