Clinical Trial of HuMax-CD4, a New Drug to Treat Early Stage T-Cell Lymphoma in the Skin.

Cutaneous T-Cell Lymphoma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00071071
• Other study ID #: Hx-CD4-007
• Status: Completed
• Phase: Phase 2
• Start date: April 30, 2003
• Est. completion date: May 5, 2004

Study information

• Verified date: May 2023
• Source: Genmab
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: May 5, 2004
• Est. primary completion date: May 5, 2004
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cutaneous T-Cell Lymphoma
• Lymphoma
• Lymphoma, T-Cell
• Lymphoma, T-Cell, Cutaneous
• Lymphoma, T-Cell, Peripheral

Intervention

Drug:
• HuMax-CD4
HuMax-CD4 280 mg was administered as a subcutaneous (SC) infusion once daily (OD) up to 18 weeks.
• HuMax-CD4
HuMax-CD4 560 mg was administered as a SC infusion OD up to 18 weeks.

Locations

Country	Name	City	State
United States	University of Texas, M.D. Anderson Cancer Center	Houston	Texas
United States	Stanford University Med. Ctr., Dept. of Dermatology	Stanford	California

Sponsors (1)

Lead Sponsor	Collaborator
Genmab

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Number of Participants with Adverse Events (AEs)		From Baseline (Day 0) up to end of study (Week 20)
Secondary	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
Secondary	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.	Baseline, up to Week 20
Secondary	Time to Response		From first dose to achieving a response (up to approximately 11 weeks)
Secondary	Response Duration		From achieving first response to last response/until relapse (up to approximately 92 weeks)
Secondary	Time to Disease Progression		From first dose until disease progressed (Up to 20 weeks)
Secondary	Percentage of Participants with Change From Baseline in Total Body Surface Area (BSA)		Baseline up to Week 20
Secondary	Number of Participants With Positive Human Anti Human Antibodies (HAHA) Titres		Up to Week 20