Myelodysplastic syndrome & Acute myeloid leukemia
Conditions
Interventions
Treatment group:Decitabine , Venecra and Selinisol
Sponsors
The Second Hospital of Hebei Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 100 Years
Inclusion criteria
Inclusion criteria: 1. Know the plan and sign the informed consent voluntarily 2. Age =18 years old, gender unlimited 3. Patients diagnosed with primary AML or myelodysplastic syndrome (MDS) according to the World Health Organization (WHO) 2022 Classification criteria for Hematopoietic and lymphocytic tissue tumors 4. Newly diagnosed AML patients or MDS patients who cannot tolerate high-intensity chemotherapy or are unwilling to accept high-intensity chemotherapy; Refractory or recurrent AML or MDS developed after a course of standard induction chemotherapy (DA/IA 3+7 or low-intensity chemotherapy (Veneckra + azacitidine, etc.); The definition of recurrence/refractory should meet any of the following conditions: (1) Recurrence: defined as the re-emergence of leukemia cells in peripheral blood or the ratio of naive/primitive cells in bone marrow to bone marrow cells =5% after first-line treatment reaches CRMRD-, CR, CRi; ? Difficult to treat: no primary refractory diseases of "CR, CRi, CRh, MLFS" were obtained after at least 1 course of chemotherapy induced by the standard regimen; Subjects who do not meet standard treatment conditions must have completed the optimal treatment for induced remission selected after investigator evaluation and have received at least one full cycle of induced remission therapy. 5. According to the judgment of the investigator, the subject's disease is in a state of rapid proliferation and cannot wait for the test results of the central laboratory, the subject can be evaluated and enrolled according to the test results of the local laboratory (which is the laboratory qualification certification of the regulatory department or other hospitals or third-party testing institutions) conducted after the end of the last intervention treatment; 6.ECOG score is 0-2 points; 7. Expected survival =12 weeks; 8. As assessed by the investigator, the subject is suitable to receive salvage chemotherapy selected in the trial protocol; 9. Subjects must have appropriate organ function and meet all of the following laboratory results prior to enrollment: a) Coagulation function: International Normalized ratio (INR) 50 mL/min as calculated by the Cockcroft-Gault formula. 10. Subjects must be willing to provide valid diagnostic evidence or undergo bone marrow examination prior to treatment and undergo bone marrow examination after treatment; 11. Non-lactating female subjects; For fertile female subjects, the blood pregnancy test during the screening period must be pregnancy negative, there must be no IVF egg retrieval plan and agree to take highly effective contraceptive measures within 6 months after signing the informed consent to the last dose of study treatment. Male subjects who were not sterilized: did not plan to donate sperm and agreed to use highly effective contraception within 6 months after signing the informed consent form to the last dose of study therapy. 12. Subjects voluntarily participate in the study and have written informed consent signed by themselves or guardians or impartial witnesses (if applicable). The subject or his/her guardian is able to communicate well with the investigator, and the
Exclusion criteria
Exclusion criteria: 1. Previous recipients of Seleniso; 2. Subjects with acute or chronic GVHD who had received hematopoietic stem cell transplantation within 2 months before randomization or received anti-GVHD therapy due to graft-versa-host disease after hematopoietic stem cell transplantation during the screening period; 3. Subjects who received chemotherapy, targeted therapy, anti-tumor immunotherapy (immune checkpoint inhibitors, CAR-T therapy, etc.), radiotherapy, major surgery (excluding diagnostic surgery) within 4 weeks before randomization or =5 x drug half-life (if the drug half-life is specified, it is calculated as 5 times half-life, otherwise 4 weeks); 4. Those who received live vaccine (including attenuated live vaccine) within 4 weeks prior to randomization and/or planned to receive live vaccine after enrolling; 5. Participated in any interventional clinical trial and received the investigational drug or medical device intervention within the 4 weeks prior to randomization (except for participants who participated in the overall survival follow-up of a study); 6. Subjects diagnosed with acute promyelocytic leukemia; 7. The subjects had BCR-ABL positive leukemia (acute chronic myelogenous leukemia); 8. Malignant tumors other than AML in the 5 years prior to randomization, excluding: Tumors with a negligible risk of metastasis or death (e.g., expected 5-year OS > 90%) that are expected to be curable after treatment (e.g., cervical carcinoma in situ, skin basal cell or squamous cell carcinoma, localized prostate cancer treated with radical surgery, breast ductal carcinoma in situ treated with radical surgery, etc.), Or any other tumor that has been cured (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 ContactShukai Qiao
The Second Hospital of Hebei Medical University
Outcome results
None listed