EUCTR2006-003353-24-FR进行中（未招募）1 期
Open-label, Dose escalation, followed by Double-blind, Randomized, Two-dose, Parallel Group, Multi-center Clinical Trial of HuMax-CD4, a Fully Human Monoclonal Anti-CD4 Antibody, in Patients with Mycosis Fungoides type CTCL (stage IB-IVB) who are Refractory or Intolerant to Targretin® (bexarotene) and one other Standard Therapy - HuMax-CD4 in Refractory Mycosis Fungoides
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- Genmab A/S
- 入组人数
- 92
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1) A biopsy compatible with the diagnosis of MF with a CD4 positive phenotype within 6 months of study entry
- •2) MF stage IB to IVB (highest stage ever)
- •3) Refractory to or intolerant to at least two prior therapies, one being Targretin® (or combinations hereof), and the other being the current standard therapy at each institution. Stage 1 patients are only required to be refractory or intolerant to at least one prior current standard therapy
- •Refractory is defined as:
- •- resistance to therapy due to lack of response (defined as failure to obtain at least a 50% reduction in the disease for at least 6 months)
- •- progression of disease (defined as worsening of the disease by 25% or more compared to pre-treatment status) during therapy or within three months after cessation of therapy
- •Intolerance to prior therapy is defined as:
- •- Discontinuation of therapy due to side effects/toxicity of the therapy, whether or not response occurred. Side effects/toxicity of Targretin therapy which qualify for the intolerance criteria are isolated hypertriglyceridemia or combined hypertriglyceridemia/hypercholesterolemia despite dose reduction of Targretin and concomitant administration of anti-lipemic therapy, defined as:
- •a) Isolated hypertriglyceridemia defined as Triglycerides > 400 mg/d
- •b) Combined hypertriglyceridemia/hypercholesterolemia for non-diabetic patients Triglycerides > 200 mg/dL plus LDL cholesterol > 160 mg/dL or Triglycerides > 200 mg/dL plus HDL cholesterol < 40 mg/dL
- •c) Combined hypertriglyceridemia/hypercholesterolemia in diabetic patients (type I and II): Triglycerides > 150 mg/dL plus LDL cholesterol > 130 mg/dL or Triglycerides > 150 mg/dL plus HDL cholesterol < 40 mg/dL
- •- Other side effects/toxicities of Targretin, despite dose reduction, which qualify for the intolerance criteria:
- •d) ALT > 3 times upper limit of normal
- •e) AST > 3 times upper limit of normal
- •f) Bilirubin > 3 times upper limit of normal
- •g) NCI grade 3 leucopenia
- •h) Uncorrectable hypothyroidism
- •i) Drug related dermatitis
- •Ineligibility (as part of the intolerance criteria) to treatment with Targretin® despite administration of anti-lipemic therapy or due to concurrent medical conditions, such as:
- •- Isolated hypertriglyceridemia or combined hypertriglyceridemia/
- •hypercholesterolemia, defined as:
- •a) Isolated hypertriglyceridemia defined as Triglycerides > 400 mg/dL
- •b) Combined hypertriglyceridemia/hypercholesterolemia in non-diabetic patients defined as Triglycerides > 200 mg/dL plus LDL cholesterol > 160 mg/dL or Triglycerides > 200 mg/dL plus HDL cholesterol < 40 mg/dL
- •c) Combined hypertriglyceridemia/hypercholesterolemia in diabetic patients (Type I and II): Triglycerides > 150 mg/dL plus LDL cholesterol > 130 mg/dL or Triglycerides > 150 mg/dL plus HDL cholesterol < 40 mg/dL
- •- Prior pancreatitis
- •- Recurrent biliary colic
- •- Known hypersensitivity to retinoids
- •- Incapability to swallow Targretin capsules
- •4. WHO performance status 0, 1 or 2
- •5. Age = 18 years
- •6. Following receipt of verbal and written information about the study, the patient must provide signed consent before any study related activity is carried out
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Sezary syndrome
- •2. Primary cutaneous anaplastic large cell lymphoma
- •3. Lymphomatoid papulosis
- •4. Histopathological evidence of sheets of large cells (from skin or nodes) or poorly differentiated tumors
- •5. Prior treatment with combination chemotherapy within six months
- •6. Prior treatment with Total Skin Electron Beam (TSEB) therapy within one year
- •7. Prior treatment with Campath (alemtuzumab)
- •8. Prior treatment with more than three regimens of single agent chemotherapy
- •9. Prior treatment with pentostatin within two years
- •10. 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, oral retinoids, systemic glucocorticosteroids, carmustine, nitrogen mustard, systemic vitamin A or etretinate
- •11. Treatment with topical glucocorticosteroids within 2 weeks prior to visit 2
- •12. 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
- •13. 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
- •14. Acute or chronic infectious disease (including herpes simplex and herpes zoster) requiring medication except patients taking dicloxillin for carriage of staphylococcus
- •15. Significant concurrent, uncontrolled, or active medical condition including, but not limited to renal, hepatic, hematological, gastrointestinal, endocrine, pulmonary, cardiac, neurological, cerebral or psychiatric disease
- •16. Screening blood laboratory values:
- •a) Hemoglobin < 8.5 g/dL
- •b) WBC = 2.5 x 10^9 cells/L
- •c) Platelets < 100 x 10^9 cells/L
- •d) ALT/AST > 2.5 times upper limit of normal
- •e) S-Creatinine > 1.5 mg/dL
- •f) CD3+ CD4+ cell count > 2000 cells/mm^3
- •g) CD4/CD8 ratio of 10 or higher
- •h) CD4+ CD7– cells = 40% of CD4+ cells
- •i) CD4+ CD26– cells = 40% of CD4+ cells
- •17. Known or suspected positive serology for HIV
- •18. Known or suspected positive serology for hepatitis B or C
- •19. Signs or symptoms of CNS involvement
- •20. 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)
- •21. Prior treatment with anti-CD4 monoclonal antibodies
- •22. Patients known or suspected of not being able to comply with a study protocol (e.g. due to alcoholism, drug dependency or psychological disorder)
- •23. Breast feeding women or women with a positive pregnancy test at Visit 1
- •24. Women of childbearing potential not willing to use either hormonal birth control, an intrauterine device or double-barrier method for the entire study period
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