Myeloid Hematologic Diseases
Conditions
Interventions
Trial group:PD-1 monoclonal antibody and Chidamide
Sponsors
Chinese People's Liberation Army General Hospital
Eligibility
Sex/Gender
All
Age
14 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Patients with relapsed AML/MDS who have previously undergone allogeneic hematopoietic stem cell transplantation, diagnosed according to the 2016 WHO classification; 2. Age >=14 years; 3. ECOG =3 months; 4. Time from allogeneic hematopoietic stem cell transplantation to relapse >8 weeks; 5. Adequate organ function during screening, defined as follows: (1)Serum creatinine (Cr) =60 mL/min (Cockcroft-Gault formula); (2)Total bilirubin (BIL) <=1.5 times ULN; (3)Aspartate aminotransferase (AST/SGOT) or alanine aminotransferase (ALT/SGPT) levels <=3 times ULN; (4)International normalized ratio (INR) <=1.5, prothrombin time (PT) and activated partial thromboplastin time (APTT) <=1.5 times ULN; 6. Female subjects of childbearing potential must undergo urine or serum pregnancy testing; if urine test is positive or cannot be confirmed as negative, a serum pregnancy test is required; 7. Male and female subjects with reproductive potential must agree to use appropriate contraception during treatment and for 120 days after treatment; 8. Subjects are willing to understand and sign the informed consent form; 9. Discontinuation of immunosuppressive agents for 1 week.
Exclusion criteria
Exclusion criteria: 1. Received allogeneic hematopoietic stem cell transplantation within 8 weeks prior to signing informed consent; 2. Active grade 2 or higher acute graft-versus-host disease (GVHD) or moderate-to-severe chronic GVHD requiring pharmacologic treatment; 3. History of autoimmune disease, or presence of other acquired or congenital immunodeficiency disorders; 4. Active infection: active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection (HBV viral load >=2×10^3 IU/mL; HCV viral load >=1×10^3 IU/mL); active tuberculosis; 5. History of clinically significant cardiovascular disease, including: (1) congestive heart failure (NYHA Class >2); (2) unstable angina; (3) myocardial infarction within the past year; (4) any arrhythmia requiring treatment or intervention; 6. Hypoxemia; severe hepatic or renal impairment not meeting inclusion criteria; 7. Prior treatment with PD-1 inhibitors, PD-L1 inhibitors, or CTLA-4 inhibitors; 8. Currently participating in another clinical trial or less than 4 weeks since completion of prior clinical trial therapy; 9. Pregnant or lactating female patients; 10. Other conditions deemed by the investigator to potentially interfere with study conduct, prevent protocol adherence, compromise patient cooperation, or pose research risks—this study design excludes high-risk populations and potential confounding factors.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective Response Rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression-free survival;Overall survival;Number of patients experiencing graft-versus-host disease and other immune-related adverse events; | — |
Countries
China
Contacts
Public ContactGao Chunji
The First Medical Center of the Chinese People's Liberation Army General Hospital
Outcome results
None listed