Acute B lymphoblastic leukemia (ALL)
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patients newly diagnosed with B-ALL (bone marrow or peripheral blood blasts = 20%) according to WHO diagnostic criteria and confirmed by MICM testing, from January 2025 to December 2027; 2. Age 15–75 years; 3. Male or female; 4. Subjects treated with blinatumomab; 5. Patients fully understand and voluntarily provide written informed consent; 6. ECOG performance status score 0–3; 7. Expected survival time >= 3 months; 8. Liver function: total bilirubin = 30 mL/min; 10. Subjects provide informed consent for investigational therapy.
Exclusion criteria
Exclusion criteria: 1. T-cell acute lymphoblastic leukemia (T-ALL); 2. Minimal residual disease (MRD)-negative B-cell acute lymphoblastic leukemia (B-ALL); 3. Mature B-cell leukemia/lymphoma, B-lymphocytic lymphoma, or isolated extramedullary disease; 4. Acute mixed phenotype leukemia; 5. Complicated with central nervous system leukemia; 6. HIV infection, positive HBV-DNA, or positive HCV-RNA; 7. Patients with heart failure = Grade 2 and other patients considered ineligible by the investigator; 8. Female patients who are pregnant, lactating, or of childbearing potential without using effective contraception; 9. Patients with uncontrolled neurological or psychiatric disorders, mental disturbances, or cognitive impairment that may limit their ability to understand, comply with informed consent, and adhere to the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective Response Rate (ORR);MRD Clearance Rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression-Free Survival (PFS);Incidence of treatment-related severe infections (grade = 3) during induction therapy;Overall Survival (OS);Duration of myelosuppression;Event-Free Survival (EFS);Duration of Response (DOR); | — |
Countries
China
Contacts
Henan Cancer Hospital