This study is to explore the efficacy and safety of introduction of chidamide in PTCy based GVHD prophylaxis in patients undergoing allogeneic PBSCT.
Eligible patients were aged 16 to 65 years, diagnosed with hematologic malignancy, and had a Karnofsky performance score of ≥70% and were candidates for myeloablative HCT. A 8/8 HLA allelic match between the donor and the recipient at HLA-A, HLA-B, HLA-C, and HLA-DRB1 by high-resolution typing was required. The graft source was PBSC. Patients received a myeloablative conditioning regimen consisting of oral chidamide given twice weekly at a dose of 20 mg from day -7 to 2 weeks post transplantation, intravenous busulfan 3.2 mg/kg from day -6 to -3, intravenous fludarabine 30 mg/m2 and cytarabine 1g/m2 respectively from day -6 to -2. PBSCs were infused on day 0. GVHD prophylaxis was post-transplantation cyclophosphamide (50 mg/kg on day +3, +4) and cyclosporine (started from day +5). In the absence of GVHD, cyclosporine tapering started on day +100 and discontinued on day +180. Minimal residual disease (MRD) was determined by multi-parameter flow cytometry.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
50
20 mg orally, twice weekly from D-7 to D+14
50 mg/Kg intravenously D+3, +4
3 mg/Kg intravenously then orally from D+5 to D+100 if no acute graft-versus-host disease
West China Hospital of Sichuan University
Chengdu, Sichuan, China
West China Hospital of Sichuan University
Chengdu, Sichuan, China
aGVHD
accumulated incidence of aGVHD
Time frame: 100 day after infusion of PBSCs
GRFS
GVHD free, relapse free survival
Time frame: 3 years after recruitment
DFS
Disease free survival
Time frame: 3 years after recruitment
OS
Overall survival
Time frame: 3 years after recruitment
cGVHD
accumulated incidence of cGVHD
Time frame: 2 yeas after infusion of PBSCs
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