Low Dose Rituximab in Thrombotic Thrombocytopenic Purpura

Completed · Phase 2

Conditions studied: Thrombotic Thrombocytopenic Purpura

In brief

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.

Key facts

Study ID

NCT01554514

Run by

Washington University School of Medicine

People needed

19

Starts

2012-08-01

Expected to finish

2020-02-14

Last updated by the study team

2021-08-17

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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%

You may not qualify if…

• 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
• Organ or stem cell transplant
• Use of calcineurin inhibitors (sirolimus, tacrolimus, cyclosporin A) within 6 months prior to diagnosis of TTP
• Disseminated intravascular coagulation as defined by:
• a. INR >2.0 (unrelated to anticoagulation, unresponsive to Vitamin K) or b. Fibrinogen <100 mg/dl
• Pregnancy
• Known congenital TTP.
• Rituximab within the previous year.
• HIV history or positive serology
• History of hepatitis B or positive serology for HBsAg or Anti-HBc
• Persistent or unexplained platelet count below 150,000/μL within 3 months of current TTP presentation
• Hypersensitivities or allergies to murine and/or humanized antibodies
• Current participation in trials of investigational therapies or devices, other than central catheters

Where it is running

• Emory University — Atlanta, Georgia, United States
• Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States
• Washington University — St Louis, Missouri, United States
• Duke University Medical Center — Durham, North Carolina, United States

Full record on ClinicalTrials.gov

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