Refractory/Relapsed acute myeloid leukemia in Children
Conditions
Interventions
Sponsors
Shanghai Children's Medical Center, Shanghai Jiao Tong University School of Medicine
Eligibility
Sex/Gender
All
Age
No minimum to 18 Years
Inclusion criteria
Inclusion criteria: 1.Patients with disease onset at age < 18 years, with confirmed presence of experimentally validated targets (e.g., CD123, CD33, CD38, CD70, CLL1, EGFRvIII, GRP78, TIM-3). Patients must meet at least one of the following criteria:; 2.Newly diagnosed patients meeting the standard definition of refractory AML following chemotherapy. 3.Newly diagnosed patients with disease progression during chemotherapy, indicating poor anticipated treatment response. 4.Patients with one or multiple relapses, supported by definitive evidence of residual disease. 5.Patients with disease relapse after autologous or allogeneic hematopoietic stem cell transplantation (HSCT). 6.Patients who are not candidates for cure with current therapeutic modalities (including surgery, radiotherapy, or chemotherapy).
Exclusion criteria
Exclusion criteria: 1. Patients meeting any of the following criteria will be excluded from study participation; 2. Age at disease onset >18 years old; 3. Expected survival 2.5 mg/dL; ALT/AST >5× upper limit of normal (ULN); Total bilirubin >2 mg/dL; 8. Uncontrolled active infection; 9. Active hepatitis B/C or HIV infection; 10. Lost to follow-up within 3 months post-treatment; 11. Failure to provide informed consent or lack of Ethics Committee approval; 12. Concurrent systemic conditions that may interfere with study objectives; 13. Any other condition deemed ineligible by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| CAR-T cell expansion and persistence;MRD;Cytokines; | — |
Countries
China
Contacts
Public ContactLi Benshang
Shanghai Children's Medical Center, Shanghai Jiao Tong University School of Medicine
Outcome results
None listed