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| Name | Class |
|---|---|
| Canadian Apheresis Group | OTHER |
| Hoffmann-La Roche | INDUSTRY |
| McMaster University | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Study group | Experimental | All patients in the study will be in the study group and will receive rituximab. There is no "control" arm. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rituximab | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 8 weeks after initiation of therapy |
| Measure | Description | Time Frame |
|---|---|---|
| proportion of patients with platelet count greater than 150 x 109/L | 8 weeks | |
| proportion of patients with LDH < 1.5 X normal | 8 weeks | |
| proportion of patients with no requirement for plasma exchange therapy |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Kathryn E Webert, MD | Contact | 905-521-2100 | 76733 | webertk@mcmaster.ca |
| Name | Affiliation | Role |
|---|---|---|
| Kathryn E Webert, E | Hamilton Health Sciences Corporation | Principal Investigator |
| Ronan Foley, MD | Hamilton Health Sciences Corporation | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Foothills Medical Centre, Calgary Health REgion Apheresis Service | Not yet recruiting | Calgary | Alberta | T2N 2T9 | Canada |
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| ID | Term |
|---|---|
| D011697 | Purpura, Thrombotic Thrombocytopenic |
| D006463 | Hemolytic-Uremic Syndrome |
| ID | Term |
|---|---|
| D011696 | Purpura, Thrombocytopenic |
| D011693 | Purpura |
| D001778 | Blood Coagulation Disorders |
| D006402 | Hematologic Diseases |
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| ID | Term |
|---|---|
| D000069283 | Rituximab |
| ID | Term |
|---|---|
| D058846 | Antibodies, Monoclonal, Murine-Derived |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
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|
|
| 8 weeks |
| proportion of patients who are asymptomatic (no new neurological symptoms ans stabilization of previous neurological symptoms | 8 weeks |
| clinical response (CR, PR, non-response) | 52 weeks |
| frequency of relapse | 52 weeks |
| mortality | 52 weeks |
| changes from baseline in platelet counts, LDH, ADAMTS13 protease level, ADAMTS13 inhibitor level | 8, 12, 24, 52 weeks |
| toxicity and clinical safety as assessed by monitoring of adverse events, laboratory parameters, vital signs during infusion, and immediate tolerability | 8 weeks |
| 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 | Study Director |
| University of Alberta Hospital | Not yet recruiting | Edmonton | Alberta | Canada |
|
| Vancouver General Hospital | Recruiting | Vancouver | British Columbia | V5Z1M9 | Canada |
|
| Winnipeg Regional Health Authority, Apheresis Department | Not yet recruiting | Winnipeg | Manitoba | R3E 0T2 | Canada |
|
| St. John Regional Hospital | Not yet recruiting | Saint John | New Brunswick | E2K5S9 | Canada |
|
| Hamilton Health Sciences | Recruiting | Hamilton | Ontario | L8N 3Z5 | Canada |
|
| London Health Sciences Centre, Westminister Campus | Recruiting | London | Ontario | N6A4G5 | Canada |
|
| Princess Margaret Hospital, ABMT/Apheresis Unit | Recruiting | Toronto | Ontario | M5G2M9 | Canada |
|
| Hopital Charles Lemoyne | Not yet recruiting | Greenfield Park | Quebec | Canada |
|
| Hopital du Sacre-Coeur de Montreal | Not yet recruiting | Montreal | Quebec | H4J1C5 | Canada |
|
| St. Paul's Hospital Apheresis Unit | Recruiting | Saskatoon | Saskatchewan | S7M 0Z9 | Canada |
|
| D006425 |
| Hemic and Lymphatic Diseases |
| D057049 | Thrombotic Microangiopathies |
| D013921 | Thrombocytopenia |
| D001791 | Blood Platelet Disorders |
| D000095542 | Cytopenia |
| D019851 | Thrombophilia |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012877 | Skin Manifestations |
| D012816 | Signs and Symptoms |
| D014511 | Uremia |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D000743 | Anemia, Hemolytic |
| D000740 | Anemia |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |