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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
40
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.
Foothills Medical Center / Tom Baker Cancer Center
Calgary, Alberta, Canada
Health Sciences Center
Winnipeg, Manitoba, Canada
Ottawa General Hospital
Ottawa, Ontario, Canada
McGill University Health Centre
Montreal, Quebec, Canada
Royal University Hospital
Saskatoon, Saskatchewan, Canada
Six month survival, free from relapse, graft failure and grade III/IV acute GVHD
Time frame: Six months
Incidence of Grade III/IV Acute Graft Versus Host Disease
Time frame: Six months
Incidence of Chronic Extensive Graft Versus Host Disease
Time frame: One year
Cumulative incidence of non-relapse mortality at 1 year
Time frame: One year
Graft failure rate (ANC < 0.5 and low donor chimerism)
Time frame: Six months
Overall and Disease Free Survival
Time frame: One year
Relapse Rate
Time frame: One year
Patients remaining on immune suppression at 1 year
Time frame: One year
Incidence of CMV and EBV reactivation requiring treatment
Time frame: One year
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.