CompletedPhase 2

Rituximab in Adult Acquired Idiopathic Thrombotic Thrombocytopenic Purpura

France12 participantsStarted 2010-05

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

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

Timeframe: at 1, 3, 6, 9, 12, 18 and 24 months

Trial details

NCT IDNCT00907751

SponsorAssistance Publique - Hôpitaux de Paris

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2013-08