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OpenTrials
Completed

NCT Number: NCT05390671

CAR-T Cell Therapy in Patients With Hematological Malignancies

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.

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Key information

Conditions

CART Therapy

Sex eligibility

All sexes

Study type

Observational

Primary location

Angel Cedillo

Madrid, Spain

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Progression free survival

    Time frame: 6 month

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

  2. Progression free survival

    Time frame: 12 month

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

  3. Progression free survival

    Time frame: 24 month

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

Secondary outcomes

  1. Overall survival

    Time frame: 6 month,12 month and 24 month

  2. High relevance toxicity rates

    Time frame: During the firs month

    Rate of grade 3 or more of CRS and neurotoxicity

  3. Progression free survival

    Time frame: 6 month,12 month and 24 month

    Patients who relapse or progress at 6, 12, 24 months from apheresis

Sponsors and collaborators

Lead sponsor

Grupo Espanol de trasplantes hematopoyeticos y terapia celular

Other

Registry information

Official study title

Retrospective Analysis of the Use of CAR-T Cell Therapy in Patients With Hematological Malignancies in Spain

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
May 25, 2022
Registry last updated
Jun 1, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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