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

Genmab22 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Cutaneous T-Cell Lymphoma

Interventions

HuMax-CD4DRUG

HuMax-CD4 280 mg was administered as a subcutaneous (SC) infusion once daily (OD) up to 16 weeks.

HuMax-CD4DRUG

HuMax-CD4 980 mg was administered as a SC infusion OD up to 16 weeks.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion criteria * Medical diagnosis of CTCL, and positivity for the CD4 receptor. * Late stage CTCL. * Have received at least one prior anti-cancer therapy with inadequate effect. * World Health Organization (WHO) performance status 0,1 or 2 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.

Locations (5)

Stanford University Med Ctr., Dept of Dermatology

Stanford, California, United States

University of Texas, M.D. Anderson Cancer Center

Houston, Texas, United States

Unnamed facility

Münster, Germany

Unnamed facility

Stockholm, Sweden

Outcomes

Primary Outcomes

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 Outcomes

Number of Participants with Adverse Events (AEs) and Graded as per Severity

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

Percentage of Participants With Physician's Global Assessment of Clinical Condition (PGA) Response

Time frame: Up to 20 weeks

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 frame: Baseline, up to Week 20

Time to Response

Time frame: From first dose to achieving a response (up to approximately 12 weeks)

Response Duration

Time frame: From achieving first response to last response/until relapse (up to approximately 22 weeks)

Time to Disease Progression

Time frame: From first dose until disease progressed (Up to 16 weeks)

Percentage of Participants with Change From Baseline in Total Body Surface Area (BSA)

Time frame: Baseline up to Week 21

Data from ClinicalTrials.gov

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