CART Therapy
Conditions
Brief summary
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.
Detailed description
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).
Interventions
None listed
Sponsors
Grupo Espanol de trasplantes hematopoyeticos y terapia celular
Study design
Observational model
COHORT
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Adult patients \>18 y/o * Patients receiving CAR-T cell therapy in Spain, since 2018.
Exclusion criteria
T * Patients receiving CART therapy as part of a clinical trial.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Progression free survival | 6 month | Patients who relapse or progress at 6 month after CART infussion. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall survival | 6 month,12 month and 24 month | — |
| High relevance toxicity rates | During the firs month | Rate of grade 3 or more of CRS and neurotoxicity |
| Progression free survival | 6 month,12 month and 24 month | Patients who relapse or progress at 6, 12, 24 months from apheresis |
Countries
Spain
Outcome results
None listed