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Rituximab in Patients With Relapsed or Refractory TTP-HUS

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00531089
Recruitment Status : Unknown
Verified September 2007 by McMaster University.
Recruitment status was:  Recruiting
First Posted : September 18, 2007
Last Update Posted : May 19, 2010
Sponsor:
Collaborators:
Canadian Apheresis Group
Hoffmann-La Roche
McMaster University
Information provided by:
McMaster University

Study Description
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Brief Summary:
The general objective of this study is to assess the efficacy and safety of Rituximab in the management of patients with refractory or relapsed thrombotic thrombocytopenic purpura-hemolytic uremic syndrome (TTP-HUS). There have been several case reports and case series describing the use of Rituximab in patients with TTP-HUS; however its use has not been studied in a large trial. It is hypothesized that Rituximab may ameliorate the severity of certain cases of TTP-HUS by decreasing the number of activity of B-cells which may result in decreased production of the ADAMTS13 protease inhibitor. Patients with TTP-HUS not responding to standard therapy or patients with relapsed disease may have particular benefit. Treatments that decrease the frequency of relapse or shorten the time to remission of TTP-HUS will be of benefit by decreasing the need for blood product support.

Condition or disease Intervention/treatment Phase
Thrombotic Thrombocytopenic Purpura Hemolytic Uremic Syndrome Drug: Rituximab Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Study Evaluating the Efficacy of Rituximab in the Management of Patients With Relapsed/Refractory Thrombotic Thrombocytopenic Purpura (TTP) - Hemolytic Uremic Syndrome (HUS)
Study Start Date : December 2007
Estimated Primary Completion Date : January 2011
Estimated Study Completion Date : January 2011

Resource links provided by the National Library of Medicine

Drug Information available for: Rituximab

Arms and Interventions
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Arm Intervention/treatment
Experimental: Study group
All patients in the study will be in the study group and will receive rituximab. There is no "control" arm.
 Drug: 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 Name: Rituxan, rituximab


Outcome Measures
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Primary Outcome Measures :
  1. The proportion of patients achieving all: (1) platelet count >150x109/L; (2) LDH < 1.5 x normal; (3) no requirement for plasma exchange therapy; (4) asymptomatic. [ Time Frame: 8 weeks after initiation of therapy ]

Secondary Outcome Measures :
  1. proportion of patients with platelet count greater than 150 x 109/L [ Time Frame: 8 weeks ]
  2. proportion of patients with LDH < 1.5 X normal [ Time Frame: 8 weeks ]
  3. proportion of patients with no requirement for plasma exchange therapy [ Time Frame: 8 weeks ]
  4. proportion of patients who are asymptomatic (no new neurological symptoms ans stabilization of previous neurological symptoms [ Time Frame: 8 weeks ]
  5. clinical response (CR, PR, non-response) [ Time Frame: 52 weeks ]
  6. frequency of relapse [ Time Frame: 52 weeks ]
  7. mortality [ Time Frame: 52 weeks ]
  8. changes from baseline in platelet counts, LDH, ADAMTS13 protease level, ADAMTS13 inhibitor level [ Time Frame: 8, 12, 24, 52 weeks ]
  9. toxicity and clinical safety as assessed by monitoring of adverse events, laboratory parameters, vital signs during infusion, and immediate tolerability [ Time Frame: 8 weeks ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • any patient 18 years or older diagnosed with relapsed or refractory TTP-HUS requiring therapy

Exclusion Criteria:

  • alternate cause of hemolytic microangiopathy (evidence of DIC, malignant hypertension, vasculitis, anti-phospholipid antibody syndrome, post-partum acute renal failure)
  • 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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00531089


Contacts
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Contact: Kathryn E Webert, MD 905-521-2100 ext 76733 webertk@mcmaster.ca

