Relapsed/refractory acute myeloid leukaemia and relapsed/refractory acute lymphoblastic leukaemia Cancer
Conditions
Interventions
This study is a long-term observational follow-up of patients who received allo-CAR Investigational Medicinal Products (IMPs) after allogeneic stem cell transplantation (allo-SCT). The study aims to a
Sponsors
Great Ormond Street Hospital for Children NHS Foundation Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: The principal inclusion criteria are: 1. Written informed consent obtained prior to any study-specific procedure (patient or parent(s) or legal representative) 2. Patients affected by advanced lymphoid or myeloid leukemia, who have been administered with allogenic genome edited lentiviral CAR T cells and had allo-SCT over 12 months ago
Exclusion criteria
Exclusion criteria: Not meeting the inclusion criteria
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The identification and documentation of long-term adverse effects following genome-edited allogeneic universal CAR T cell therapy and allogeneic transplant (PBLTT52CAR19, BE-CAR7, and BE-CAR33), including non-persistence of IMP beyond allo-SCT (via chimerism testing), the occurrence of new haematologic disorders (cytopenia, malignancies), autoimmune disorders, immune recovery (T-cell, B-cell aplasia, immunoglobulins), severe viral infections, engraftment, chimerism status, and new or ongoing GVHD grade 3 or higher, assessed annually from year 2 or 3 through year 15 (+/- 1 month) | — |
Secondary
| Measure | Time frame |
|---|---|
| The tracking of mononuclear cell chimerism for the recipient, transplant donor, and IMP (CAR-T) donor signals to confirm the non-persistence of IMP (by chimerism assay). Chimerism status in blood will be performed annually from year 2 or 3 through year 15 (+/- 1 month) | — |
Countries
United Kingdom
Contacts
Public ContactAgnieszka Kubat
Outcome results
None listed