A Multicenter Study to Evaluate Next-Generation Sequencing (NGS) Testing and Monitoring of B-Cell… (NCT05621291) | Clinical Trial Compass
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A Multicenter Study to Evaluate Next-Generation Sequencing (NGS) Testing and Monitoring of B-Cell Recovery to Guide Management Following Chimeric Antigen Receptor T-cell (CART) Induced Remission in Children and Young Adults With B Lineage Acute Lymph...
United States60 participantsStarted 2026-08-18
Plain-language summary
Background:
Chimeric antigen receptor T-cell (CART) therapy is a form of immunotherapy which can be used to treat people with relapsed B-ALL. For those who achieve remission after CART alone, it may cure up to 50% of people who receive this therapy. However, for people who relapse after CART, it can be hard to achieve remission again. In patients where CART fails, stem cell transplant (HCT) can be used to prevent relapse and achieve cure. But HCT can cause serious side effects. Better testing is needed to distinguish people who can be cured with CART alone from people who may also need to have HCT.
Objective:
To see if the use of a series of blood and bone marrow tests at regular intervals can help monitor for B-ALL relapse after CART therapy.
Eligibility:
People aged 1 to 25 years with B-ALL who have had CART therapy within the past 42 days. They must never have had a blood stem cell transplant; they must also have no measurable blood cancer cells.
Design:
Participants will visit the clinic every 2 weeks starting 42 days after they receive CART therapy. Each visit will be about the same amount of time as a regular clinic visit. about 8 hours.
Participants will have blood drawn for testing on each visit.
Bone marrow biopsy/aspirate will be done during 4 of the visits at routine timepoints after CART. A needle will be inserted to draw a sample of tissue from inside the bone in the hip.
A small amount of blood and tissue will be tested with ClonoSEQ and to evaluate for normal B-cells side by side with the standard tests.
The combined testing may help determine whether participants are eligible for HCT and/or at risk of relapse after CART.
Participants will be in the study for 2 years.
Who can participate
Age range
1 Year – 25 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
-Have an informative NGS clonality sample for MRD assessment based on immunoglobulin rearrangement in bone marrow or blood at any time of active disease between diagnosis and CD19 CART infusion and any time prior to the first on-study intervention confirmed by NGS MRD testing.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Since this trial uses next-generation sequencing (NGS) testing to monitor remission after CAR T-cell therapy, can you explain how that type of monitoring differs from what we'd be doing outside the trial, and whether it might catch a relapse earlier?
2This study is listed as Phase NA, which suggests it may be more focused on measuring and observing outcomes than on testing a new treatment — does that mean my child's core treatment plan wouldn't change if we enrolled, and what exactly would be different day-to-day?
3The trial is specifically for children and young adults with B-cell ALL who are already in remission after CAR T-cell therapy — can you help me understand whether my child's current situation matches what this study is looking for, and whether now is the right timing to consider it?
4What does 'B-cell recovery monitoring' mean in practice for this trial, and how often would my child need additional blood draws, tests, or clinic visits beyond what's already scheduled?
5If we don't join this trial, what is the standard approach for monitoring remission and deciding on next steps after CAR T-cell therapy, and how does that compare to what this biomarker-guided strategy is trying to improve on?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Efficacy of novel biomarker-guided risk based strategy to monitor remission
Timeframe: baseline to 1 year post CD19 CART infusion