Study of Human Monoclonal Antibody to Treat Mycosis Fungoides and Sezary Syndrome

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

Status

Terminated

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00127881

Enrollment

Registered

2005-08-09

Start date

2005-07-31

Completion date

Unknown

Last updated

2012-07-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

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

Brief 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.

Interventions

DRUGHuMax-CD4 (zanolimumab)

Monoclonal Antibody, 12 weekly infusions.

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* 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

Exclusion criteria

* 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 * 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

Design outcomes

Primary

Measure	Time frame
PGA Score	Duration of Study

Countries

France, Germany, Italy, Spain, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026