NCT05390671

CAR-T Cell Therapy in Patients With Hematological Malignancies

Retrospective Analysis of the Use of CAR-T Cell Therapy in Patients With Hematological Malignancies in Spain

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 260 (actual)
• Sponsor: Grupo Espanol de trasplantes hematopoyeticos y terapia celular · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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).

Conditions

• CART Therapy

Timeline

• Start date: 2020-11-01
• Primary completion: 2021-01-01
• Completion: 2021-06-01
• First posted: 2022-05-25
• Last updated: 2022-06-01

Locations

1 site across 1 country: Spain