CAR-T Cell Therapy in Patients With Hematological Malignancies
- Conditions
- CART Therapy
- Registration Number
- NCT05390671
- Lead Sponsor
- Grupo Espanol de trasplantes hematopoyeticos y terapia celular
- 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).
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 260
- Adult patients >18 y/o
- Patients receiving CAR-T cell therapy in Spain, since 2018.
T
- Patients receiving CART therapy as part of a clinical trial.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Progression free survival 24 month Patients who relapse or progress at 24 month after CART infussion.
- Secondary Outcome Measures
Name Time Method Overall survival 6 month,12 month and 24 month Progression free survival 6 month,12 month and 24 month Patients who relapse or progress at 6, 12, 24 months from apheresis
High relevance toxicity rates During the firs month Rate of grade 3 or more of CRS and neurotoxicity
Trial Locations
- Locations (1)
Angel Cedillo
🇪🇸Madrid, Spain