Mycosis FungoidesPhase 3NCT00127881
Study of Human Monoclonal Antibody to Treat Mycosis Fungoides and Sezary Syndrome
A Phase 3 study testing HuMax-CD4 (zanolimumab) in people with Mycosis Fungoides and Sezary Syndrome, run by Emergent Product Development Seattle LLC at 35 sites in 5 countries.
Trial summary
The purpose of this study is to determine the efficacy of the drug, HuMax-CD4, in patients with mycosis fungoides(MF) and sezary syndrome who are intolerant to or do not respond to treatment with Targretin® and one other standard therapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mycosis Fungoides, Sezary Syndrome
- What is being tested?
- HuMax-CD4 (zanolimumab)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- 35 sitesin 5 countries
- Study dates
- Jul 2005to Feb 2014
- Phase
- Phase 3
- 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
- A biopsy compatible with the diagnosis of MF and sezary syndrome with a CD4 positive phenotype within 6 months of study entry
- Refractory to or intolerant to at least two prior therapies, one being Targretin® (or combinations hereof).
- Signed informed consent
Who cannot join
- Prior treatment with Total Skin Electron Beam (TSEB) therapy within six months
- Prior treatment with Campath (alemtuzumab)
- Prior treatment with more than three regimens of single agent chemotherapy
- Prior treatment with pentostatin within 6 months
- Treatment within 4 weeks prior to visit 2 with topical Targretin®, skin directed therapies or systemic anticancer therapies, such as, but not limited to: Targretin® , UV-light therapy, local Electron Beam Therapy (EBT), extracorporal photo chemotherapy, methotrexate, bleomycin, cyclophosphamide, combination chemotherapy, oral retinoids, systemic glucocorticosteroids , carmustine, nitrogen mustard, systemic vitamin A or etretinate
- Treatment with topical glucocorticosteroids within 2 weeks prior to visit 2
Show all 15Show fewer
- Unwillingness or inability to avoid prolonged exposure to the sun or UV light sufficient to produce a mild erythema or thought by the investigator to likely modify the patient's disease
- Concurrent or previous malignancies within the past five years except adequately treated in situ carcinoma of the uterine cervix or basal or squamous cell skin carcinoma
- Significant concurrent, uncontrolled, or active medical condition including, but not limited to renal, hepatic, hematological, gastrointestinal, endocrine, pulmonary, cardiac, neurological, cerebral or psychiatric disease
- Known or suspected positive serology for HIV
- Known or suspected positive serology for hepatitis B or C
- Patients who are currently participating in any other trials or having received treatment with any experimental agent within 4 weeks prior to visit 1 (screening)
- Prior treatment with anti-CD4 monoclonal antibodies
- Breast feeding women or women with a positive pregnancy test at Visit 1
- Women of childbearing potential not willing to use either hormonal birth control, an intrauterine device or double-barrier method for the entire study period
Trial locations and contacts
35 sites in 5 countries.
