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Clinical Trial 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%.


Clinical Trial Description

n/a


Study Design


Related Conditions & MeSH terms


NCT number NCT03902665
Study type Interventional
Source Policlinico Universitario Agostino Gemelli
Contact
Status Enrolling by invitation
Phase Phase 2
Start date March 15, 2019
Completion date March 30, 2021

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