19
Participants
Start Date
March 15, 2019
Primary Completion Date
March 31, 2024
Study Completion Date
June 30, 2024
Up-front allogeneic hematopoietic stem cell transplantation (HSCT)
"Patients classified as fit/unfit are included in the HSCT program. There are two early approaches allowed. A) Patients will be left untreated until HSCT B) Patients will receive 1 short course of chemotherapy before HSCT (Ara-C and anthracycline).~Selection of strategy A or B, will be patient based on disease characteristics and dynamics or presence of high tumor load.~Conditioning for haplo-HSCT should be started as soon as possible, within day 45 after initial diagnosis. This is to avoid delayed transplantation. Two dosing levels of the Thiotepa-Busulfan-Fludarabine (TBF) based protocol are allowed based on the clinical condition of the patient: fit patients below 70 will receive the TBF with 2 days of Busulfan, whereas patients with poorer clinical condition or above the age of 70 will receive a dose-reduced TBF, in which Busulfan may be reduced to 1 day only."
Fondazione Policlinico Universitario A. Gemelli IRCCS, Roma
Associazione Italiana per la Ricerca sul Cancro
OTHER
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
OTHER