Leukemia, Myeloid, Acute
Conditions
Brief summary
The goal of this phase I/II clinical trial is to test in high-risk acute myeloid leukemia (AML) patients undergoing allogeneic hemopoietic stem-cell transplantation (allo-HSCT). The main question it aims to answer is: • The efficacy and safety of chidamide maintenance therapy in reducing the recurrence rate and GVHD incidence in high-risk AML patients after allo-HSCT. Participants will take oral chidamide (Epidaza) until 180 days after allo-HSCT.
Interventions
DRUGChidamide
initial time：platelet count ≥50×10\^9/L after allo-HSCT initial dose: 5 mg oral twice weekly initial adjustment: according to the platelet count tested weekly platelet count ≥50×10\^9/L-increased by 5 mg 20×10\^9/L≤ platelet count \<50×10\^9/L-remains unchanged platelet count \<50×10\^9/L- reduced by 5 mg maximum dose: 20 mg oral twice weekly terminal time: 180 days after allo-HSCT
Sponsors
Sichuan University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
1. Age ≥ 18 years old and ≤ 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 ≥ 0.5×10\^9/L for 3 consecutive days without G-CSF application, platelet count ≥ 20×10\^9/L for 7 consecutive days without platelet transfusion, Hb ≥ 80 g /L without red blood cell transfusion); and neutrophil count ≥ 1.5×10\^9/L, platelet count ≥ 50×10\^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
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 | Description |
|---|---|---|
| Progression free survival (PFS) | 2 years | Progression free survival of this group of patients at the end of 2 year |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Non-relapse mortality (NRM) | 6 months | Non-relapse mortality of this group of patients at the end of 6 month |
| Overall survival (OS) | 2 years | Overall survival of this group of patients at the end of 2 year |
| 100 day adverse events (AE) | Day +100 | non-hematologic adverse events |
| Cumulative incidence of acute graft versus host disease (aGVHD) | Day +100 | Cumulative incidence of acute graft versus host disease (aGVHD) of this group of patients at day+100 |
| Cumulative incidence of chronic graft versus host disease (cGVHD) | 2 years | Cumulative incidence of chronic graft versus host disease (cGVHD) of this group of patients at the end of 2 year |
| Relapse rate | 2 years | Relapse rate of this group of patients at the end of 2 year |
Countries
China
Outcome results
None listed