Efficacy and Safety of Selinexor Combined with Azacitidine as Maintenance Therapy in High-Risk Myeloid Neoplasms Patients Post-Transplantation: A Single-Center, Single-Arm, Exploratory Study
Treatment period: From the time of transplantation, after screening by inclusion and exclusion criteria, patients who meet the criteria are enrolled and given maintenance therapy with Selinexor in combination with azacitidine (Selinexor: 40 mg/weekly, administered on D1; azacitidine: 50 mg/m2\*5d; every 28 days for a cycle of treatment, for at least one year of medication, or until progression of the disease, or until the development of intolerable toxicity, whichever comes first)
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
maintenance therapy with Selinexor combined with Azacitidine in patients with high-risk myeloid neoplasms after transplantation
Institute of Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciences, Tianjin, China.
Tianjin, China
2-year recurrence free survival rate (RFS)
the rate at which a patient has been on the drug for at least 1 year without morphological relapse or death of the subject from the transplantation date (whichever comes first)
Time frame: 2 years
2-year non-relapse mortality rate (NRM)
incidence of death from causes other than AML relapse/progression from the date of transplantation to the date of the subject's death
Time frame: 2 years
2-year survival rate (OS)
the 2-year survival rate from transplantation to death from any causes
Time frame: 2 years
Median overall survival (OS)
The time from transplantation to death from any causes
Time frame: 2 years
Cumulative incidence of acute graft-versus-host disease (GVHD)
Cumulative incidence of grade II-IV acute GVHD at 6 months after enrollment. Acute GVHD will be graded based on the diagnostic and severity scores used by the Blood and Bone Marrow Transplantation Clinical Trial Network (BMTCTN).
Time frame: 2 years
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