Rituximab in Patients With Relapsed or Refractory TTP-HUS
NCT ID: NCT00531089
Last Updated: 2010-05-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
60 participants
INTERVENTIONAL
2007-12-31
2011-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Study group
All patients in the study will be in the study group and will receive rituximab. There is no "control" arm.
Rituximab
Rituximab will be administered on weeks 1, 2, 3, and 4 at a dose of 375 mg/m2 per infusion. Premedications (prednisone 50 mg, diphenhydramine 50 mg, acetaminophen) will be administered prior to study infusion. Patients will also be treated with plasma exchange as per institution/apheresis centre.
Interventions
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Rituximab
Rituximab will be administered on weeks 1, 2, 3, and 4 at a dose of 375 mg/m2 per infusion. Premedications (prednisone 50 mg, diphenhydramine 50 mg, acetaminophen) will be administered prior to study infusion. Patients will also be treated with plasma exchange as per institution/apheresis centre.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* congenital or familial TTP
* TTP occuring post-stem cell, bone marrow, or solid organ transplant
* drug-induced TTP
* pregnancy or breast-feeding
* history of hepatitis B or C infection
* prior rituximab treatment
* active or metastatic cancer
* other causes of thrombocytopenia such as ITP, myelodysplastic syndrome, confirmed or suspected drug-induced thrombocytopenia
* refusal to receive blood products
* hypersensitivity to blood products, plasma products, murine proteins, or any component of the Rituximab formulation
* geographic inaccessibility
* co-morbid illness limiting life expectancy to less than 2 months independent of TTP
* failure to provide written informed consent
18 Years
ALL
No
Sponsors
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Canadian Apheresis Group
OTHER
Hoffmann-La Roche
INDUSTRY
McMaster University
OTHER
Hamilton Health Sciences Corporation
OTHER
Responsible Party
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Canadian Apheresis Group
Principal Investigators
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Kathryn E Webert, E
Role: PRINCIPAL_INVESTIGATOR
Hamilton Health Sciences Corporation
Ronan Foley, MD
Role: PRINCIPAL_INVESTIGATOR
Hamilton Health Sciences Corporation
Gail Rock, MD
Role: STUDY_DIRECTOR
Canadian Apheresis Group
William Clark, MD
Role: STUDY_DIRECTOR
University of Western Ontario/London Health Sciences
David Barth, MD
Role: STUDY_DIRECTOR
University of Toronto
Locations
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Foothills Medical Centre, Calgary Health REgion Apheresis Service
Calgary, Alberta, Canada
University of Alberta Hospital
Edmonton, Alberta, Canada
Vancouver General Hospital
Vancouver, British Columbia, Canada
Winnipeg Regional Health Authority, Apheresis Department
Winnipeg, Manitoba, Canada
St. John Regional Hospital
Saint John, New Brunswick, Canada
Hamilton Health Sciences
Hamilton, Ontario, Canada
London Health Sciences Centre, Westminister Campus
London, Ontario, Canada
Princess Margaret Hospital, ABMT/Apheresis Unit
Toronto, Ontario, Canada
Hopital Charles Lemoyne
Greenfield Park, Quebec, Canada
Hopital du Sacre-Coeur de Montreal
Montreal, Quebec, Canada
St. Paul's Hospital Apheresis Unit
Saskatoon, Saskatchewan, Canada
Countries
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Central Contacts
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Facility Contacts
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Sean Dolan, MD
Role: primary
S Fox, MD
Role: primary
Other Identifiers
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CAG-1
Identifier Type: -
Identifier Source: org_study_id
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