Low Dose Rituximab in Thrombotic Thrombocytopenic Purpura
United States19 participantsStarted 2012-08
Plain-language summary
Thrombotic thrombocytopenic purpura (TTP) is a disease characterized by small blood clots throughout the body that can damage major organs and cause death. TTP is treated with plasma exchange (also called "plasmapheresis"). Patients who do not respond initially to plasma exchange often are helped by later treatment with rituximab. The purpose of this study is to see whether combining low doses of rituximab with plasma exchange will help patients get better sooner and reduce the chance of getting TTP again.
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
✓. Age 18 or greater
✓. Diagnosis of suspected thrombotic thrombocytopenic purpura (TTP)
✓. Platelet count of \< 80,000 for newly diagnosed patients and \< 120,000 for relapsed patients
✓. Microangiopathic hemolytic anemia with RBC fragmentation
✓. LDH \>1 x ULN
✓. Subjects who will receive treatment for TTP with plasma exchange
✓. Subjects who have not started the 5th plasma exchange
✓. Plasma ADAMTS13 activity \<10%
Exclusion criteria
✕. Treatment for TTP within the past 2 months
✕. Severe active infection indicated by sepsis (requirement for pressors with or without positive blood cultures) or clinical evidence of enteric infection with E. coli O157:H7 or related organism
✕. Currently under treatment for cancer (subjects with localized skin carcinoma will be accepted)
✕. Microangiopathic hemolytic anemia due to a mechanical heart valve
✕. Severe hypertension, as defined by systolic BP \>180 AND diastolic BP \>120, or papilledema
✕
What they're measuring
1
Incidence of the Composite Primary Outcome of Exacerbation or Refractory TTP