CAR-T Cell Therapy in Patients With Hematological Malignancies
Study Details
Study Description
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.
Condition or Disease | Intervention/Treatment | Phase |
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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).
Study Design
Outcome Measures
Primary Outcome Measures
- Progression free survival [6 month]
Patients who relapse or progress at 6 month after CART infussion.
- Progression free survival [12 month]
Patients who relapse or progress at 12 month after CART infussion.
- Progression free survival [24 month]
Patients who relapse or progress at 24 month after CART infussion.
Secondary Outcome Measures
- 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
Eligibility Criteria
Criteria
Inclusion Criteria:
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Adult patients >18 y/o
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Patients receiving CAR-T cell therapy in Spain, since 2018.
Exclusion Criteria: T
- Patients receiving CART therapy as part of a clinical trial.
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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1 | Angel Cedillo | Madrid | Spain |
Sponsors and Collaborators
- Grupo Espanol de trasplantes hematopoyeticos y terapia celular
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- GETH-CART-2020-01