Leukemia
Conditions
Interventions
Therapy group:Chidamide 20 mg/time, twice a week for 2 years after transplantation
Sponsors
Aerospace Center Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. AML was diagnosed according to the WHO criteria in 2016, and its high-risk characteristics were defined as one or more of the following criteria: (1) Patients with poor prognosis according to the genetic risk stratification assessment of ELN in 2017; (2) Primary refractory or recurrent AML; (3) Secondary AML (secondary to MDS or treatment-related AML); (4) AML extramedullary infiltration; 2. The study drug chidamide was used within 80-150 days after transplantation; 3. Aged >= 18 years and 60 or ECOG score 0-2; 5. The estimated survival time is more than 3 months; 6. Allogeneic hematopoietic stem cell transplantation recipients who received myeloablative or non myeloablative pretreatment scheme, and the pretreatment scheme shall be determined by the investigator; 7. Hematopoietic reconstitution criteria were met after transplantation (absolute neutrophil count(ANC) >= 0.5 x 10^9/L for 3 consecutive days); 8. No central nervous system involvement and clinical symptoms; 9. No serious functional impairment of important organs of the whole body; 10. Fully understand and know the study and sign the informed consent form (ICF); and be willing to follow and able to complete all test procedures; 11. Fertile women must have a serum pregnancy test within 7 days before the first medication, and the result is negative; Fertile female subjects and partners shall agree to take effective contraceptive measures from the signing of ICF to 6 months after the last dose of study drug.
Exclusion criteria
Exclusion criteria: 1. There are important organ basic diseases: such as myocardial infarction, chronic cardiac insufficiency, decompensated liver insufficiency, renal insufficiency, gastrointestinal insufficiency, etc; 2. Clinically uncontrolled active infection (including bacterial, fungal or viral infection), and drug treatment is ineffective; 3. Participating in other clinical studies, or planning to start the treatment of this study, less than 4 weeks from the end of the treatment of the previous clinical study; 4. Poor graft function(PGF) occurred after allo-HSCT; 5. Patients with other malignant tumors requiring treatment; 6. Active GVHD; 7. History of allergy to sidabelamine; 8. Lactating women; 9. Patients with known history of human immunodeficiency virus(HIV) infection and/or acquired immunodeficiency syndrome; 10. Patients with chronic hepatitis B or active hepatitis C; 11. History of prolonged QT interval syndrome; 12. Patients considered unsuitable by other researchers to participate in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 2-year cumulative recurrence rate (CIR); | — |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of acute and chronic graft versus host disease;Transplant related mortality (TRM);Overall survival (OS);Leukemia free survival (LFS);Safety; | — |
Countries
China
Contacts
Public ContactWang Jingbo
Aerospace Center Hospital
Outcome results
None listed