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Recruiting NCT05809284

Determining the Mechanisms of Loss of CAR T Cell Persistence

— Observational Acute Lymphoblastic Leukemia With Failed Remission Acute Lymphoblastic Leukemia Not Having Achieved Remission Acute Lymphoblastic Leukemia, Pediatric Acute Lymphoblastic Leukemia, Adult

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Acute Lymphoblastic Leukemia With Failed Remission, Acute Lymphoblastic Leukemia Not Having Achieved Remission, Acute Lymphoblastic Leukemia, Pediatric, Acute Lymphoblastic Leukemia, Adult. Basic parameters: up to 25 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United Kingdom
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

A prospective observational study of pediatric and young adult acute lymphoblastic leukaemia (ALL) patients treated with CD19 chimeric antigen receptor T-cells (CAR-T cells). The study will examine changes in CAR-T persistence over time and causal factors.

Primary outcome measures

  • Time to circulating CAR-T cell loss [Time frame: Through study completion, until the last patient reaches 1 year post-infusion]

Eligibility criteria

Inclusion criteria

  • Children and young adults (age 25 years or younger) with relapsed/refractory ALL who are planned to receive licensed CD19-targeted CAR-T cell treatment (Tisagenlecleucel)
  • Written informed consent

Exclusion criteria

  • Patients receiving an alternate CD19-directed CAR T-cell product on a clinical trial
  • Any reason that in the opinion of the investigator, patients won't be able to adhere to the protocol

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

United Kingdom · 3 centers
  • Great Ormond Street Hospital — London
  • University College London Hospital — London
  • Royal Manchester Children's Hospital — Manchester

Identifiers

NCT: NCT05809284 · UCL/156503

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