blinatumomab prevents recurrence of r/r all after allo-hsct

Conditions: Leukemia, Lymphoid

Summary: the goal of this phase i/ii clinical trial is to test in relapsed or refractory acute lymphoblastic leukemia (r/r all) patients undergoing allogeneic hemopoietic stem-cell transplantation (allo-hsct). the main question it aims to answer is: • the efficacy and safety of blinatumomab maintenance therapy in reducing the recurrence rate a in r/r all patients after allo-hsct. participants will take intravenous blinatumomab after allo-hsct. the dose of one course was as follows: day 1-2: 8ug/day, continuous intravenous drip for 24 hours, day 3-7: 16ug/day, continuous intravenous drip for 24 hours. treatment with blinatumomab was initiated within 60 to 90 days after transplantation and was administered bimonthly until 1 year after transplantation. dexamethasone 20mg was administered 1 hour before administration on days 1 and 3 to prevent adverse events.


Eligibility criteria:
inclusion criteria: 1. b-all patients with history of relapse, or mrd positive in the last bone marrow examination before allo-hsct; 2. age ≥16 years old and ≤ 65 years old when signing informed consent form (icf); 3. kps \> 60 or ecog 0-2; 4. the expected survival time is more than 3 months; 5. complete remission (cr) after allo-hsct with either myeloablative or non-myeloablative conditioning regimen determined by the investigator; 6. 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; 7. no central nervous system involvement or clinical symptoms after transplantation; 8. those who have no serious functional damage to important organs of the body; 9. fully understand and be informed of this study and sign the icf; willing to follow and have the ability to complete all test procedures; 10. 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