CAR-T Cell Therapy in Patients With Hematological Malignancies

Sponsor
Grupo Espanol de trasplantes hematopoyeticos y terapia celular (Other)
Overall Status
Completed
CT.gov ID
NCT05390671
Collaborator
(none)
260
1
7
37.3

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

    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

    Study Type:
    Observational [Patient Registry]
    Actual Enrollment :
    260 participants
    Observational Model:
    Cohort
    Time Perspective:
    Other
    Official Title:
    Retrospective Analysis of the Use of CAR-T Cell Therapy in Patients With Hematological Malignancies in Spain
    Actual Study Start Date :
    Nov 1, 2020
    Actual Primary Completion Date :
    Jan 1, 2021
    Actual Study Completion Date :
    Jun 1, 2021

    Outcome Measures

    Primary Outcome Measures

    1. Progression free survival [6 month]

      Patients who relapse or progress at 6 month after CART infussion.

    2. Progression free survival [12 month]

      Patients who relapse or progress at 12 month after CART infussion.

    3. Progression free survival [24 month]

      Patients who relapse or progress at 24 month after CART infussion.

    Secondary Outcome Measures

    1. Overall survival [6 month,12 month and 24 month]

    2. High relevance toxicity rates [During the firs month]

      Rate of grade 3 or more of CRS and neurotoxicity

    3. 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

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Adult patients >18 y/o

    • 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
    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.
    Responsible Party:
    Grupo Espanol de trasplantes hematopoyeticos y terapia celular
    ClinicalTrials.gov Identifier:
    NCT05390671
    Other Study ID Numbers:
    • GETH-CART-2020-01
    First Posted:
    May 25, 2022
    Last Update Posted:
    Jun 1, 2022
    Last Verified:
    May 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jun 1, 2022