Acute B-lymphoblastic leukemia
Conditions
Interventions
Sponsors
The General Hospital of Western Theater Command
Eligibility
Sex/Gender
All
Age
14 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Patients diagnosed with acute B-lymphocyte leukemia; 2. Relapsed/refractory cases of acute B-lymphoblastic leukemia have poor response to conventional chemotherapy: (1) Patients who have not achieved complete remission after two courses of treatment with standard induced remission regimen; (2) Relapse within 6 months after the first remission; (3) Relapsed 6 months after the first remission, but the losers were treated again with the originally induced remission regimen; (4) Multiple recurrences; 3. No central nervous system leukemia; 4. At least 2 weeks or 5 half-lives (whichever is shorter) before the start of pretreatment chemotherapy, except for immune checkpoint inhibitors/agonists; Systemic immune checkpoint inhibitor/agonist treatment has at least 3 half-lives from pretreatment chemotherapy (e.g., ipilimumab, etc.); 5. The toxic reaction caused by previous anti-leukemia treatment must be stable and restored to = 3 months; 10. Adequate kidney, liver, lung and heart function, defined as: (1) Creatinine clearance (estimated by Cockcroft Gault formula) > 60 ml/min; (2) Serum ALT/AST = 50%, no pericardial effusion was determined by echocardiography, and no clinically significant abnormalities were found in ECG; (5) No pleural effusion with clinical significance; (6) Baseline oxygen saturation > 92% under indoor ventilation; 11. The serum pregnancy test results of women with fertility need to be negative (women who have undergone surgical sterilization or at least 2 years after menopause are considered to be infertile).
Exclusion criteria
Exclusion criteria: 1. The subject has suffered from other malignant tumors, nonmelanoma skin tumors, and carcinoma in situ (such as cervix, bladder and breast), unless the disease-free survival is at least 3 years; 2. Presence or suspicion of uncontrollable fungi, bacteria, viruses or other infections; 3. Known human immunodeficiency virus (HIV) infection; 4. Known history of hepatitis B (HBsAg positive) or hepatitis C (HCV antibody positive). Patients with concealed or hepatitis B infection (defined as HBcAb positive and HBsAg negative) should be enrolled in the case of negative PCR detection of HBV DNA. And these subjects need to carry out PCR detection of HBV DNA every month. HCV antibody seropositive subjects can also be included in the group if the PCR test result of HCV RNA is negative; 5. Existing or previous CNS diseases, such as seizures, cerebrovascular ischemia/hemorrhage, dementia, cerebellar diseases or any CNS-related autoimmune diseases; 6. Subjects with severe heart disease, such as uncontrolled or symptomatic arrhythmia, congestive heart failure or myocardial infarction within 6 months before screening, or any grade 3 (moderate) or 4 (severe) heart disease with cardiac function (according to the functional classification method NYHA of the New York Heart Association) and lymphoma infiltration in the heart atrium or ventricle; 7. Have a history of myocardial infarction, cardiac angioplasty or stent implantation, unstable angina pectoris or other clinically significant heart diseases within 12 months before enrollment; 8. Emergency treatment is expected or may occur due to rapid tumor progression within 6 weeks (such as tumor mass compression); 9. Primary immunodeficiency; 10. History of symptomatic deep venous thrombosis or pulmonary embolism within 6 months before enrollment; 11. Any medical condition that may affect the evaluation of safety or efficacy; 12. Have had severe immediate hypersensitivity to any drug to be used in this study; 13. Inoculate live vaccine <= 6 weeks before starting the pretreatment scheme; 14. Pregnant or lactating female subjects; 15. Male or female subjects who did not agree to effective contraception from the time of signing informed consent to 6 months after completing at19 treatment; 16. The subjects judged by the investigator are difficult to complete all visits or operations required by the study protocol (including follow-up visits), or their compliance to participate in the study is insufficient; 17. In the past two years, the subject has suffered from other malignant tumors, non melanoma skin tumors and carcinoma in situ (such as cervix, bladder and breast), unless the disease-free survival is at least 3 years; 18. Participants in other clinical trials at the same time.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Dose-limiting toxicity, DLT; | — |
Secondary
| Measure | Time frame |
|---|---|
| Complete response, CR; | — |
Countries
China
Contacts
Public ContactHai Yi
The General Hospital of Western Theater Command
Outcome results
None listed