Evaluating the Effectiveness of Adding Rituximab to Standard Treatment for Thrombotic Thrombocytopenic Purpura (TTP) (STAR)
Thrombotic Thrombocytopenic Purpura
About this trial
This is an interventional treatment trial for Thrombotic Thrombocytopenic Purpura focused on measuring TTP, Rituximab, Plasma Exchange
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
- 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
- Known hypersensitivities or allergies to murine and/or humanized antibodies
- Currently participating in trials of investigational therapies or devices (other than investigational central catheters)
- Has ever had a diagnosis of ventricular tachycardia
- Acute transmural heart attack during the current hospital admission
Sites / Locations
- University of Alabama, Birmingham
- Emory University
- University of Iowa
- Tulane University Health Sciences Center
- University of Maryland Medical Center
- Johns Hopkins Hospital
- Massachusetts General Hospital
- Beth Israel Deaconess Medical Center
- Brigham and Women's Hospital
- Children's Hospital Boston
- New York-Presbyterian Hospital/Weill Cornell Medical Center
- University of North Carolina Hospitals
- Duke University Medical Center
- University Hospital Cleveland
- University of Oklahoma Health Sciences Center
- Integris Baptist Medical Center
- University of Pennsylvania
- Children's Hospital of Pittsburgh
- University of Pittsburgh Presbyterian and Shadyside Hospital
- Puget Sound Blood Center
- Gunderson Clinic, LTD
- University of Wisconsin at Madison
- Froedtert Memorial Lutheran Hospital
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
1
2
Participants will receive rituximab in addition to plasma exchange and corticosteroids.
Participants will receive plasma exchange and corticosteroids.