Myelodysplastic syndrome & Acute myeloid leukemia
Conditions
Interventions
Treatment group:Serenixol, Dexcitabine, Cytarabine, Aclamycin, Homoharringtonine, Demethoxydaunorubicin, Granulocyte colony stimulating factor
Sponsors
Hebei Provincial Hospital of Traditional Chinese Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 100 Years
Inclusion criteria
Inclusion criteria: 1. Be aware of this plan and voluntarily sign an informed consent form; 2. Age = 18 years old, regardless of gender; 3. Confirmed cases with primary AML or myelodysplastic syndrome (MDS) that meet the World Health Organization (WHO) 2022 classification criteria for hematopoietic and lymphocytic tissue tumors; 4. Newly diagnosed AML patients or MDS who are unable to tolerate or unwilling to undergo high-intensity chemotherapy; Or, after a course of standard induction chemotherapy (DA/IA 3+7 or low-intensity chemotherapy (Venacra+azacitidine, etc.) induction treatment, refractory or recurrent AML or MDS may occur; The definition of recurrence/refractory needs to meet any of the following conditions: ? Recurrence: defined as the reappearance of leukemia cells in peripheral blood or the proportion of bone marrow immature/primitive cells to bone marrow cells = 5% after the first-line treatment reaches CRMRD -, CR, CRi; ? Refractory: Primary refractory diseases that have not achieved "CR, Cri, CRh, MLFS" after at least one course of standard regimen induced chemotherapy; Subjects who do not meet the standard treatment conditions must have completed the optimal treatment for induced remission selected by the researcher after evaluation, and receive at least one complete treatment cycle for induced remission. 5. According to the judgment of the researcher, if the subject's disease is in a rapidly proliferating state and cannot wait for the test results of the central laboratory, the inclusion can be evaluated based on the test results of the local laboratory (which is a local or external hospital or third-party testing institution with regulatory laboratory qualification certification) conducted after the end of the subject's last intervention treatment; 6. The ECOG score is 0-2 points; 7. Expected survival time = 12 weeks; 8. After evaluation by the researchers, the subjects are suitable for receiving salvage chemotherapy selected by the experimental protocol; 9. The subjects must have appropriate organ function and meet all the following laboratory test results before enrollment: a) Coagulation function: International standardized ratio (INR)<1.5 × ULN (INR<1.8 when there is no normal reference range) and activated partial thromboplastin time (APTT) 1.5 × ULN; b) Electrolyte: Blood potassium = 3.0 mmol/L; Blood magnesium = 0.5 mmol/L; c) Liver function: ALT and AST = 2.5 × ULN; Serum bilirubin = 1.5 × ULN; d) Renal function: serum creatinine = 1.5 × ULN; Alternatively, the creatinine clearance rate (Ccr) calculated according to the Cockcroft Fault formula is greater than 50 mL/min. 10. The subjects must be willing to provide valid diagnostic evidence prior to treatment or undergo bone marrow examination, as well as undergo bone marrow examination after treatment; 11. Non lactating female subjects; For female subjects with fertility: During the screening period, the blood pregnancy test must be negative for pregnancy, and there is no IVF plan within 6 months after signing the informed consent form and the last medication used in the research treatment, and they agree to adopt efficient contraceptive measures. Unsterilized male subjects: Within 6 months after signing the informed consent form and taking the last medication for the study treatment, there was no plan to donate sperm and they agreed to adopt efficient contraceptive measures; 12. The subjects voluntarily participated in this study and were personally; 13. The subjects or their guar
Exclusion criteria
Exclusion criteria: 1. Those who have previously received Serenisos; 2. Acute and chronic GVHD subjects who have received hematopoietic stem cell transplantation within the first 2 months of randomization, or who have received anti GVHD treatment for graft versus host disease after hematopoietic stem cell transplantation during the screening period; 3. Before randomization, 4 weeks or = 5 × Subjects who have received chemotherapy, targeted therapy, anti-tumor immunotherapy (immune checkpoint inhibitors, CAR-T therapy, etc.), radiotherapy, or major surgery (excluding diagnostic surgery) within the half-life of the drug (if the half-life of the drug is specified, it is calculated as 5 times the half-life, otherwise it is 4 weeks); 4. Those who receive live vaccines (including attenuated live vaccines) within the first 4 weeks of randomization and/or plan to receive live vaccines after enrollment; 5. Participated in any intervention clinical trial and received intervention with investigational drugs or medical devices within the first 4 weeks of randomization (excluding participants in a study with overall survival follow-up); 6. Subjects diagnosed with acute promyelocytic leukemia; 7. The subject has BCR-ABL positive leukemia (chronic myeloid leukemia); 8. Malignant tumors other than AML that have merged within the first 5 years of randomization, excluding tumors that have a negligible risk of metastasis or death (if the expected 5-year OS is>90%) and are expected to be curable after treatment (such as cervical carcinoma in situ, skin basal cell carcinoma or squamous cell carcinoma, localized prostate cancer undergoing radical hand surgery, breast ductal carcinoma in situ undergoing radical surgery, etc.), Or any other tumor that has been cured (with no evidence of disease recurrence within 5 years).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Complete response rate, CR; | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective response rate, ORR;Safety and tolerability; | — |
Countries
China
Contacts
Public ContactZijing Guo
Hebei Provincial Hospital of Traditional Chinese Medicine
Outcome results
None listed