Overview

Up-front Hematopoietic Stem Cell Transplantation in Acute Myeloid Leukemia Patients Aged 65-75

Status:
Unknown status
Trial end date:
2021-03-30
Target enrollment:
Participant gender:
Summary
Patients with acute myeloid leukemia aged 65-75 have a very poor prognosis, irrespective of the treatment strategy, including demethylating agents or conventional chemotherapy. With these approaches, remission rates do not exceed 40%, and overall disease-free survival at 1 year is in the order of 15%. The hypothesis is that up-front allogeneic hematopoietic stem cell transplant will produce a complete remission rate of 60% on day +56-70, and disease-free survival at 1 year of 30%. This is a single arm phase II study of upfront allogeneic stem cell transplantation, for patients with acute myeloid leukemia aged 65-75: the primary endpoint is a complete remission rate on day +56-70. The secondary endpoint is a 1-year overall disease-free survival of 30%.
Phase:
Phase 2
Details
Lead Sponsor:
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Policlinico Universitario Agostino Gemelli
Collaborator:
Associazione Italiana per la Ricerca sul Cancro