Rituximab in Adult Acquired Idiopathic Thrombotic Thrombocytopenic Purpura

• Status: Completed
• Trial end date: 2013-08-01
• Target enrollment: 0
• Participant gender: All

Summary

Multicentric non-randomized phase II opened prospective study (10 centres involved).

Primary endpoint:

• To evaluate the kinetics of B-cell depletion by rituximab and its pharmacokinetics in patients treated with rituximab in association with plasma exchanges.

Secondary endpoints:

• To evaluate the tolerance of rituximab, the volume of plasma and the number of plasma exchange sessions required to achieve a durable complete remission, and to determinate the duration of B-cell depletion.

• To evaluate the incidence of persistent severe acquired ADAMTS13 deficiency following treatment with rituximab, as well as the incidence of relapses.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Assistance Publique - Hôpitaux de Paris
• Treatments: Rituximab

Criteria

Inclusion Criteria:

• Microangiopathic hemolytic anemia (< 12 g/dL) with thrombocytopenia <50 G/L, and mild or no renal failure (Serum creatinine < 150 µmol/L),

• negative Beta HCG and ongoing contraception during treatment and during the 24 months following the last infusion of rituximab,

• refractory TTP (after 4 days of standard treatment)

• > 18 year old

• and signed written informed consent.

Exclusion Criteria:

• Hemolytic uremic syndrome (platelet count ³ 50 G/L and serum creatinine ³ 150 micromol/L),

• TTP associated with another condition (HIV infection, cancer and/or chemotherapy, transplantation),

• previous treatment with vincristine or cyclophosphamide or other immunomodulatory drugs (except steroids), within 2 months before inclusion ;

• ongoing or planned pregnancy, lactation