This study intends to evaluate the efficiency and safety of M-PTCy as conditioning regimen in Haploidentical HSCT for Acute Leukemia, so as to provide a new conditioning regimen for allogeneic hematopoietic cell transplantation.
Haploidentical related donor transplantation is now considered an important alternative to allogeneic hematopoietic stem cell transplantation (allo-HSCT). Posttransplant cyclophosphamide (PTCy) has revolutionized Haplo HCT with acceptable rates of engraftment, graft-versus-host disease (GVHD), relapse, and survival.To prolonger PFS, OS and alleviate GVHD, we combined Mitoxantrone liposomes with PTCy as conditioning regimen in allogeneic hematopoietic cell transplantation.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
60
Mitoxantrone liposomes with 36mg/m2 and Bu 3.2mg/kg -5 to -4, Flu 30mg/m2 -12 to -9, Ara-C 1.5g/m2 -12 to -9,CTX 15mg/kg/d -3 to -2, was used as conditioning regimen, Post Transplant Cyclophosphamide 50 mg/kg IV daily on days +3 and +4.
Control group:the conditioning regimen involved Ara-C 2g/m2 q12h -8, BU 3.2 mg/kg -7 to -5,CTX 1.8 g/m2 -4 to -3, to prevent GVHD, MTX 15mg/m2 +1d, 10mg/m2 +3,+6,+11,CsA 3mg/kg/d from -8d,MMF 1g q12h from -8d, ATG 2.5mg/kg/d -5 to -2.
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, China
RECRUITINGProgression-free survival (PFS)
It is defined as the total survival of a patient after CR until the tumor recurrence or death from any cause.
Time frame: From the 1st day to 2 years after enrollment
Overall survival (OS)
The time from randomization to death from any cause.
Time frame: From the 1st day to 2 years after enrollment
incidence of GVHD
The incidence of graft-versus-host disease
Time frame: From the 1st day to 2 years after enrollment
CMV and EBV activation
The incidencance of cytomegalovirus and Epstein-barr virus infection
Time frame: From the 1st day to 2 years after enrollment
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.