IRB Study Number 22-728
Status Recruiting
Institutes Taussig Cancer Institute, Pediatric Institute
Description
Primary Objective
To estimate incidence of neuropsychomotor developmental impairment, endocrine impairment, neurological impairment, and immune system impairment (including auto-immune disorders and vaccine failure)
Secondary Objectives
To estimate the incidence of allogeneic Haemopoietic Stem Cell Transplant (alloHSCT) related adverse events
To estimate the incidence of subsequent relapse of leukemia including in the central nervous system (CNS)
To estimate the cumulative incidence of long-term adverse events collected in this study
To estimate the incidence of secondary malignant formation
To estimate overall survival
Inclusion Criteria
Paediatric ( 18 years old) B-cell precursor ALL patients with any indication worldwide that received blinatumomab or chemotherapy in routine clinical practice, followed by transplantation, or EU paediatric indications that may be authorized in the future. This means that paediatric patients which receive blinatumomab off-label in the EU or with a different indication in ex-EU regions may be included in the study. Only patients whose medical charts are available for review from the HSCT will be enrolled in the study.
Patient’s legally acceptable representative has provided informed consent when the patient is legally too young to provide informed consent and the patient has provided written assent based on local regulations and/or guidelines prior to any study-specific activities/procedures being initiated.
Exclusion Criteria
Patients who have received CAR-T prior to study enrolment will be not eligible for this study.
