A PHASE 2, SINGLE ARM, MULTI-CENTER STUDY ON THE BENEFIT/COST/SAFETY PROFILE OF LOW-DOSE RITUXIMAB FOR REFRACTORY MIXED CRYOGLOBULINEMIA - ND
- Conditions
- Mixed cryoglobulinemia (type II or III) associated with chronic HCV infection (positive serology and/or HCV viremia)MedDRA version: 9.1Level: LLTClassification code 10011474Term: Cryoglobulinaemia
- Registration Number
- EUCTR2008-000086-38-IT
- Lead Sponsor
- AZIENDA UNIVERSITARIA POLICLINICO UMBERTO I DI ROMA
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- Not specified
A diagnosis of mixed cryoglobulinemia (type II or III) associated with chronic HCV infection (positive serology and/or HCV viremia). At least one of the following signs and symptoms of cryoglobulinemic vasculitis: - purpura - skin ulcer(s) - peripheral neuropathy (documented by ENG) - renal involvement (creatinine >2 mg/dl and increased BUN, and/or proteinuria >500 mg/day) - gastrointestinal involvement (vasculitis of the esophagus, stomach, small intestine, colon, or any intraabdominal viscera presenting as unexplained abdominal pain, gastrointestinal hemorrhage or intestinal ischemia) - signs & symptoms of hyperviscosity. - pulmonary involvement (pulmonary hemorrage caused by vasculitis) - severe CNS involvement (signs of active CNS vasculitis at MRI) Previous failure of anti-HCV therapy (PEG-IFN and ribavirine), relapse after response without indication to retreatment (according to the AIFA guidelines), contraindication or intolerance to anti-HCV therapy.
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
Previous treatment with rituximab Coexistence of life-threatening condition(s) unrelated to MC. A diagnosis of hematological or non-hematological malignancy. HIV or HBV positive Ongoing therapy with high dose corticosteroids and/or immunosuppressive drugs Ongoing plasmapheresis course (eligible 2 months after interruption) Any ongoing infection
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To assess the efficacy of rituximab at the reduced dosage of 250 mg/m2 x 2 for the treatment of HCV-associated MC;Secondary Objective: Correlation of B-cell depletion with clinical efficacy. Decrease of the requency of circulating B-cells with t(14;18)Bcl-2/IgH. Decrease of the frequency of monoclonal circulating B-cells.;Primary end point(s): Response rate at 12 weeks (BVAS < 50% baseline; cryocrit <50% baseline) Remission at 6 and 12 months (BVAS=0; cryocrit <20% baseline) Time to remission relapses during a 1-year follow up
- Secondary Outcome Measures
Name Time Method