haematologic malignancies
Conditions
Interventions
Trial group:Chidamide
Sponsors
West China Hospital, Sichuan University
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18-65 years old when signing the Informed Consent Form (ICF); 2. KPS score > 60 or ECOG score 0-2; 3. The expected survival period > 3 months; 4. Received allo-HSCT and achieved complete remission (CR); 5. Reach the standard of hematopoietic reconstitution (neutrophil count >= 0.5 x 10^9/L for 3 consecutive days without G-CSF application, platelet count >= 20 x 10^9/L for 7 consecutive days without platelet transfusion, Hb >= 80 g /L without red blood cell transfusion); and neutrophil count >= 1.5 x 10^9/L, platelet count >= 50 x 10^9/L within 45 days after transplantation; 6. No central nervous system involvement or clinical symptoms after transplantation; 7. Those who have no serious functional damage to important organs of the body; 8. Fully understand and be informed of this study and sign the ICF; willing to follow and have the ability to complete all test procedures; 9. Females of childbearing age must afford a serum pregnancy test within 7 days before the first dose, and the result should be negative; female participants and their partners should agree to use effective contraception from signing the ICF until 6 months after the last dose.
Exclusion criteria
Exclusion criteria: 1. Serious basic diseases of important organs: such as myocardial infarction, chronic cardiac insufficiency, decompensated hepatic insufficiency, renal function, gastrointestinal insufficiency, etc.; 2. Uncontrolled active infection (including bacterial, fungal, or viral infection), and drug treatment is ineffective; 3. Participating in other clinical studies, or planning to start treatment in this study and less than 4 weeks before the end of treatment in the previous clinical study; 4. Poor graft function (PGF) occurred after allo-HSCT; 5. Combined with other malignant tumors and require treatment; 6. Active GVHD; 7. Have a history of allergy to Chidamide; 8. Pregnant or lactating females; 9. Patients with known history of human immunodeficiency virus (HIV) virus infection and/or acquired immunodeficiency syndrome; 10. Patients with active chronic hepatitis B or active hepatitis C; 11. History of prolonged QT syndrome; 12. Patients considered by other researchers to be unsuitable for this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Relapse rate;Progression free survival (PFS); | — |
Secondary
| Measure | Time frame |
|---|---|
| Non-relapse mortality (NRM);Overall survival (OS);Cumulative incidence of acute graft versus host disease (aGVHD);Cumulative incidence of chronic graft versus host disease (cGVHD); | — |
Countries
China
Contacts
Public ContactJie Ji
West China Hospital, Sichuan University
Outcome results
None listed