CAR-T Cell Therapy in Patients With Hematological Malignancies

NCT ID: NCT05390671

Last Updated: 2022-06-01

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 260 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-11-01
• Study Completion Date: 2021-06-01

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).

Conditions

CART Therapy

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: OTHER

Eligibility Criteria

Inclusion Criteria

• Adult patients >18 y/o
• Patients receiving CAR-T cell therapy in Spain, since 2018.

Exclusion Criteria

• Patients receiving CART therapy as part of a clinical trial.

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Grupo Espanol de trasplantes hematopoyeticos y terapia celular

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Angel Cedillo

Madrid, , Spain

Countries

Spain

Other Identifiers

GETH-CART-2020-01

Identifier Type: -

Identifier Source: org_study_id