35 sites in 5 countries
United States19 sites
University of Michigan Medical Center
Ann Arbor, Michigan, 48109
The Emory Clinic
Atlanta, Georgia, 30322
University of Colorado
Aurora, Colorado, 80045
University of Alabama at Birmingham
Birmingham, Alabama
Boston Medical Center
Boston, Massachusetts, 02118
Northwestern University
Chicago, Illinois, 60611
University Hospital of Cleveland
Cleveland, Ohio, 44106
Ohio State University
Columbus, Ohio, 43201
Duke University Medical Center
Durham, North Carolina, 27710
MD Anderson Cancer Center
Houston, Texas, 77030
Middle Tennessee Research Institute
Nashville, Tennessee, 37212-2637
Tulane University Health Science Center
New Orleans, Louisiana, 70112
New York Medical Center
New York, New York, 10016
Memorial Sloan Kettering
New York, New York, 10021
University of Pennsylvania Health System
Philadelphia, Pennsylvania, 19104
Oregon Health & Science University
Portland, Oregon, 97239
Stanford University Medical Center
Stanford, California, 94305
SUNY Upstate Medical University
Syracuse, New York, 13210
H. Lee Moffitt Cancer Center
Tampa, Florida, 33612
Germany5 sites
Skin Cancer Center Charite Mitte Dermatologie Fran Ramona Kursawa
Berlin, 10117
University of Essen - Universitatsklinikum Essen z. Hd. Frau Desire Zieling
Essen, 45122
University of kiel, Klinik Fur Dermotologie, Christian-Albrechts-Universitat Zu
Kiel, D-24105
Klinikum Minden / Hautklinik Minden
Minden, 32427
University of Wurzburg - Universitatsklinikum Wurzburg dermato-onkologische studien
Würzburg, 97080
Italy5 sites
Instituto di Ematologia e Oncologia Medica "L. & A. Seragnoli"
Bologna, 40138
Day Hospital Oncologico-Presidio Ospedaliero Firenze Centro Ospedale Santa Maria Nuova Azienda Sanitaria di Firenze, University of Florence
Florence, 50121
University of Milan-Fondazione IRCCS di Natura Pubblica Ospedale Maggiore Policlinico Mangiagalli e Regina Elena di Milano via Francesco Sforza
Milan, 20122
Instituto Dermopatico dell'Immacolata IRCCS via Monti di Creta
Roma, 00167
University of Turin SCDU Dermosifilopatia 2 A.S.O. Molinette S.Giovanni Battista
Turin, 10126
France4 sites
Hopital de I'Hotel-Dieu
Lyon, 69288
Consultation Dermatologie Niveau moins 1 Hopital Archet 2
Nice, 06220
Hopital Saint-Louis Service de Dermatologie
Paris, 75475
Centre Hospitalier Lyon Sud Bat. 1F 1er etage service Hematologie
Pierre-Bénite, 69495
Spain2 sites
Hospital Universitario de la Princesa
Madrid, 28006
Maternidad Planta Baja, Hospital 12 de Octubre
Madrid, 28041
About this study
Official title: Open Label, Dose Escalation, Followed by Open Label,Single Arm Clinical Trial of HuMax-CD4 in Patients With Mycosis Fungoides Type CTCL (Stage IB-IVB) or Sezary Syndrome Who Are Refractory or Intolerant to Targretin® (Bexarotene) and One Other Standard Therapy
The purpose of this study is to determine the efficacy of the drug, HuMax-CD4, in patients with mycosis fungoides(MF) and sezary syndrome who are intolerant to or do not respond to treatment with Targretin® and one other standard therapy.
- Conditions
- Mycosis Fungoides, Sezary Syndrome
- Being tested
- HuMax-CD4 (zanolimumab)
- Keywords
- Refractory or intolerant to Mycosis Fungoides and sezary syndrome, Cutaneous T-cell Lymphoma, To evaluate the efficacy and safety of zanolimumab in Mycosis Fungoides and sezary syndrome
- Medical subject headings
- Mycosis Fungoides, Sezary Syndrome, Lymphoma, T-Cell, Cutaneous
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HuMax-CD4 (zanolimumab)Drug
Monoclonal Antibody, 12 weekly infusions.
| Study group | Role | What they receive |
|---|---|---|
| Zanolimumab | Experimental | Not described Receives: Drug: HuMax-CD4 (zanolimumab) |
What is being measured
The primary outcome is the main question the study is designed to answer.
