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

Phase 2

Completed

• Conditions: Cutaneous T-Cell Lymphoma
• Interventions: Drug: HuMax-CD4

• Registration Number: NCT00071084
• Lead Sponsor: Genmab

Brief Summary

The purpose of this trial is to determine the effect of HuMax-CD4, as a treatment for advanced stage (late stage) cutaneous T-cell lymphoma (CTCL). Almost all participants who are affected by late stage CTCL have many 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. The response rates, duration of responses, relief of symptoms, and safety profile of HuMax-CD4 will be evaluated during this trial.

Detailed Description

Not available

Study Timeline

• Study Start: 2003-05-27
• Study First Submitted: 2003-10-10
• Study First Submitted QC: 2003-10-14
• Study First Posted: 2003-10-15
• Primary Completion: 2004-06-29
• Study Completion: 2004-06-29
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-26
• Last Update Posted: 2023-04-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 22

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
HuMax-CD4 280 milligrams (mg)	HuMax-CD4	-
HuMax-CD4 980 mg	HuMax-CD4	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Percentage of Participants With Physician's Global Assessment of Clinical Condition (PGA) Response	Up to 20 weeks
Time to Response	From first dose to achieving a response (up to approximately 12 weeks)
Number of Participants with Adverse Events (AEs) and Graded as per Severity	From Baseline (Day 0) up to end of study (Week 20)
Number of Participants With Positive Human Anti Human Antibodies (HAHA) Titres	Up to Week 20
Percentage of Participants with Change From Baseline in Total Body Surface Area (BSA)	Baseline up to Week 21
Percentage of Participants with Change from Baseline in Participant's Assessment of Pruritus Scale	Baseline, up to Week 20	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.
Response Duration	From achieving first response to last response/until relapse (up to approximately 22 weeks)
Time to Disease Progression	From first dose until disease progressed (Up to 16 weeks)
Change from Baseline in Physician's Erythroderma Severity Assessment	Baseline, Week 20

Trial Locations

Locations (2)

Stanford University Med Ctr., Dept of Dermatology; 🇺🇸 Stanford, California, United States

University of Texas, M.D. Anderson Cancer Center; 🇺🇸 Houston, Texas, United States