Acute myeloid leukemia
Conditions
Interventions
Therapy group:Cedaramine 5 mg/d combined with azacitidine 75 mg/m2/d for 5 days.6-8 weeks for 1 cycle.A total of 6 cycles treatment was given.
Sponsors
Soochow Hopes Hematology Hospital
Eligibility
Sex/Gender
All
Age
No minimum to 60 Years
Inclusion criteria
Inclusion criteria: 1. Patients with high-risk acute myeloid leukemia after allogeneic hematopoietic stem cell transplantation; AML was diagnosed according to the WHO criteria in 2022, 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 2022; (2) Primary refractory or recurrent AML; (3) Secondary AML (secondary to MDS or treatment-related AML); 2. When signing the informed consent form, the main organ functions need to meet the following conditions: (1) Echocardiographic left ventricular ejection fraction>=50%; (2) Creatinine 91%; 3. Voluntarily participated in the study and signed informed consent; 4. Age below 60 years old (including 60 years old), unlimited gender; 5. 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 the study drug. For men, they should be sterilized by surgery or agree to use effective methods of contraception during the study period and within 90 days after the last administration of study drugs; 6. ECOG score 0-1; 7. The estimated survival time is more than 3 months.
Exclusion criteria
Exclusion criteria: 1. With other malignant tumors; 2. With acute or chronic GVHD; 3. Morphological relapse, central nervous leukemia, extramedullary infiltration; 4. Previous treatment with other pharmacological interventions after transplantation; 5. Known history of hepatitis B (HBsAg-positive) or hepatitis C (HCV-positive). Occult or pre-infected hepatitis B subjects (defined as HBcAb positive and HBsAg negative) can be enrolled if they have a negative PCR test for HBV DNA, and these subjects need to have monthly PCR tests for HBV DNA. HCV antibody serologically positive subjects can also be enrolled if they have a negative PCR test for HCV RNA; 6. Presence of bacterial, fungal, viral, mycoplasma, or other types of infection that, in the judgment of the investigator, are difficult to control; 7. HIV, syphilis, and COVID-19 infection; 8. Prior or current CNS disease such as seizures, cerebrovascular ischemia/hemorrhage, dementia, cerebellar disease, or any CNS-related autoimmune disease; 9. Cardiac angioplasty or stent placement within 12 months prior to signing the informed consent form, or a history of myocardial infarction, unstable angina, or other clinically significant cardiac disease; 10. With primary immunodeficiency; 11. Have had severe tachyphylaxis to any of the drugs to be used in this study; 12. Live vaccination within 6 weeks prior to screening; 13. Pregnant or breastfeeding women; 14. Active autoimmune diseases; 15. Conditions deemed by the investigator to be inappropriate for participation in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 2-year cumulative recurrence rate (CIR); | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival (OS);Leukemia free survival (LFS);Safety; | — |
Countries
China
Contacts
Public ContactXiaohui Hu
Soochow Hopes Hematology Hospital
Outcome results
None listed