Status:
TERMINATED
Evaluating the Effectiveness of Adding Rituximab to Standard Treatment for Thrombotic Thrombocytopenic Purpura (TTP)
Lead Sponsor:
Carelon Research
Collaborating Sponsors:
National Heart, Lung, and Blood Institute (NHLBI)
Genentech, Inc.
Conditions:
Thrombotic Thrombocytopenic Purpura
Eligibility:
All Genders
12+ years
Phase:
PHASE3
Brief Summary
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 transfu...
Detailed Description
TTP is a disorder that causes blood clots to form in the small blood vessels throughout the body. If the clots in fact block the blood vessels, blood flow is restricted to various organs, including th...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2010
Estimated Enrollment :
3 Patients enrolled
Trial Details
Trial ID
NCT00799773
Start Date
April 1 2009
End Date
February 1 2010
Last Update
July 22 2013
Active Locations (23)
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1
University of Alabama, Birmingham
Birmingham, Alabama, United States, 35249
2
Emory University
Atlanta, Georgia, United States, 30322
3
University of Iowa
Iowa City, Iowa, United States, 52242
4
Tulane University Health Sciences Center
New Orleans, Louisiana, United States, 70112