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:
2025-12-24 @ 4:51 PM
Ignite Modification Date:
2025-12-24 @ 4:51 PM
NCT ID:
NCT05559450
Eligibility Criteria:
Inclusion Criteria:
1. The patients meet the diagnostic criteria for high risk precursor B-ALL (according to the 2016 WHO classification) and are under hematologic remission.
2. ECOG score is 0-2.
3. Expecting life span is more than 6 months.
4. Patients are free from severe organ dysfunction.
Exclusion Criteria:
1. Patients are combined with severe organ dysfunction: Organ failure: Cardiac failure: ejection fraction(EF) \<30%, NYHA standard, cardiac function not Full Grade II or above; Liver and kidney insufficiency: serum total bile Erythroid ≥2mg/dl, AST or ALT≥ upper limit of normal 2.5-fold, serum creatinine (SCr) \>2.5mg/ dL or blood Creatinine clearance rate \< 30ml/min.
2. Patients are combined with infection or other complications that can not tolerate chemotherapy.
3. Patients are suffering from central nervous system/solitary extramedullary leukemia.
4. Patients are considered as tumer progression.
5. Patients has undergone allogeneic hematopoietic stem cell transplantation or underwent autologous stem cell transplantation within 6 weeks or other immunotherapy within 4 weeks.
6. Pregnant and lactating women will not be included.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
14 Years
Maximum Age:
65 Years
Study:
NCT05559450
Study Brief:
Protocol Section:
NCT05559450