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

PHASE2CompletedINTERVENTIONAL
Enrollment

19

Participants

Timeline

Start Date

March 15, 2019

Primary Completion Date

March 31, 2024

Study Completion Date

June 30, 2024

Conditions
Acute Myeloid Leukemia, Adult
Interventions
DRUG

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."

Trial Locations (1)

00168

Fondazione Policlinico Universitario A. Gemelli IRCCS, Roma

All Listed Sponsors
collaborator

Associazione Italiana per la Ricerca sul Cancro

OTHER

lead

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

OTHER

NCT03902665 - Up-front Hematopoietic Stem Cell Transplantation in Acute Myeloid Leukemia Patients Aged 65-75 | Biotech Hunter | Biotech Hunter