An observational study in CART Therapy, sponsored by Grupo Espanol de trasplantes hematopoyeticos y terapia celular. Completed at 1 site in Spain. Per ClinicalTrials.gov, last updated 2022-06-01.
Sponsored by Grupo Espanol de trasplantes hematopoyeticos y terapia celular · Observational
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.
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).
1,464 studies on the registry are indexed under Hematologic Neoplasms; 433 are open to participants now.
This study's enrollment of 260 is above the median of 186 across 326 observational studies indexed under Hematologic Neoplasms.
Browse Hematologic Neoplasms studies →Grupo Espanol de trasplantes hematopoyeticos y terapia celular is the lead sponsor of 9 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Adult patients >18, with hematologic malignancies (lymphoma, leukemia, myeloma) in which the use of CAR-T therapy is approved, undergoing CAR-T therapy in Spain.
Inclusion Criteria:
Exclusion Criteria: T
Progression free survival
Patients who relapse or progress at 6 month after CART infussion.
Time frame: 6 month
Progression free survival
Patients who relapse or progress at 12 month after CART infussion.
Time frame: 12 month
Progression free survival
Patients who relapse or progress at 24 month after CART infussion.
Time frame: 24 month
Overall survival
Time frame: 6 month,12 month and 24 month
High relevance toxicity rates
Rate of grade 3 or more of CRS and neurotoxicity
Time frame: During the firs month
Progression free survival
Patients who relapse or progress at 6, 12, 24 months from apheresis
Time frame: 6 month,12 month and 24 month
This study is completed, as verified in May 2022. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Grupo Espanol de trasplantes hematopoyeticos y terapia celular