Thrombotic Thrombocytopenic PurpuraPhase 3STARNCT00799773
Evaluating the Effectiveness of Adding Rituximab to Standard Treatment for Thrombotic Thrombocytopenic Purpura (TTP)
A Phase 3 study testing Rituximab, Plasma exchange and Corticosteroids in people with Thrombotic Thrombocytopenic Purpura, run by Carelon Research at 23 sites in United States.
Trial 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 transfusions of plasma, the liquid part of blood, from healthy donors. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Thrombotic Thrombocytopenic Purpura
- What is being tested?
- Rituximab, Plasma exchange and Corticosteroids
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 23 sitesUnited States
- Study dates
- Apr 2009to Feb 2010
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 29Show fewer
- 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
Trial locations and contacts
23 sites in 1 country.
23 sites in 1 country
United States23 sites
Emory University
Atlanta, Georgia, 30322
University of Maryland Medical Center
Baltimore, Maryland, 21201
Johns Hopkins Hospital
Baltimore, Maryland, 21205
University of Alabama, Birmingham
Birmingham, Alabama, 35249
Massachusetts General Hospital
Boston, Massachusetts, 02114
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02115
Brigham and Women's Hospital
Boston, Massachusetts, 02115
Children's Hospital Boston
Boston, Massachusetts, 02115
University of North Carolina Hospitals
Chapel Hill, North Carolina, 27514
University Hospital Cleveland
Cleveland, Ohio, 44106
Duke University Medical Center
Durham, North Carolina, 27710
University of Iowa
Iowa City, Iowa, 52242
Gunderson Clinic, LTD
La Crosse, Wisconsin, 54601
University of Wisconsin at Madison
Madison, Wisconsin, 53792
Froedtert Memorial Lutheran Hospital
Milwaukee, Wisconsin, 53226
Tulane University Health Sciences Center
New Orleans, Louisiana, 70112
New York-Presbyterian Hospital/Weill Cornell Medical Center
New York, New York, 10021
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73104
Integris Baptist Medical Center
Oklahoma City, Oklahoma, 73112
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, 15213
University of Pittsburgh Presbyterian and Shadyside Hospital
Pittsburgh, Pennsylvania, 15213
Puget Sound Blood Center
Seattle, Washington, 98104
About this study
Official title: STAR - Study of TTP and Rituximab, A Randomized Clinical Trial
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.
Read the 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 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.
- Conditions
- Thrombotic Thrombocytopenic Purpura
- Being tested
- Rituximab, Plasma exchange, Corticosteroids
- Keywords
- TTP, Rituximab, Plasma Exchange
- Medical subject headings
- Purpura, Thrombotic Thrombocytopenic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RituximabDrug
Also called Rituxan
Dose of 375 mg/m2, given intravenously, repeated at 1-week intervals for a total of four doses
Plasma exchangeProcedure or surgery
Target volume of 1.25 plasma volume replacement; fresh frozen plasma (FFP) is the required replacement fluid; provided daily until platelet counts are normal and signs of tissue damage have improved.
CorticosteroidsDrug
1 mg/kg of prednisone (or equivalent) each day until plasma exchange is stopped
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Participants will receive rituximab in addition to plasma exchange and corticosteroids. Receives: Drug: Rituximab; Procedure: Plasma exchange; Drug: Corticosteroids |
| 2 | Active comparator | Participants will receive plasma exchange and corticosteroids. Receives: Procedure: Plasma exchange; Drug: Corticosteroids |
What is being measured
The primary outcome is the main question the study is designed to answer.
Role of Rituximab in Increasing Early Treatment Response in Participants With TTP Who Are Also Treated With Plasma Exchange and Corticosteroids
Measured: Measured at Day 52
Secondary outcomes (11)
Use of Non-study Treatment
Measured: Measured at Month 36
Whether Participants Receiving Rituximab Achieve Early or Late Treatment Response Faster and Require Fewer Plasma Exchanges Than Participants Not Receiving Rituximab
Measured: Measured at Days 52 and 82
Relationship Between Clinical and Laboratory Data and Response to Treatment
Measured: Measured at Days 52 and 82
Incidence of Relapse Among Participants in the Two Study Groups Who Achieve Early Treatment Response
Measured: Measured at Month 36
All Cause Mortality
Measured: Measured at Month 36
Treatment-related Complications
Measured: Measured at Day 52
Evaluating How Levels of ADAMTS-13 Enzyme and Autoantibody at Specific Time Points or Over the Course of the Study Correlate With Other Indicators of Disease Activity, Remission Rates, Rapidity of Achieving a Remission, and Recurrence Rate
Measured: Measured at Month 36
Rituximab Response in Participants With Varying Levels of ADAMTS-13 Activity and Antibodies Against ADAMTS-13
Measured: Measured at Month 36
Effect of Plasma Exchange on Rituximab Levels
Measured: Measured at Month 6
Effect of Rituximab Levels on the Extent of B-cell Depletion (CD-19+ Cells)
Measured: Measured at Month 12
B-cell Depletion in Relation to ADAMTS-13 Activity and to ADAMTS-13 Antibody Levels and Disease Activity in Participants Who Receive Rituximab Versus Those Who do Not
Measured: Measured at Month 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2008 (estimated)
- Study startApr 2009
- Primary completionFeb 2010
- Study completionFeb 2010
Why it stopped: Low enrollment rate
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Thrombotic Thrombocytopenic PurpuraStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Carelon Research
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Susan F. Assmann, PhD, Principal investigator, New England Research Institutes, Inc.Jan McFarland, MD, Principal investigator, Froedtert HospitalEliot Williams, MD, PhD, Principal investigator, University of Wisconsin, MadisonKeith McCrae, MD, Principal investigator, University Hospitals Cleveland Medical CenterEllis Neufeld, MD, Principal investigator, Boston Children's HospitalJames Bussel, MD, Principal investigator, Weill Medical Colllege, Cornell UniversityThomas Ortel, MD, Principal investigator, Duke UniversityChristopher Hillyer, MD, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00799773
- Sponsor's protocol ID
- 558
- Other IDs
- U01HL072268, HL072268, HL072033, HL072291, HL072196, HL072248, HL072191, HL072305
- Acronym
- STAR
- Status last verified
- Jul 2013
- First submitted
- 26 Nov 2008
- Last updated
- 22 Jul 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- STAR - Study of TTP and Rituximab, A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT00799773
- Acronym / sponsor ID
- STAR / 558
- Conditions
- Thrombotic Thrombocytopenic Purpura
- Keywords
- TTP, Rituximab, Plasma Exchange
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Low enrollment rate
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Carelon ResearchUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI), Genentech, Inc.