PGA Score
Measured: Duration of Study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2005 (estimated)
- Study startJul 2005
- Primary completionFeb 2014 (estimated)
Why it stopped: New sponsor, other treatments available
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mycosis FungoidesStudies of the same condition, open and under way.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emergent Product Development Seattle LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00127881
- Sponsor's protocol ID
- Hx-CD4-110
- Status last verified
- Jul 2012
- First submitted
- 8 Aug 2005
- Last updated
- 26 Jul 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open Label, Dose Escalation, Followed by Open Label,Single Arm Clinical Trial of HuMax-CD4 in Patients With Mycosis Fungoides Type CTCL (Stage IB-IVB) or Sezary Syndrome Who Are Refractory or Intolerant to Targretin® (Bexarotene) and One Other Standard Therapy
- ClinicalTrials.gov ID
- NCT00127881
- Acronym / sponsor ID
- Hx-CD4-110
- Conditions
- Mycosis Fungoides, Sezary Syndrome
- Keywords
- Refractory or intolerant to Mycosis Fungoides and sezary syndrome, Cutaneous T-cell Lymphoma, To evaluate the efficacy and safety of zanolimumab in Mycosis Fungoides and sezary syndrome
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: New sponsor, other treatments available
- Enrolment
- 76 participants (actual)
- Lead sponsor
- Emergent Product Development Seattle LLCIndustry (pharma, biotech, devices)
- Study start
- Jul 2005
- Primary completion
- Feb 2014 (estimated)
- First posted
- 9 Aug 2005 (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 study is to determine the efficacy of the drug, HuMax-CD4, in patients with mycosis fungoides(MF) and sezary syndrome who are intolerant to or do not respond to treatment with Targretin® and one other standard therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Zanolimumab | Experimental | Drug: HuMax-CD4 (zanolimumab) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- A biopsy compatible with the diagnosis of MF and sezary syndrome with a CD4 positive phenotype within 6 months of study entry
- Refractory to or intolerant to at least two prior therapies, one being Targretin® (or combinations hereof).
- Signed informed consent
Key exclusion criteria (15 listed)
- Prior treatment with Total Skin Electron Beam (TSEB) therapy within six months
- Prior treatment with Campath (alemtuzumab)
- Prior treatment with more than three regimens of single agent chemotherapy
- Prior treatment with pentostatin within 6 months
- Treatment within 4 weeks prior to visit 2 with topical Targretin®, skin directed therapies or systemic anticancer therapies, such as, but not limited to: Targretin® , UV-light therapy, local Electron Beam Therapy (EBT), extracorporal photo chemotherapy, methotrexate, bleomycin, cyclophosphamide, combination chemotherapy, oral retinoids, systemic glucocorticosteroids , carmustine, nitrogen mustard, systemic vitamin A or etretinate
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-CD4 (zanolimumab)Monoclonal Antibody, 12 weekly infusions. | Drug | Zanolimumab |
Primary outcome
PGA Score
Time frame: Duration of Study
Results and safety
The study was stopped early (reason given: New sponsor, other treatments available). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2012.
Related trials for Mycosis Fungoides
RecruitingObservational study
Blood, Urine, and Tissue Collection for Cutaneous Lymphoma, Eczema, and Atopic Dermatitis Research
Cutaneous T-cell Lymphoma, Sezary Syndrome
Active, not recruitingPhase 2
Dosing of Brentuximab Vedotin for Mycosis Fungoides, Sezary Syndrome Patients
Mycosis Fungoides, Lymphomatoid Papulosis
Not yet recruitingPhase 2
Golidocitinib in Patients With Mycosis Fungoides/Sézary Syndrome and T-Cell Large Granular Lymphocytic Leukemia
Mycosis Fungoides/Sezary Syndrome, T-cell Large Granular Lymphocytic Leukemia
RecruitingObservational study
A Prospective, US-based Study Assessing Mogamulizumab-associated Rash in Patients Diagnosed With Mycosis Fungoides or Sezary Syndrome and Treated With Standard of Care Mogamulizumab
Recurrent Mycosis Fungoides, Recurrent Sezary Syndrome
Active, not recruitingPhase 1
Duvelisib and Nivolumab for the Treatment of Stage IIB-IVB Mycosis Fungoides and Sezary Syndrome
Stage IIB Mycosis Fungoides and Sezary Syndrome AJCC v8, Stage III Mycosis Fungoides and Sezary Syndrome AJCC v8
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.
35 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing HuMax-CD4 (zanolimumab) in people with Mycosis Fungoides and Sezary Syndrome, run by Emergent Product Development Seattle LLC at 35 sites in 5 countries.
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 3 inclusion and 15 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: stopped early, as of the sponsor's last update on 26 Jul 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 35 sites in United States, Germany, Italy, France, Spain. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 was stopped early (reason given: New sponsor, other treatments available). Results are not available in the source record.
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?
PGA Score (time frame: Duration of Study). 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 26 Jul 2012.