Cutaneous T-Cell LymphomaPhase 2NCT00071071
Clinical Trial of HuMax-CD4, a New Drug to Treat Early Stage T-Cell Lymphoma in the Skin.
A Phase 2 study testing HuMax-CD4 in people with Cutaneous T-Cell Lymphoma, run by Genmab at 2 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cutaneous T-Cell Lymphoma
- What is being tested?
- HuMax-CD4
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 2 sitesUnited States
- Study dates
- 30 Apr 2003to 5 May 2004
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Texas, M.D. Anderson Cancer Center
Houston, Texas, 77030-4009
Stanford University Med. Ctr., Dept. of Dermatology
Stanford, California, 94305-5152
About this study
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
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.
- Conditions
- Cutaneous T-Cell Lymphoma
- Being tested
- HuMax-CD4
- Keywords
- Skin cancer, Lymphoma, Mycosis fungoides, Sezary syndrome
- Medical subject headings
- Lymphoma, T-Cell, Cutaneous, Skin Neoplasms, Lymphoma, Mycosis Fungoides, Sezary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HuMax-CD4Drug
Also called Zanolimumab
HuMax-CD4 280 mg was administered as a subcutaneous (SC) infusion once daily (OD) up to 18 weeks.
HuMax-CD4Drug
Also called Zanolimumab
HuMax-CD4 560 mg was administered as a SC infusion OD up to 18 weeks.
| Study group | Role | What they receive |
|---|---|---|
| HuMax-CD4 280 milligrams (mg) | Experimental | Not described Receives: Drug: HuMax-CD4 |
| HuMax-CD4 560 mg | Experimental | Not described Receives: Drug: HuMax-CD4 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants Who Achieved Complete and Partial Responses Assessed by Composite Assessment of Index Lesion Disease Severity (CA) Scale
Measured: Up to 20 weeks
Secondary outcomes (8)
Number of Participants with Adverse Events (AEs)
Measured: 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
Measured: 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.
Measured: Baseline, up to Week 20
Time to Response
Measured: From first dose to achieving a response (up to approximately 11 weeks)
Response Duration
Measured: From achieving first response to last response/until relapse (up to approximately 92 weeks)
Time to Disease Progression
Measured: From first dose until disease progressed (Up to 20 weeks)
Percentage of Participants with Change From Baseline in Total Body Surface Area (BSA)
Measured: Baseline up to Week 20
Number of Participants With Positive Human Anti Human Antibodies (HAHA) Titres
Measured: Up to Week 20
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2003 (estimated)
- Study start30 Apr 2003
- Primary completion5 May 2004
- Study completion5 May 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cutaneous T-Cell LymphomaStudies of the same condition, open and under way.
- More trials run by GenmabThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Genmab
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00071071
- Sponsor's protocol ID
- Hx-CD4-007
- Status last verified
- May 2023
- First submitted
- 10 Oct 2003
- Last updated
- 18 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00071071
- Acronym / sponsor ID
- Hx-CD4-007
- Conditions
- Cutaneous T-Cell Lymphoma
- Keywords
- Skin cancer, Lymphoma, Mycosis fungoides, Sezary syndrome
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- GenmabIndustry (pharma, biotech, devices)
- Study start
- 30 Apr 2003 (actual)
- Primary completion
- 5 May 2004 (actual)
- Study completion
- 5 May 2004
- First posted
- 15 Oct 2003 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HuMax-CD4 280 milligrams (mg) | Experimental | Drug: HuMax-CD4 |
| HuMax-CD4 560 mg | Experimental | Drug: HuMax-CD4 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (13 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HuMax-CD4Also: ZanolimumabHuMax-CD4 280 mg was administered as a subcutaneous (SC) infusion once daily (OD) up to 18 weeks. | Drug | HuMax-CD4 280 milligrams (mg) |
| HuMax-CD4Also: ZanolimumabHuMax-CD4 560 mg was administered as a SC infusion OD up to 18 weeks. | Drug | HuMax-CD4 560 mg |
Primary outcome
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
8 secondary outcomes
Number of Participants with Adverse Events (AEs)
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 at Weeks 2, 4 and 12
Time frame: At Weeks 2, 4 and 12
Percentage of Participants With Change from Baseline in Participant's Assessment of Pruritus Scale
Time frame: Baseline, up to Week 20
Time to Response
Time frame: From first dose to achieving a response (up to approximately 11 weeks)
Response Duration
Time frame: From achieving first response to last response/until relapse (up to approximately 92 weeks)
Time to Disease Progression
Time frame: From first dose until disease progressed (Up to 20 weeks)
Percentage of Participants with Change From Baseline in Total Body Surface Area (BSA)
Time frame: Baseline up to Week 20
Number of Participants With Positive Human Anti Human Antibodies (HAHA) Titres
Time frame: Up to Week 20
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing HuMax-CD4 in people with Cutaneous T-Cell Lymphoma, run by Genmab at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2023.