A Phase 2 interventional study of Chidamide and Cyclophosphamide in Leukemia, Acute and MDS, sponsored by Sichuan University. Status unknown at 2 sites in China. Open to participants aged 16 Years to 65 Years. Per ClinicalTrials.gov, last updated 2018-07-18.
Sponsored by Sichuan University · Phase 2, Interventional, and Treatment
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.
Exclusion Criteria:
Chidamide, tablets, 5 mg/tablet, 20 mg orally twice weekly from D-7\~+14 Cyclophosphamide: 50 mg/Kg intravenously D+3, +4 Cyclosporine A: intravenously then orally 3 mg/Kg D+5\~D+100
Drug: Chidamide · Drug: Cyclophosphamide · Drug: cyclosporine A
20 mg orally, twice weekly from D-7 to D+14
Also known as: HBI-8000
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
Also known as: cyclosporine
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
Plan to share: No
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Sichuan University