CAR-T Cell Therapy in Patients With Hematological Malignancies

Grupo Espanol de trasplantes hematopoyeticos y terapia celular

Status: Completed

Conditions: CART Therapy

Study type: Observational

Funder types: Other

Identifiers

NCT05390671

GETH-CART-2020-01

Details and patient eligibility

About

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.

Full 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).

Enrollment: 260 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.