B-cell acute lymphoblastic leukemia (B-ALL)
Conditions
Interventions
Observational Group:None
Sponsors
Shanghai Children's Medical Center, Shanghai Jiao Tong University School of Medicine
Eligibility
Sex/Gender
All
Age
8 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Diagnosis: Previously diagnosed with B-cell acute lymphoblastic leukemia (B-ALL) and has received CAR-T therapy. 2. Treatment status: (1) CAR-T infusion has been completed for 6 months (+/- 3 months). (2) No hematopoietic stem cell transplant (allo-HSCT bridging) after CAR-T. 3. Age range: Age >= 8 years at the time of the study (to ensure the ability to complete neurocognitive tests). 4. Disease status: In complete remission (CR), with no active relapse or progression. 5. General condition: Stable vital signs, Karnofsky or Lansky score >= 70. 6. Language and comprehension ability: Possess basic communication and understanding skills to complete cognitive assessments and questionnaires. 7. Informed consent: Written informed consent signed by the patient and/or their guardian.
Exclusion criteria
Exclusion criteria: 1. Disease status: (1) Relapse or disease progression after CAR-T therapy. (2) Coexistence with other severe malignant tumors. 2. Influence of previous treatments: (1) Previous cranial radiotherapy. (2) Recent (within 6 months) high-dose chemotherapy or neurotoxic drug administration. 3. Nervous system diseases: (1) Previously diagnosed central nervous system diseases (such as epilepsy, brain tumor, severe craniocerebral trauma, etc.). (2) Presence of severe mental illness (such as schizophrenia, major depression) that affects test completion. 4. Other factors: (1) Coexisting severe heart, liver, or kidney dysfunction. (2) Inability to cooperate in completing CNS Vital Signs testing or functional MRI examination. (3) Other situations deemed unsuitable for enrollment by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clinical data;CNS-VS (Computerized Neurocognitive Assessment System);PROMs (Patient-Reported Outcome Measures);fMRI (functional magnetic resonance imaging) of brain; | — |
Countries
China
Contacts
Public ContactCai Jiaoyang
Shanghai Children's Medical Center, Shanghai Jiao Tong University School of Medicine
Outcome results
None listed