Locations
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Canada, Alberta
Foothills Medical Centre, Calgary Health REgion Apheresis Service Not yet recruiting
Calgary, Alberta, Canada, T2N 2T9
Contact: John Klassen, MD    403-944-4712    john.klassen@calgaryhealthregion.ca   
Principal Investigator: John Klassen, MD         
University of Alberta Hospital Not yet recruiting
Edmonton, Alberta, Canada
Principal Investigator: L Larratt, MD         
Canada, British Columbia
Vancouver General Hospital Recruiting
Vancouver, British Columbia, Canada, V5Z1M9
Contact: Paul Yenson, Dr.    604-875-4863    pyenson@bccancer.bc.ca   
Contact: Lisa Basque    604-875-4111 ext 69014    lbasque@bccancer.bc.ca   
Principal Investigator: Paul Yenson, Dr         
Canada, Manitoba
Winnipeg Regional Health Authority, Apheresis Department Not yet recruiting
Winnipeg, Manitoba, Canada, R3E 0T2
Contact: Cathy Moltzan, MD    204-787-4269    cmoltzan@sbgh.mb.ca   
Principal Investigator: Cathy Moltzan, MD         
Canada, New Brunswick
St. John Regional Hospital Not yet recruiting
St. John, New Brunswick, Canada, E2K5S9
Contact: Sean Dolan, MD    506-634-1201      
Principal Investigator: Sean Dolan, MD         
Canada, Ontario
Hamilton Health Sciences Recruiting
Hamilton, Ontario, Canada, L8N 3Z5
Contact: Julie Carruthers    905-525-9140 ext 22942    carrutj@mcmaster.ca   
Principal Investigator: Kathryn E Webert, MD         
Principal Investigator: Ronan Roley, MD         
Sub-Investigator: Donald M Arnold, MD         
London Health Sciences Centre, Westminister Campus Recruiting
London, Ontario, Canada, N6A4G5
Contact: Clark F William, MD    519-685-8500 ext 57238    william.clark@lhsc.on.ca   
Principal Investigator: William F Clark, MD         
Princess Margaret Hospital, ABMT/Apheresis Unit Recruiting
Toronto, Ontario, Canada, M5G2M9
Contact: David Barth, MD    416-946-4688    david.barth@uhn.on.ca   
Principal Investigator: David Barth, MD         
Canada, Quebec
Hopital Charles Lemoyne Not yet recruiting
Greenfield Park, Quebec, Canada
Contact: S Fox, MD    450-466-5000      
Principal Investigator: S Fox, MD         
Hopital du Sacre-Coeur de Montreal Not yet recruiting
Montreal, Quebec, Canada, H4J1C5
Contact: J P Moquin, MD    514-338-2222 ext 3368    jp.moquin@videotron.ca   
Principal Investigator: J P Moquin, MD         
Canada, Saskatchewan
St. Paul's Hospital Apheresis Unit Recruiting
Saskatoon, Saskatchewan, Canada, S7M 0Z9
Contact: Ahmed Shoker, MD    306-655-5934    ahmed.shoker@usask.ca   
Principal Investigator: Ahmed Shoker, MD         
Sponsors and Collaborators
Hamilton Health Sciences Corporation
Canadian Apheresis Group
Hoffmann-La Roche
McMaster University
Investigators
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Principal Investigator: Kathryn E Webert, E Hamilton Health Sciences Corporation
Principal Investigator: Ronan Foley, MD Hamilton Health Sciences Corporation
Study Director: Gail Rock, MD Canadian Apheresis Group
Study Director: William Clark, MD University of Western Ontario/London Health Sciences
Study Director: David Barth, MD University of Toronto
More Information
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Responsible Party: Canadian Apheresis Group
ClinicalTrials.gov Identifier: NCT00531089    
Other Study ID Numbers: CAG-1
First Posted: September 18, 2007    Key Record Dates
Last Update Posted: May 19, 2010
Last Verified: September 2007
Keywords provided by McMaster University:
TTP
thrombotic thrombocytopenic purpura
HUS
hemolytic uremic syndrome
plasma exchange
Additional relevant MeSH terms:
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Azotemia
Hemolytic-Uremic Syndrome
Purpura
Purpura, Thrombocytopenic
Purpura, Thrombotic Thrombocytopenic
Syndrome
Hemolysis
Disease
Pathologic Processes
Blood Coagulation Disorders
Hematologic Diseases
Hemorrhage
Skin Manifestations
Thrombotic Microangiopathies
Thrombocytopenia
 Blood Platelet Disorders
Cytopenia
Immune System Diseases
Uremia
Kidney Diseases
Urologic Diseases
Female Urogenital Diseases
Female Urogenital Diseases and Pregnancy Complications
Urogenital Diseases
Male Urogenital Diseases
Anemia, Hemolytic
Anemia
Thrombophilia
Rituximab
Antineoplastic Agents, Immunological