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| ID | Type | Description | Link |
|---|---|---|---|
| OZM-099 | Other Identifier | Ozmosis Research Inc |
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| Name | Class |
|---|---|
| Cell Therapy Transplant Canada | UNKNOWN |
| Sanofi | INDUSTRY |
| Ozmosis Research Inc. | INDUSTRY |
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A Randomized Pilot Trial to test the feasibility of comparing anti-thymocyte globulin plus post transplant cyclophosphamide with anti-thymocyte globulin alone to prevent chronic graft versus host disease.
Patients with acute leukemia or myelodysplastic syndrome will be randomized to receive, or not receive, post transplant cyclophosphamide in addition to anti-thymocyte globulin.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ATG/PTCy | Experimental | Anti-Thymocyte Globulin (ATG, Thymoglobulin) 4.5 mg/kg IV (divided 0.5, 2.0, 2.0 mg/kg on days -2, -1 and +1); cyclophosphamide (Post Transplant Cyclophosphamide, PTCy) 50 mg/kg IV daily on days +3 and +4. |
|
| ATG | Active Comparator | Anti-Thymocyte Globulin (ATG, Thymoglobulin) 4.5 mg/kg IV (divided 0.5, 2.0, 2.0 mg/kg on days -2, -1 and +1). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cyclophosphamide | Drug | Post Transplant Cyclophosphamide |
| |
| Anti-Thymocyte globulin (rabbit) |
| Measure | Description | Time Frame |
|---|---|---|
| Registration of 80 patients within twenty four months | Registration will be documented by the Clinical Research Organization (Ozmosis Research Inc.) | 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| CRFS | Chronic graft versus host disease free- and relapse-free survival (CRFS) | 27 months |
| GRFS | Graft versus host disease-, and relapse-, free survival (GRFS) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Irwin R Walker, MBBS | McMaster University | Principal Investigator |
| Kristjan Paulson, MD | CancerCare Manitoba | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kinghorn Cancer Centre, St Vincent's Health Network | Darlinghurst | New South Wales | 2010 | Australia | ||
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| ID | Term |
|---|---|
| D000754 | Anemia, Refractory, with Excess of Blasts |
| D000092122 | Bronchiolitis Obliterans Syndrome |
| ID | Term |
|---|---|
| D000753 | Anemia, Refractory |
| D000740 | Anemia |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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| ID | Term |
|---|---|
| D003520 | Cyclophosphamide |
| D000961 | Antilymphocyte Serum |
| C512542 | thymoglobulin |
| ID | Term |
|---|---|
| D010752 | Phosphoramide Mustards |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
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Randomized pilot trial
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| Drug |
Anti-Thymocyte Globulin (rabbit, Thymoglobulin) |
|
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| 27 months |
| Survival | Survival (dead/alive) at 100 days for each patient | 27 months |
| Complete data collection | The Clinical Research Organization (Ozmosis Research Inc.) will document completeness of data collection | 27 months |
| Cost of study | The sponsor (McMaster University) and the Clinical Research Organization (Ozmosis Research Inc.) will compare actual total trial costs in Canadian dollars at trial completion (at completion of outcomes analysis and report) with expected costs as determined for the trial budget. | 27 months |
| Royal North Shore Hospital |
| St Leonards |
| New South Wales |
| 2065 |
| Australia |
| Australasian Leukaemia and Lymphoma Group | Melbourne | Victoria | 3121 | Australia |
| CancerCare Manitoba | Winnipeg | Manitoba | R3E 0V9 | Canada |
| Queen Elizabeth II Health Sciences Centre | Halifax | Nova Scotia | B3H 2Y9 | Canada |
| Juravinski Hospital and Cancer Centre | Hamilton | Ontario | L8V 1C3 | Canada |
| London Health Sciences Centre | London | Ontario | N6A 5W9 | Canada |
| Hôpital de l'Enfant-Jésus | Québec | Quebec | G1R 2J6 | Canada |
| Saskatchewan Cancer Agency | Saskatoon | Saskatchewan | S7N 4H4 | Canada |
| D009190 |
| Myelodysplastic Syndromes |
| D001855 | Bone Marrow Diseases |
| D000092124 | Organizing Pneumonia |
| D001989 | Bronchiolitis Obliterans |
| D001988 | Bronchiolitis |
| D001991 | Bronchitis |
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D006086 | Graft vs Host Disease |
| D007154 | Immune System Diseases |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D063088 | Phosphoramides |
| D009943 | Organophosphorus Compounds |
| D007106 | Immune Sera |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |