A multicentre, prospective, open-label clinical study, including a randomized controlled study in low or intermediate-risk group patients, and a cohort study of maintenance treatment with decitabine after ASCT.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
212
Patients randomly assigned in to either of groups will receive either autologous SCT or haplo-SCT after CR1 is achieved.
The Fisrt Affiliated Hospital of Soochow University
Suzhou, Jiangsu, China
RECRUITINGLeukemia-Free Survival
Defined as the survival duration starting at the day of graft infusion, terminating at the day of death, morphological relapse or the end of follow-up.
Time frame: Five years
Overall survival
Defined as the survival duration starting at the day of graft infusion, terminating at the day of death or the end of follow-up.
Time frame: Five years
Cumulative relapse incidence
Defined as the cumulative incidence of morphological relapse after the day of graft infusion.
Time frame: Five years
Non-relapse Mortality
Defined as the cumulative incidence of death without cause of disease recurrence, which include the cause of GVHD, infection, hemorrhage, organic function failure, etc.
Time frame: Five years
Cumulative incidence of engraftment
Defined as the cumulative incidence of durable complete donor chimerism detected by STR-PCR.
Time frame: 180 days
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