Rituximab in Adult Acquired Idiopathic Thrombotic Thrombocytopenic Purpura

Sponsor
Assistance Publique - Hôpitaux de Paris
Study ID
NCT00907751
Phase
PHASE2
Status
Completed

Conditions

  • Thrombotic Thrombocytopenic Purpura

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • rituximab — DRUG
    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.

Study Details

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.

Key Dates

Start date
May 31, 2010
Status verified
Feb 2014
Primary completion
Aug 31, 2013
Completion
Aug 31, 2013

Study Design

Enrollment
12 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: 1
    Microangiopathic hemolytic anemia (\< 12 g/dL) with thrombocytopenia (\<50 G/L)

Primary Outcome Measure

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 ]

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