Relapsed/ Refactory Leukemian
Conditions
Interventions
Case series:In vitro T cell depletion
Sponsors
Shanghai Children's Medical Center
Eligibility
Sex/Gender
All
Age
0.2 Years to 18 Years
Inclusion criteria
Inclusion criteria: Pediatric patients with hematological malignancies in complete remission (CR), partial remission (PR) or with stable disease 1. Acute myeloid leukemia (AML): Patients with high-risk AML in CR1; Patients with relapsed or primary therapy-refractory AML; 2.Acute lymphoid leukemia (ALL): Patients with high-risk ALL in CR1; Patients with relapsed or primary refractory ALL.
Exclusion criteria
Exclusion criteria: 1. Age >18 years or 2 mg/dL and elevation of transaminases higher than 400 U/L; 7. Chronic active viral hepatitis; 8. Ejection fraction grade II hypertension by Common Toxicity Criteria (CTC); 10. Creatinine clearance below threshold defined for stem cell transplantation according to local clinical standard; 11. Respiratory failure necessitating supplemental oxygen; 12. HIV infection; 13. Concurrent severe or uncontrolled medical disease (e.g. uncontrolled diabetes, congestive heart failure, myocardial infarction within 6 months prior to the study, unstable and uncontrolled hypertension, chronic renal disease, or active uncontrolled infection) which by assessment of the treating physician could compromise participation in the study; 14. Patients with a history of psychiatric illness or a condition which could interfere with their ability to understand the requirements of the study (this includes alcoholism/drug addiction); 15. Patients unwilling or unable to comply with the protocol or unable to give informed consent; 16. Treatment with any investigational product within 4 weeks prior to study treatment (transfusion of the IMP).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Rate of acute GVHD;Over all survival;Leukemia Free survival;Rate of Grade III-IV GVHD; | — |
Countries
China
Contacts
Public ContactChen Jing
Shanghai Children's Medical Center
Outcome results
None listed