The cutaneous T-cell lymphoma (also known as Sézary syndrome) is a common disorder of proliferated cells with characteristics of maligne t-lymphocytes immigrating from the cutaneous blood vessels to dermis and epidermis. Efalizumab inhibits extravasation of t-lymphocytes to dermis and inhibits epidermal stimulation by their interaction with the Langerhans-cells.
Conditions
Interventions
Trade Name: Raptiva®100 mg/ml
Product Name: Efalizumab
Pharmaceutical Form: Powder for solution for injection
Sponsors
Charité - University Hospital Berlin
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - written informed consent - age min. 18 years - patients with Sézary syndrome evaluated by skin biopsy - patients with at minimum one systemic therapy. systemic therapies are PUVA, photophoresis. chemotherapy e.g. methotrexat, and IFN-alpha - patients complying the following laboratory parameters: *leukocytes >= 1,5x10^9/L *hemoglobin >= 9 g/dL *thrombocytes >= 100x10^9/L *potassium >= lower limit of normal *total calcium (corrected for serum albumin) or iionised calcium >= lower limit of normal *magnesium >= lower limit of normal *AST/SGOT and ALT/SGPT = 50mL/min - World Health Organization (WHO) performance status =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - notification of sepsis, current tuberculosis or another serious infection disease - general appearance including CNS - cardiac or renal insufficiency - concurrent chemotherapy or radiotherapy including whole body irradiation and phototherapy (PUVA, UVA, UVB, UVB 311nm) - treatment with chemotherapy or investigational drug or major surgery within 4 weeks before study enrolment or patients - pregnant or nursing patients - female patients of childbearing potential or male patients and their partners without highly effective contraception (PEARL-Index < 1%, e.g., hormonal contraception, intrauterine device, condom with spermicide, etc.) during and for 6 months after discontinuation of study treatment - diagnosis of another cancer within 5 years before study enrolment except of a curatively treated Melanoma-in-situ or basal cell carcinoma or squamous epithelium carcinoma of the skin - patients with HIV - patients who are detained officially or legally to an official institute - lack of compliance - all contraindications against investigational product esp. hypersensitivity against Efalizumab or pharmaceutical additives as formation - lack of willingness to save and provide pseudonymised data within the clinical trial - specific forms of psoriasis
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: - Response rate evaluated by Severity-Weighted Assessment Tool (SWAT);Secondary Objective: - Response rate evaluated by Physicians Global Assessment of Clinical Condition (PGA) - Documentation of symptoms and patient recruitment - Evalution and foto documentation of response of index lesions - Duration of response - Duration until response - Progression free survival rate - Pharmacocinetics of Efalizumab - Analysis of biological marker (histology, t-cell receptor-beta PCR, PCR, flow cytometry and evaluation of cytokines IL-12 and IFN-gamma);Primary end point(s): | — |
Countries
Germany
Outcome results
None listed