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| Name | Class |
|---|---|
| The Canadian Blood and Marrow Transplant Group | NETWORK |
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The administration of high-dose chemotherapy followed by the infusion of blood or bone marrow stem cells (stem cell transplantation) from a matched donor has become standard treatment for patients with high-risk or relapsed hematological cancers. Currently, donors are found for approximately 80% of people who require such treatment, although the chance of finding a donor is much lower in some ethnic communities. In the current study the investigators will offer patients requiring transplantation, but for whom well matched donors cannot be identified either from within the family or on the donor registry, a transplant from a half-matched (haploidentical) family member. A myeloablative conditioning regimen and un-manipulated peripheral blood stem cells will be used. Post-transplant cyclophosphamide, tacrolimus and mycophenolate mofetil will be used to prevent graft versus host disease (GVHD). The primary outcome measure will be 6 month survival free from graft failure, relapse and grade 3-4 acute GVHD. Other outcomes of interest will include the frequency of Cytomegalovirus (CMV) or Epstein-Barr Virus (EBV) requiring treatment, overall survival and progression-free survival.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| T-Cell replete haplo-transplant | Experimental | Infusion of peripheral blood stem cells from a haploidentical related donor following myeloablative conditioning. Cyclophosphamide, mycophenolate mofetil and tacrolimus will be given for GVHD prophylaxis. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| T-Cell replete haplo-transplant | Procedure | Infusion of haploidentical related donor peripheral blood stem cells following myeloablative conditioning (fludarabine 200 mg/m2, busulfan 12.8 mg/kg and total body irradiation (TBI) 400 centigray -or- fludarabine 200 mg/m2, busulfan 9.6 mg/kg). GVHD prophylaxis will be with cyclophosphamide 50 mg/kg/day x 2 on days 3 & 4, mycophenolate mofetil 1 gm p.o. bid days 5 - 35 and tacrolimus (5-15 ug/ml) days 5 - 100. |
| Measure | Description | Time Frame |
|---|---|---|
| Six month survival, free from relapse, graft failure and grade III/IV acute GVHD | Six months |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Grade III/IV Acute Graft Versus Host Disease | Six months | |
| Incidence of Chronic Extensive Graft Versus Host Disease | One year | |
| Cumulative incidence of non-relapse mortality at 1 year |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Andrew Daly, MD | University of Calgary | Principal Investigator |
| Kristjan Paulson, MD | University of Manitoba | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Foothills Medical Center / Tom Baker Cancer Center | Calgary | Alberta | T2N 4N2 | Canada | ||
| Health Sciences Center |
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| ID | Term |
|---|---|
| D019337 | Hematologic Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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|
| One year |
| Graft failure rate (ANC < 0.5 and low donor chimerism) | Six months |
| Overall and Disease Free Survival | One year |
| Relapse Rate | One year |
| Patients remaining on immune suppression at 1 year | One year |
| Incidence of CMV and EBV reactivation requiring treatment | One year |
| Winnipeg |
| Manitoba |
| R3A 1R9 |
| Canada |
| Ottawa General Hospital | Ottawa | Ontario | K1H 8L6 | Canada |
| McGill University Health Centre | Montreal | Quebec | H4A 3J1 | Canada |
| Royal University Hospital | Saskatoon | Saskatchewan | S7N 0W8 | Canada |