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
- Are there results?
- Not yet: the study is under way
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
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determining the Mechanisms of Loss of CAR T Cell Persistence
- ClinicalTrials.gov ID
- NCT05809284
- Acronym / sponsor ID
- CARPERS / UCL/156503
- 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
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University College, LondonUniversity, hospital or other
- Study start
- 18 Oct 2023 (actual)
- Primary completion
- 1 Jul 2027 (estimated)
- Study completion
- 1 Jul 2027 (estimated)
- First posted
- 12 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- Up to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- 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.
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Time to circulating CAR-T cell loss
Time frame: Through study completion, until the last patient reaches 1 year post-infusion
CAR-T persistence will be measured in the central lab from blood samples.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Persis Amrolia, BSc,MBBS,PhD study chair
UCL Institute of Child Health
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
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.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 7 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact CARPERS Trial Manager (442031084189, ctc.carpers@ucl.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to circulating CAR-T cell loss (time frame: Through study completion, until the last patient reaches 1 year post-infusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2026.