Rituximab in Adult Acquired Idiopathic Thrombotic Thrombocytopenic Purpura

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.

Timeline

Start

2010-05

Primary completion

2013-08

Completion

2013-08

Publications

• Benhamou Y, Paintaud G, Azoulay E, Poullin P, Galicier L, Desvignes C, Baudel JL, Peltier J, Mira JP, Pene F, Presne C, Saheb S, Deligny C, Rousseau A, Feger F, Veyradier A, Coppo P; French Reference Center for Thrombotic Microangiopathies. Efficacy of a rituximab regimen based on B cell depletion in thrombotic thrombocytopenic purpura with suboptimal response to standard treatment: Results of a phase II, multicenter noncomparative study. Am J Hematol. 2016 Dec;91(12):1246-1251. doi: 10.1002/ajh.24559. Epub 2016 Nov 8.

Drugs

Indications