Thrombotic Thrombocytopenic Purpura Clinical Trial
Official title:
Association of Rituximab to Plasma Exchange in Adult Acquired Idiopathic Thrombotic Thrombocytopenic Purpura
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.
Duration of the study:
3 years and 2 months, including 1 year of inclusion and 2 years of participation for the
patient.
Experimental plan:
Patients fulfilling the inclusion criteria of the study will be treated according to the
recommendations of the Reference Centre for the management of thrombotic microangiopathies.
If patients present refractory TTP, infusions of rituximab (375 mg/m2) will be added to this
treatment at day 1, 4 and 15, immediately after plasma exchange sessions.On diagnosis,
during treatment and after remission achievement, the following values will be explored:
ADAMTS13 activity, ADAMTS13 inhibitors and anti-ADAMTS13 antibodies, B-cell lymphocytes
quantification by immunophenotyping, and serum gammaglobulin level by serum protein
electrophoresis. Rituximab will also be quantified.
Number of patients:
Each participating centre may recruit and include 1 patient/year.Amongst 10 participating
centres, a total number of 10 patients should be included.
Specific activities during the study:
Three infusions of rituximab (375 mg/m2 /infusion), immediately after plasma exchange
sessions on day 1, 4 and 15. Blood samplings at day 1, 4 and 15, at 1 month and then every 3
month until month 24.
Expected results and perspectives:
This study should provide evidence as to whether the association of rituximab to plasma
exchanges allo an efficient B-cell depletion. If yes, a randomized study should be performed
to evaluate the role of rituximab at the acute phase of acquired idiopathic TTP, immediately
after the diagnosis was established.
;
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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