Determining the Mechanisms of Loss of CAR T Cell Persistence

NCT ID: NCT05809284

Last Updated: 2024-05-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-10-18

Study Completion Date

2025-12-01

Brief Summary

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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.

Detailed Description

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Conditions

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Acute Lymphoblastic Leukemia With Failed Remission Acute Lymphoblastic Leukemia Not Having Achieved Remission Acute Lymphoblastic Leukemia, Pediatric Acute Lymphoblastic Leukemia, Adult Acute Lymphoblastic Leukemia, in Relapse

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

1. 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)
2. Written informed consent

Exclusion Criteria

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

25 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University College, London

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Persis Amrolia, BSc,MBBS,PhD

Role: STUDY_CHAIR

UCL Institute of Child Health

Locations

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Great Ormond Street Hospital

London, , United Kingdom

Site Status RECRUITING

University College London Hospital

London, , United Kingdom

Site Status RECRUITING

Royal Manchester Children's Hospital

Manchester, , United Kingdom

Site Status RECRUITING

Countries

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United Kingdom

Central Contacts

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CARPERS Trial Manager

Role: CONTACT

442031084189

Facility Contacts

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Persis Amrolia

Role: primary

Rachael Hough

Role: primary

Denise Bonney

Role: primary

Other Identifiers

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UCL/156503

Identifier Type: -

Identifier Source: org_study_id

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