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Long-Term Health After CAR T-cell Therapy for B-ALL

This observational study aims to understand the long-term health of children, adolescents, and young adults (AYA) who have been treated for B-Cell Acute Lymphoblastic Leukemia (B-ALL) with CD19-CAR T-cell therapy. Researchers want to see if it's possible to consistently assess how these patients are doing years after their treatment. The study will look at health conditions that develop two or more years after receiving CD19-CAR T-cells. You might be able to join if you are 26 years old or younger at the time of your first CAR T-cell treatment for B-ALL, received a CD19-containing CAR T-cell product, and are in sustained remission. The study is currently recruiting participants.

Study design
This is an observational study with a planned enrollment of 80 participants. It is not a treatment study but rather focuses on understanding long-term health outcomes.
What's involved
Eligible participants will undergo a comprehensive health assessment, including a physical exam, lab tests, a brain MRI, physical performance tests, and neurocognitive tests.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed through study completion, which is approximately 5 years.

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NCT07048535

CAR T-cell Long-Term Follow-Up, Quality of Life and Adverse Reactions

Recruiting
Not specifiedAll AgesObservational
St. Jude Children's Research Hospital
~80 participants
Updated 2026-04-29 on ClinicalTrials.gov

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
To evaluate the feasibility of conducting standardized clinical assessments of pediatric and AYA B-ALL survivors post CD19-CAR T-cell therapy
Measured over Through study completion, approximately 5 years

Conditions

B-Cell Acute Lymphoblastic Leukemia (B-ALL)

Explore related trials

B Acute Lymphoblastic Leukemia

Where it's being run

1 sites across 1 states
Tennessee1

Study leadership

  • Aimee Talleur, MD · PRINCIPAL_INVESTIGATOR · St. Jude Children's Research Hospital

Who to contact

Aimee Talleur, MD
[email protected]
888-226-4343
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

≤ 26-years old at the time of the first CAR treatment
Receipt of a CD19-containing CAR T-cell product (investigational or commercial) for B- ALL
Receipt of one unique CAR product (reinfusion of same product allowed)
Sustained remission without subsequent therapy post-CAR (exception= post-CAR consolidative HCT)
Receipt of only one prior HCT (inclusive of pre- or post-CAR)
≥ 2-years post last CAR T-cell infusion

Exclusion

Inability or unwillingness of research participant or legal guardian/representative to give written informed consent

What this trial measures

  • To evaluate the feasibility of conducting standardized clinical assessments of pediatric and AYA B-ALL survivors post CD19-CAR T-cell therapyThrough study completion, approximately 5 years

    Estimation of participation rate