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Trial Title:
Determining the Mechanisms of Loss of CAR T Cell Persistence
NCT ID:
NCT05809284
Condition:
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
Conditions: Official terms:
Leukemia
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, Lymphoid
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
Summary:
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.
Criteria for eligibility:
Study pop:
The study population is paediatric and young adult patients aged 25 or younger who have
relapsed/refractory B-cell acute lymphoblastic leukaemia.
Sampling method:
Non-Probability Sample
Criteria:
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
Gender:
All
Minimum age:
N/A
Maximum age:
25 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Great Ormond Street Hospital
Address:
City:
London
Country:
United Kingdom
Status:
Recruiting
Contact:
Last name:
Persis Amrolia
Investigator:
Last name:
Persis Amrolia
Email:
Principal Investigator
Facility:
Name:
University College London Hospital
Address:
City:
London
Country:
United Kingdom
Status:
Recruiting
Contact:
Last name:
Rachael Hough
Investigator:
Last name:
Rachael Hough
Email:
Principal Investigator
Facility:
Name:
Royal Manchester Children's Hospital
Address:
City:
Manchester
Country:
United Kingdom
Status:
Recruiting
Contact:
Last name:
Denise Bonney
Investigator:
Last name:
Denise Bonney
Email:
Principal Investigator
Start date:
October 18, 2023
Completion date:
December 1, 2025
Lead sponsor:
Agency:
University College, London
Agency class:
Other
Source:
University College, London
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05809284
