STAR - Study of TTP and Rituximab, A Randomized Clinical Trial
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 the brain, kidneys, and heart. This can lead to neurological problems,
stroke, abnormal kidney function, and heart problems. Because a large number of platelets
are used in the blood clotting process, people with TTP have a reduced number of platelets
circulating in their blood. They also have fewer red blood cells circulating in their blood
because the red blood cells break down prematurely as blood squeezes past a blood clot.
The primary treatment for TTP is plasmapheresis, also called plasma exchange, which is a
procedure that circulates a person's blood through a machine that first removes the damaged
plasma and then adds healthy donor plasma into the blood. Next, patients receive a blood
transfusion with the new blood. Corticosteroids, a type of medication that reduces the
amount of antibodies a person's body makes, are also commonly used in conjunction with
plasma exchange to treat TTP. Plasma exchange is usually effective, with platelet and red
blood cell counts returning to normal after the procedure is complete. However, some people
do experience a relapse of TTP and will require repeat plasma exchanges. Rituximab, an
antibody currently used to treat lymphoma and rheumatoid arthritis, may improve immune
system response and decrease the number of days needed to undergo the plasma exchange
procedure. The purpose of this study is to evaluate the effectiveness of rituximab in
combination with plasma exchange at improving an early treatment response in people with TTP
and decreasing the likelihood of a relapse of TTP.
This 3-year study will enroll people who have recently been diagnosed with TTP or recently
experienced a relapse and have not yet had six plasma exchanges during the current episode
of TTP. Participants will be randomly assigned to receive either plasma exchanges and
corticosteroids or plasma exchanges, corticosteroids, and rituximab. Blood will be collected
from participants at baseline and each day they undergo the plasma exchange procedure. All
participants will receive a plasma exchange every day until their platelet counts are normal
and signs of tissue damage have improved. Participants will receive corticosteroid
medication every day until plasma exchange is stopped, at which time the dosage will be
gradually tapered until 7 weeks after the last plasma exchange. Participants receiving
rituximab will receive the first dose intravenously within 7 days of the first plasma
exchange; they will continue to receive rituximab once a week for 4 weeks. After the plasma
exchanges are completed, all participants will have routine follow-up care with their
doctors to make sure there is no TTP relapse. In the 1 year after study entry, additional
blood collections will occur at varying times. Study researchers will monitor participants'
health in the 3 years after study entry by following up with their doctors or through
periodic phone calls. A portion of blood will be collected and stored for future TTP
research purposes; this is optional.
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Role of rituximab in increasing early treatment response in participants with TTP who are also treated with plasma exchange and corticosteroids
Measured at Day 52
No
Susan F. Assmann, PhD
Principal Investigator
New England Research Institutes, Inc.
United States: Food and Drug Administration
558
NCT00799773
April 2009
February 2010
Name | Location |
---|---|
University of Iowa | Iowa City, Iowa 52242 |
Beth Israel Deaconess Medical Center | Boston, Massachusetts 02215 |
Children's Hospital of Pittsburgh | Pittsburgh, Pennsylvania 15213 |
University of Oklahoma Health Sciences Center | Oklahoma City, Oklahoma 73104 |
Brigham and Women's Hospital | Boston, Massachusetts 02115 |
Massachusetts General Hospital | Boston, Massachusetts 02114-2617 |
Froedtert Memorial Lutheran Hospital | Milwaukee, Wisconsin 53226 |
Children's Hospital Boston | Boston, Massachusetts 02115 |
University of Pennsylvania | Philadelphia, Pennsylvania 19104 |
Duke University Medical Center | Durham, North Carolina 27710 |
Emory University | Atlanta, Georgia 30322 |
University of Alabama, Birmingham | Birmingham, Alabama 35233 |
Tulane University Health Sciences Center | New Orleans, Louisiana 70112 |
University of North Carolina Hospitals | Chapel Hill, North Carolina 27599 |
University of Maryland Medical Center | Baltimore, Maryland 21201-1595 |
Integris Baptist Medical Center | Oklahoma City, Oklahoma 73112 |
Johns Hopkins Hospital | Baltimore, Maryland 21287 |
Gunderson Clinic, Ltd | La Crosse, Wisconsin 54601 |
Puget Sound Blood Center | Seattle, Washington 98014 |
University of Wisconsin at Madison | Madison, Wisconsin 53792 |
New York-Presbyterian Hospital/Weill Cornell Medical Center | New York, New York 10021 |
University Hospital Cleveland | Cleveland, Ohio 44106 |
University of Pittsburgh Presbyterian and Shadyside Hospital | Pittsburgh, Pennsylvania 15213 |