Acute Lymphoblastic Leukemia With Failed RemissionCARPERSNCT05809284
Determining the Mechanisms of Loss of CAR T Cell Persistence
An observational study of Acute Lymphoblastic Leukemia With Failed Remission and Acute Lymphoblastic Leukemia Not Having Achieved Remission, run by University College, London at 3 sites in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 25 years
- Conditions the study is for
- Acute Lymphoblastic Leukemia With Failed Remission, Acute Lymphoblastic Leukemia Not Having Achieved Remission, Acute Lymphoblastic Leukemia, Pediatric
- How many people
- 50 participants
- Where
- 3 sitesUnited Kingdom
- Study dates
- 18 Oct 2023to 1 Jul 2027
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 25 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: The study population is paediatric and young adult patients aged 25 or younger who have relapsed/refractory B-cell acute lymphoblastic leukaemia.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom3 sites, 3 recruiting
- Recruiting
Great Ormond Street Hospital
London
Persis Amrolia
Persis Amrolia
- Recruiting
University College London Hospital
London
Rachael Hough
Rachael Hough
- Recruiting
Royal Manchester Children's Hospital
Manchester
Denise Bonney
Denise Bonney
About this study
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.
- Conditions
- 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
- Medical subject headings
- Precursor Cell Lymphoblastic Leukemia-Lymphoma
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to circulating CAR-T cell loss
CAR-T persistence will be measured in the central lab from blood samples.
Measured: Through study completion, until the last patient reaches 1 year post-infusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2023
- Study start18 Oct 2023
- Primary completion1 Jul 2027 (estimated)
- Study completion1 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Lymphoblastic Leukemia With Failed RemissionStudies of the same condition, open and under way.
- More trials run by University College, LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University College, London
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Persis Amrolia, BSc,MBBS,PhD, Study chair, UCL Institute of Child Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05809284
- Sponsor's protocol ID
- UCL/156503
- Acronym
- CARPERS
- Status last verified
- Aug 2026
- First submitted
- 3 Mar 2023
- Last updated
- 7 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No