Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-26 @ 1:18 PM
Ignite Modification Date:
2025-12-26 @ 1:18 PM
NCT ID:
NCT06125106
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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT06125106
Study Brief:
Protocol Section:
NCT06125106