Evaluating the Effectiveness of Adding Rituximab to Standard Treatment for Thrombotic Thrombocytopenic Purpura (TTP)

Stopped early · Phase 3

Conditions studied: Thrombotic Thrombocytopenic Purpura

In brief

Thrombotic thrombocytopenic purpura (TTP) is a rare disorder that causes blood clots to form in blood vessels. The main treatment for TTP is plasma exchange, in which affected patients receive transfusions of plasma, the liquid part of blood, from healthy donors. This study will examine the effectiveness of an antibody, rituximab, in combination with plasma exchange, at improving the immune response in people with TTP and decreasing the recurrence of TTP.

Key facts

Study ID

NCT00799773

Run by

Carelon Research

People needed

3

Starts

2009-04-01

Expected to finish

2010-02-01

Last updated by the study team

2013-07-22

Who can join

Age: 12 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Differential or admission diagnosis of TTP-like syndrome, defined as the following:
• Platelet count of less than 80,000/µL for newly diagnosed patients and less than 120,000/µL for relapsed patients
• Microangiopathic hemolytic anemia (MHA) with red blood cell fragmentation
• Lactate dehydrogenase (LDH) level greater than two times the upper limit of normal for newly diagnosed patients and greater than the upper limit of normal for relapsed patients
• Receiving or will receive treatment for TTP with plasma exchange
• Has not started the sixth plasma exchange in the current TTP episode

You may not qualify if…

• Treated for TTP in the 2 months before study entry
• Previously enrolled in this study
• Severe active infection indicated by sepsis (requirement for pressors with or without positive blood cultures) or clinical evidence of enteric infection with E. coli 0157 or related organism
• Currently under treatment for cancer or has a current diagnosis of cancer (other than localized skin carcinoma)
• Microangiopathic hemolytic anemia due to a mechanical heart valve
• Severe high blood pressure, as defined by systolic blood pressure of greater than 180 and diastolic blood pressure of greater than 120, or papilledema
• Has ever had an organ or stem cell transplant
• Has received calcineurin inhibitors (e.g., sirolimus, tacrolimus, cyclosporin A) in the 6 months before TTP diagnosis
• Diagnosis of disseminated intravascular coagulation (DIC), defined as the following:
• International normalized ratio (INR) level greater than 2.0 (unrelated to anticoagulation, unresponsive to vitamin K administration) OR
• Fibrinogen less than 100 mg/dL
• Pregnant
• Requires ventilator assistance or intravenous pressors for treatment of TTP. If no longer required prior to study entry, patient is eligible for the study.
• Known congenital TTP or family history of TTP
• Established diagnosis of lupus, and/or actively treated for lupus in the 60 days before study entry. In addition, people with two or more of the following systemic lupus erythematosus (SLE) clinical criteria in the 60 days before study entry will be excluded:
• Characteristic skin rash, either malar or photosensitive
• Symmetric polyarthritis
• Serositis, either pleurisy or pericarditis
• Previously received rituximab
• Has taken the following drugs known to be associated with TTP-like syndrome in the 3 months before study entry: clopidogrel (Plavix), ticlopidine (Ticlid), or quinine
• Will receive more than 1.5 plasma volumes per day after study entry
• HIV history or positive serology
• History of hepatitis B or positive serology for HBsAg or Anti-hepatitis B core antigen (Anti-HBc)
• History of hepatitis C
• Known persistent or unexplained platelet count below 150,000/µL in the 3 months before current TTP episode

Where it is running

• University of Alabama, Birmingham — Birmingham, Alabama, United States
• Emory University — Atlanta, Georgia, United States
• University of Iowa — Iowa City, Iowa, United States
• Tulane University Health Sciences Center — New Orleans, Louisiana, United States
• University of Maryland Medical Center — Baltimore, Maryland, United States
• Johns Hopkins Hospital — Baltimore, Maryland, United States
• Massachusetts General Hospital — Boston, Massachusetts, United States
• Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States
• Brigham and Women's Hospital — Boston, Massachusetts, United States
• Children's Hospital Boston — Boston, Massachusetts, United States
• New York-Presbyterian Hospital/Weill Cornell Medical Center — New York, New York, United States
• University of North Carolina Hospitals — Chapel Hill, North Carolina, United States
• Duke University Medical Center — Durham, North Carolina, United States
• University Hospital Cleveland — Cleveland, Ohio, United States
• University of Oklahoma Health Sciences Center — Oklahoma City, Oklahoma, United States
• Integris Baptist Medical Center — Oklahoma City, Oklahoma, United States
• University of Pennsylvania — Philadelphia, Pennsylvania, United States
• Children's Hospital of Pittsburgh — Pittsburgh, Pennsylvania, United States
• University of Pittsburgh Presbyterian and Shadyside Hospital — Pittsburgh, Pennsylvania, United States
• Puget Sound Blood Center — Seattle, Washington, United States
• Gunderson Clinic, LTD — La Crosse, Wisconsin, United States
• University of Wisconsin at Madison — Madison, Wisconsin, United States
• Froedtert Memorial Lutheran Hospital — Milwaukee, Wisconsin, United States

Full record on ClinicalTrials.gov

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