CAR-T Cell Therapy in Patients With Hematological Malignancies

May 26, 2022 updated by: Grupo Espanol de trasplantes hematopoyeticos y terapia celular

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

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.

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

260

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Madrid, Spain
        • Angel Cedillo

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Other

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression free survival
Time Frame: 6 month
Patients who relapse or progress at 6 month after CART infussion.
6 month
Progression free survival
Time Frame: 12 month
Patients who relapse or progress at 12 month after CART infussion.
12 month
Progression free survival
Time Frame: 24 month
Patients who relapse or progress at 24 month after CART infussion.
24 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall survival
Time Frame: 6 month,12 month and 24 month
6 month,12 month and 24 month
High relevance toxicity rates
Time Frame: During the firs month
Rate of grade 3 or more of CRS and neurotoxicity
During the firs month
Progression free survival
Time Frame: 6 month,12 month and 24 month
Patients who relapse or progress at 6, 12, 24 months from apheresis
6 month,12 month and 24 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Grupo Espanol de trasplantes hematopoyeticos y terapia celular

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2020

Primary Completion (Actual)

January 1, 2021

Study Completion (Actual)

June 1, 2021

Study Registration Dates

First Submitted

April 27, 2022

First Submitted That Met QC Criteria

May 19, 2022

First Posted (Actual)

May 25, 2022

Study Record Updates

Last Update Posted (Actual)

June 1, 2022

Last Update Submitted That Met QC Criteria

May 26, 2022

Last Verified

May 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GETH-CART-2020-01

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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