prospective, single-arm, multicenter clinical study on haploidentical hematopoietic stem cell transplantation in patients with mrd positive cd19+all treated with conditioning regimens containing blinatumomab

Conditions: Acute Lymphoblastic Leukemia

Summary: a study on the effectiveness and safety of haploidentical hematopoietic stem cell transplantation in patients with mrd positive cd19+ all treated with conditioning regimens containing blinatumomab

this is a prospective multicenter clinical study. this study is applicable to cd19+ all patients undergoing allogeneic hematopoietic stem cell transplantation. the purpose is to evaluate the effectiveness and safety of haploidentical hematopoietic stem cell transplantation in patients with mrd positive cd19+ all treated with conditioning regimens containing blinatumomab.31 patients will be included in the study. clinical endpoints include progress-free survival, overall survival, cumulative incidence of relapse, non-relapse mortality, minimal residual disease, and graft versus host disease.

Eligibility criteria:
inclusion criteria: 1. diagnosed as acute b-all with cd19+ according to the 2022 who classification criteria. after induction and intensified chemotherapy, complete hematological remission was achieved, but mrd was positive by flow cytometry; 2. age range from 18 to 70 years old, regardless of gender; 3. the eastern oncology collaborative group (ecog) physical fitness score is 0-2 points; 4. female patients of childbearing age who had a negative pregnancy test before the trial and agreed to take effective contraceptive measures during the trial until their last visit; 5. organ function is normal, and the following laboratory indicators are met within one week of enrollment: creatinine clearance rate ≥ 60 ml/min (according to the cockcroft fault formula); ast and alt ≤ 3 × upper limit of normal value range (uln), total bilirubin ≤ 2 × uln; echocardiography (echo) shows left ventricular ejection fraction (lvef) ≥ 50%; 6. life expectancy greater than 8 weeks; 7. voluntarily sign an informed consent form to understand and comply with the requirements of the study. exclusion criteria: 1. failure to achieve complete hematological remission, including residual extramedullary infiltration; 2. previously received hematopoietic stem cell transplantation; 3. received systemic chemotherapy within 2 weeks; 4. previously received treatment with blinatumomab; 5. have a history of central nervous system leukemia or present with central nervous system leukemia; 6. active autoimmune diseases, such as sle, rheumatoid arthritis, etc; 7. currently suffering from clinically significant active cardiovascular diseases, such as uncontrolled arrhythmia, uncontrolled hypertension, congestive heart failure, any grade 3 or 4 heart disease determined according to the new york heart association (nyha) functional classification (see appendix 1), or having a history of myocardial infarction within 6 months prior to screening; 8. chronic obstructive pulmonary disease with whole lung dysfunction; 9. other serious diseases that may restrict patients from participating in this test (such as advanced infection, uncontrollable diabetes); 10. concomitant arteriovenous thrombosis or hypercoagulable state; 11. known human immunodeficiency virus (hiv) infection, or chronic infection of hepatitis b virus (hbsag positive) or hepatitis c virus (anti-hcv positive) beyond drug control; 12. pregnant or lactating women; 13. severe allergies to other monoclonal antibodies in the past; 14. those who are unable to understand, comply with the research protocol or sign an informed consent form.

Keywords: minimal residual disease allogeneic hematopoietic stem cell transplantation blinatumomab