Haematological Malignancies Clinical Trial
Allogeneic haematopoietic stem cell transplantation (HSCT) is a potentially curative therapy
for patients with both haematological and some non-haematological disorders. However, one of
the major limiting factors for transplantation is the inability to identify a suitable
HLA-matched donor. Development of an cost-effective and clinically efficacious alternative
to HLA-identical sibling or unrelated donor transplantation would significantly expand the
availability of allogeneic HSCT to patients in Singapore. Preliminary results indicate that
the use of high dose post-transplant cyclophosphamide (Cy) for graft versus host disease
(GVHD) prophylaxis in haplo-identical allogeneic HSCT is associated a low incidence of GVHD
and low treatment related toxicity. We propose a phase II clinical trial to assess the
efficacy of a haplo-identical allogeneic transplantation protocol using high dose
post-transplant Cy for the treatment of patients with haematological disorders. A
non-myeloablative protocol (Fludarabine-low dose cyclophosphamide-TBI) will be used for
patients with bone marrow failure syndromes and indolent lymphoid disease. In view of the
higher relapse risk of patients with myeloid malignancies, these patients will be treated
with a reduced intensity conditioning regimen (Fludarabine-Busulphan). The primary end-point
of the study will be overall survival at one year. Economic cost of the haplo-identical
transplantation, as well as treatment timelines will be recorded and compared will other
forms of unrelated donor allogeneic transplantation (umbilical cord blood transplantation
and unrelated HLA-matched adult donor). Immunological reconstitution of patients following
haplo-transplantation will be analysed and data will be utilized to guide future
immunotherapy strategies post-transplantation.
One year survival after non-myeloablative haploidentical stem cell transplantation is not
inferior to that observed after non-myeloablative volunteer unrelated donor or unrelated
cord blood haematopoietic stem cell transplantation.
n/a
Observational Model: Cohort, Time Perspective: Prospective
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