Relapse/refractory T-lineage acute lymphoblastic leukemia and lymphoma
Conditions
Interventions
Sponsors
Shanghai Children's Medical Center Affiliated to School of Medicine, Shanghai Jiaotong University
Eligibility
Sex/Gender
All
Age
No minimum to 35 Years
Inclusion criteria
Inclusion criteria: Patients with disease onset at age < 35 years, with confirmed presence of experimentally validated targets such as CD7, CD99, CD1a, CCR9, etc. Patients must meet at least one of the following criteria: 1. Newly diagnosed patients confirmed as meeting the standard definition of refractoriness for T-lineage malignancies following chemotherapy. 2. Newly diagnosed patients with disease progression during chemotherapy, indicating poor anticipated chemotherapy response. 3. Patients with one or multiple relapses, supported by clear evidence of residual tumor. 4. Patients with disease relapse after autologous or allogeneic hematopoietic stem cell transplantation (HSCT). 5. Patients who are not candidates for cure with current modalities including surgery, radiotherapy, or chemotherapy.
Exclusion criteria
Exclusion criteria: Patients meeting any of the following criteria will be excluded from participation in this study: 1. Age at disease onset > 35 years; 2. Expected survival period 2.5 mg/dL; ALT/AST > 5× upper limit of normal (ULN); total bilirubin > 2 mg/dL. 7. Presence of uncontrolled active infection. 8. Active hepatitis B or C, or HIV infection. 9. Lost to follow-up within < 3 months after treatment. 10. Failure to provide informed consent or without approval from the Ethics Committee. 11. Presence of other systemic diseases that may interfere with the study. 12. Any other condition deemed by the investigator as grounds for exclusion.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cytotoxicity;MRD; | — |
Secondary
| Measure | Time frame |
|---|---|
| CAR-T cell expansion and persistence; | — |
Countries
China
Contacts
Public ContactBenshang Li
Shanghai Children's Medical Center Affiliated to School of Medicine, Shanghai Jiaotong University
Outcome results
None listed