- Study start
- Apr 2009
- Primary completion
- Feb 2010 (actual)
- Study completion
- Feb 2010 (actual)
- First posted
- 1 Dec 2008 (estimated)
- Results
- Posted 22 Jul 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Rituximab, Procedure: Plasma exchange, Drug: CorticosteroidsParticipants will receive rituximab in addition to plasma exchange and corticosteroids. |
| 2 | Active comparator | Procedure: Plasma exchange, Drug: CorticosteroidsParticipants will receive plasma exchange and corticosteroids. |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Differential or admission diagnosis of TTP-like syndrome, defined as the following:
- Receiving or will receive treatment for TTP with plasma exchange
- Has not started the sixth plasma exchange in the current TTP episode
Key exclusion criteria (29 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RituximabAlso: RituxanDose of 375 mg/m2, given intravenously, repeated at 1-week intervals for a total of four doses | Drug | 1 |
| Plasma exchangeTarget volume of 1.25 plasma volume replacement; fresh frozen plasma (FFP) is the required replacement fluid; provided daily until platelet counts are normal and signs of tissue damage have improved. | Procedure or surgery | 1, 2 |
| Corticosteroids1 mg/kg of prednisone (or equivalent) each day until plasma exchange is stopped | Drug | 1, 2 |
Primary outcome
Role of Rituximab in Increasing Early Treatment Response in Participants With TTP Who Are Also Treated With Plasma Exchange and Corticosteroids
Time frame: Measured at Day 52
11 secondary outcomes
Use of Non-study Treatment
Time frame: Measured at Month 36
Whether Participants Receiving Rituximab Achieve Early or Late Treatment Response Faster and Require Fewer Plasma Exchanges Than Participants Not Receiving Rituximab
Time frame: Measured at Days 52 and 82
Relationship Between Clinical and Laboratory Data and Response to Treatment
Time frame: Measured at Days 52 and 82
Incidence of Relapse Among Participants in the Two Study Groups Who Achieve Early Treatment Response
Time frame: Measured at Month 36
All Cause Mortality
Time frame: Measured at Month 36
Treatment-related Complications
Time frame: Measured at Day 52
Evaluating How Levels of ADAMTS-13 Enzyme and Autoantibody at Specific Time Points or Over the Course of the Study Correlate With Other Indicators of Disease Activity, Remission Rates, Rapidity of Achieving a Remission, and Recurrence Rate
Time frame: Measured at Month 36
Rituximab Response in Participants With Varying Levels of ADAMTS-13 Activity and Antibodies Against ADAMTS-13
Time frame: Measured at Month 36
Effect of Plasma Exchange on Rituximab Levels
Time frame: Measured at Month 6
Effect of Rituximab Levels on the Extent of B-cell Depletion (CD-19+ Cells)
Time frame: Measured at Month 12
B-cell Depletion in Relation to ADAMTS-13 Activity and to ADAMTS-13 Antibody Levels and Disease Activity in Participants Who Receive Rituximab Versus Those Who do Not
Time frame: Measured at Month 12
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Susan F. Assmann, PhD principal investigator
New England Research Institutes, Inc.
Jan McFarland, MD principal investigator
Froedtert Hospital
Eliot Williams, MD, PhD principal investigator
University of Wisconsin, Madison
23 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Rituximab, Plasma exchange and Corticosteroids in people with Thrombotic Thrombocytopenic Purpura, run by Carelon Research at 23 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 29 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 22 Jul 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 23 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 22 Jul 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Role of Rituximab in Increasing Early Treatment Response in Participants With TTP Who Are Also Treated With Plasma Exchange and Corticosteroids (time frame: Measured at Day 52). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2013.