A Phase 2 interventional study of rituximab in Thrombotic Thrombocytopenic Purpura, sponsored by Assistance Publique - Hôpitaux de Paris. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2014-02-27.
Sponsored by Assistance Publique - Hôpitaux de Paris · Phase 2, Interventional, and Treatment
Multicentric non-randomized phase II opened prospective study (10 centres involved).
Primary endpoint:
Secondary endpoints:
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.
263 studies on the registry are indexed under Purpura; 27 are open to participants now.
This study's enrollment of 12 is below the median of 50 across 171 interventional studies indexed under Purpura.
Browse Purpura studies →Assistance Publique - Hôpitaux de Paris is the lead sponsor of 3,504 studies on the registry; 1,006 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Microangiopathic hemolytic anemia (\< 12 g/dL) with thrombocytopenia (\<50 G/L)
Drug: rituximab
Patients will be treated according to the recommendations of the Reference Centre for the management of thrombotic microangiopathies. Infusions of rituximab (375 mg/m2) will be added to this treatment at day 1, 4 and 15, immediately after plasma exchange sessions.
To evaluate the kinetics of B-cell depletion by rituximab and its pharmacokinetics in patients treated with rituximab in association with plasma exchanges
Time frame: at 1, 3, 6, 9, 12, 18 and 24 months
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
Time frame: at 1, 3, 6, 9, 12, 18 and 24 months
To evaluate the incidence of persistent severe acquired ADAMTS13 deficiency following treatment with rituximab, as well as the incidence of relapses.
Time frame: at 1, 3, 6, 9, 12, 18 and 24 months
This study is completed, as verified in Feb 2014. You cannot join it, but the record below documents what was studied.
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Assistance Publique - Hôpitaux de Paris