An open-label, single-arm, phase II, prospective, pilot study of tocilizumab in patients with Erdheim-Chester disease.

OSPEDALE S. RAFFAELE DI MILANO0 sitesSeptember 21, 2012

Overview

No summary available.

Registry

who.int

Start Date

September 21, 2012

End Date

TBD

Last Updated

13 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

OSPEDALE S. RAFFAELE DI MILANO

•\-Patients aged \> \= 18 years able to understand and sign an informed consent\-\-diagnosis of ECD histologically documented ; \-advanced disease limited to the skeleton, with at least one measurable lesion; \-disease progression in the course of now most commonly used therapies (eg corticosteroids, interferon\-alpha, methotrexate) or a location (such as cardiac or CNS) known to be unresponsive to any of the treatments currently available; \-if women of childbearing age are necessary: a negative pregnancy test and the ability to exclude securely the beginning of a pregnancy for the duration of the study.
•Are the trial subjects under 18? no
•Number of subjects for this age range: 0
•F.1\.2 Adults (18\-64 years) yes
•F.1\.2\.1 Number of subjects for this age range 4
•F.1\.3 Elderly (\>\=65 years) yes
•F.1\.3\.1 Number of subjects for this age range 2

•\-history of hypersensitivity to tocilizumab or to any of the excipients;\-serious infections requiring hospitalization or antibiotic therapy within 30 days before enrollment in the study;\-active tuberculosis, listeriosis, histoplasmosis, sepsis, abscesses, opportunistic infections, active HBV or HCV\-previous history of tuberculosis (as documented by a positive PPD skin test and / or a positive QuantiFERON test and / or chest radiography), in the absence of documented and appropriate administration of a specific treatment for tuberculosis latent\-history of infection with HIV\-past history (\<5 years before enrollment) of a lymphoproliferative disorder or a solid tumor (excluding treated basal cell or squamous cell carcinoma of the skin);\-moderate or severe heart failure (class NYHAIII / IV), uncontrolled diabetes mellitus or other diseases that, in the opinion of the physician responsible for the protocol can be detrimental to the patient if he / she would enroll in the study, history of alcohol\-and / or drug abuse \- previous treatment with alkylating agents (chlorambucil, cyclophosphamide);\-serum creatinine\> 1\.6 mg / dL in women or\> 1\.9 mg / dl in male patients, AST and / or ALT \= 3 x ULN, platelets \<100\.000/fL; hemoglobin \<8\.5 g / dl, WBC \<1000 / fL; lymphocytes \<500/fL, total bilirubin\> 2\.0 mg / dL