Mixed cryoglobulinemia (type II or III) associated with chronic HCV infection (positive serology and/or HCV viremia) MedDRA version: 9.1 Level: LLT Classification code 10011474 Term: Cryoglobulinaemia
Conditions
Sponsors
AZIENDA UNIVERSITARIA POLICLINICO UMBERTO I DI ROMA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Italy
Outcome results
None listed