The prognosis of relapsed or refractory lymphoblastic leukaemia (ALL) and diffuse large B-cell lymphoma (DLBCL) is poor with conventional treatment with complete response rates around 25-30% with a median progression-free survival (PFS) of around 2 months and 7 months, respectively, despite the use of allogeneic and autologous haematopoietic stem cell transplantation. The recent introduction of CAR-T (Chimeric Antigen Receptor T-cells) therapy as a therapeutic option has been a breakthrough in the management of these entities.
Information on baseline patient characteristics, haematological disease, comorbidities and CAR-T therapy procedure (lymphodepletion schedule, infused product) will be collected. Early post-infusion toxicity and recurrence data will be collected. The grading of adverse effects will follow the EBMT and ASTCT guidelines. Finally, data will be collected to analyse survival and, in case of death, cause of death).
Study Type
OBSERVATIONAL
Enrollment
260
Angel Cedillo
Madrid, Spain
Progression free survival
Patients who relapse or progress at 6 month after CART infussion.
Time frame: 6 month
Progression free survival
Patients who relapse or progress at 12 month after CART infussion.
Time frame: 12 month
Progression free survival
Patients who relapse or progress at 24 month after CART infussion.
Time frame: 24 month
Overall survival
Time frame: 6 month,12 month and 24 month
High relevance toxicity rates
Rate of grade 3 or more of CRS and neurotoxicity
Time frame: During the firs month
Progression free survival
Patients who relapse or progress at 6, 12, 24 months from apheresis
Time frame: 6 month,12 month and 24 month
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