Use of Haploidentical Related Donors for Patients Without Matched Sibling, Unrelated Donor or Cord Blood Units

Official Title

Use of Haploidentical Related Donors for Patients Without Matched Sibling, Unrelated Donor or Cord Blood Units

Summary:

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.

Trial Description

Primary Outcome:

  • Six month survival, free from relapse, graft failure and grade III/IV acute GVHD
Secondary Outcome:
  • Incidence of Grade III/IV Acute Graft Versus Host Disease
  • Incidence of Chronic Extensive Graft Versus Host Disease
  • Cumulative incidence of non-relapse mortality at 1 year
  • Graft failure rate (ANC < 0.5 and low donor chimerism)
  • Overall and Disease Free Survival
  • Relapse Rate
  • Patients remaining on immune suppression at 1 year
  • Incidence of CMV and EBV reactivation requiring treatment

View this trial on ClinicalTrials.gov

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Resources

Canadian Cancer Society

These resources are provided in partnership with the Canadian Cancer Society