Back to resultsClinical Trial of HuMax-CD4, a New Drug to Treat Early Stage T-Cell Lymphoma in the Skin.
Primary Purpose
Cutaneous T-Cell Lymphoma
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
HuMax-CD4
HuMax-CD4
Sponsored by
About this trial
This is an interventional treatment trial for Cutaneous T-Cell Lymphoma focused on measuring Skin cancer, Lymphoma, Mycosis fungoides, Sezary syndrome
Eligibility Criteria
Inclusion criteria 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. Histopathological evidence of large cell transformation or poorly differentiated tumors or prior treatment with anti-CD4 monoclonal antibodies excluded participants from inclusion in the study. Exclusion Criteria 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. Note: Other protocol defined Inclusion and Exclusion criteria may apply.
Sites / Locations
- Stanford University Med. Ctr., Dept. of Dermatology
- University of Texas, M.D. Anderson Cancer Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
HuMax-CD4 280 milligrams (mg)
HuMax-CD4 560 mg
Arm Description
Outcomes
Primary Outcome Measures
Percentage of Participants Who Achieved Complete and Partial Responses Assessed by Composite Assessment of Index Lesion Disease Severity (CA) Scale
Secondary Outcome Measures
Number of Participants with Adverse Events (AEs)
Percentage of Participants With Physician's Global Assessment of Clinical Condition (PGA) Response at Weeks 2, 4 and 12
Percentage of Participants With Change from Baseline in Participant's Assessment of Pruritus Scale
The participants were assessed pruritus on a 5-point scale from 0-4: 0. No complaint of itching on lesion; 1. Mild: Occasional transient itching on lesion; 2. Moderate: Frequent itching, every 1-3 hours; reflex scratching; 3. Severe: Compelling itching; interrupts daily activities; must be scratched; 4. Very severe: Unrelieved itching: prevents routine activities; awakens patient from sleep.
Time to Response
Response Duration
Time to Disease Progression
Percentage of Participants with Change From Baseline in Total Body Surface Area (BSA)
Number of Participants With Positive Human Anti Human Antibodies (HAHA) Titres
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00071071
Brief Title
Clinical Trial of HuMax-CD4, a New Drug to Treat Early Stage T-Cell Lymphoma in the Skin.
Official Title
An Open-Label Therapeutic Exploratory Clinical Trial of HuMax-CD4, a Fully Human Monoclonal Anti-CD4 Antibody, in Patients With Refractory or Persistent Early Stage (IA-IIA) Cutaneous T-Cell Lymphoma
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
April 30, 2003 (Actual)
Primary Completion Date
May 5, 2004 (Actual)
Study Completion Date
May 5, 2004 (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Genmab
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cutaneous T-Cell Lymphoma
Keywords
Skin cancer, Lymphoma, Mycosis fungoides, Sezary syndrome
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
25 (Actual)
8. Arms, Groups, and Interventions
Arm Title
HuMax-CD4 280 milligrams (mg)
Arm Type
Experimental
Arm Title
HuMax-CD4 560 mg
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
HuMax-CD4
Other Intervention Name(s)
Zanolimumab
Intervention Description
HuMax-CD4 280 mg was administered as a subcutaneous (SC) infusion once daily (OD) up to 18 weeks.
Intervention Type
Drug
Intervention Name(s)
HuMax-CD4
Other Intervention Name(s)
Zanolimumab
Intervention Description
HuMax-CD4 560 mg was administered as a SC infusion OD up to 18 weeks.
Primary Outcome Measure Information:
Title
Percentage of Participants Who Achieved Complete and Partial Responses Assessed by Composite Assessment of Index Lesion Disease Severity (CA) Scale
Time Frame
Up to 20 weeks
Secondary Outcome Measure Information:
Title
Number of Participants with Adverse Events (AEs)
Time Frame
From Baseline (Day 0) up to end of study (Week 20)
Title
Percentage of Participants With Physician's Global Assessment of Clinical Condition (PGA) Response at Weeks 2, 4 and 12
Time Frame
At Weeks 2, 4 and 12
Title
Percentage of Participants With Change from Baseline in Participant's Assessment of Pruritus Scale
Description
The participants were assessed pruritus on a 5-point scale from 0-4: 0. No complaint of itching on lesion; 1. Mild: Occasional transient itching on lesion; 2. Moderate: Frequent itching, every 1-3 hours; reflex scratching; 3. Severe: Compelling itching; interrupts daily activities; must be scratched; 4. Very severe: Unrelieved itching: prevents routine activities; awakens patient from sleep.
Time Frame
Baseline, up to Week 20
Title
Time to Response
Time Frame
From first dose to achieving a response (up to approximately 11 weeks)
Title
Response Duration
Time Frame
From achieving first response to last response/until relapse (up to approximately 92 weeks)
Title
Time to Disease Progression
Time Frame
From first dose until disease progressed (Up to 20 weeks)
Title
Percentage of Participants with Change From Baseline in Total Body Surface Area (BSA)
Time Frame
Baseline up to Week 20
Title
Number of Participants With Positive Human Anti Human Antibodies (HAHA) Titres
Time Frame
Up to Week 20
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria
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.
Histopathological evidence of large cell transformation or poorly differentiated tumors or prior treatment with anti-CD4 monoclonal antibodies excluded participants from inclusion in the study.
Exclusion Criteria
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.
Note: Other protocol defined Inclusion and Exclusion criteria may apply.
Facility Information:
Facility Name
Stanford University Med. Ctr., Dept. of Dermatology
City
Stanford
State/Province
California
ZIP/Postal Code
94305-5152
Country
United States
Facility Name
University of Texas, M.D. Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030-4009
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Clinical Trial of HuMax-CD4, a New Drug to Treat Early Stage T-Cell Lymphoma in the Skin.
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