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RecruitingNCT07048535Updated Apr 29, 2026

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

An observational study in B-Cell Acute Lymphoblastic Leukemia (B-ALL), sponsored by St. Jude Children's Research Hospital. Recruiting at 1 site in United States. Per ClinicalTrials.gov, last updated 2026-04-29.

Sponsored by St. Jude Children's Research Hospital · Observational

From the registry’s dates

  • Started Oct 2025; still recruiting 11 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
80
Sex
All
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Study summary

To learn more about the long-term health in patients treated for B-Cell Acute Lymphoblastic Leukemia (B-ALL) with Cluster of Differentiation antigen 19 (CD19)

-redirected chimeric antigen receptor (CAR) T-cells.

Primary Objective:

To evaluate the feasibility of conducting standardized clinical assessments of pediatric, adolescent and young adult (AYA) B-ALL survivors post CD19-CAR T-cell therapy, treated at multiple institutions, leveraging the St Jude Lifetime Cohort (SJLIFE) clinical and research infrastructure.

Exploratory Objectives:

  • To describe the prevalence of persistent and new/late-onset health conditions developing ≥2-years post CD19-CAR T-cell therapy in survivors of pediatric and AYA B-ALL.
  • To characterize neurocognitive and neurologic function in survivors ≥2-years post CD19- CAR T-cell therapy.
  • To characterize immune health in survivors ≥2-years post CD19-CAR T-cell therapy.
  • To characterize functional status in survivors ≥2-years post CD19-CAR T-cell therapy.
Read the detailed description

Advances in cancer immunotherapies, including CD19-redirected chimeric antigen receptor (CAR) T-cells, are changing the long-term outcome for B-ALL cancer patients.

The late effects of these treatments have not been investigated and the impact of this therapy on survivors' long-term outcomes and overall well-being is unknown.

The purpose of this study is to determine the feasibility of studying late effects following CAR T-cell therapy through a prospective, observational study for children, adolescent, and young adult (AYA) survivors who are ≥2-years post CD19-CAR T-cell infusion. The study will be the first study of late effects following CAR T-cell therapy recruiting B-ALL survivors from across the United States.

Eligible study participants will participate in a comprehensive health assessment. These assessments will include history and physical examination, laboratory studies, a brain MRI, physical performance testing, and neurocognitive testing. The CONQUER study will focus specific attention on data relevant to CD19-CAR T-cell therapy, including immune function.

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Conditions studied

  • B-Cell Acute Lymphoblastic Leukemia (B-ALL)

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Keywords

  • B-Cell Acute Lymphoblastic Leukemia
  • B-ALL
  • Survivorship
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In context

Burkitt Lymphoma

392 studies on the registry are indexed under Burkitt Lymphoma; 114 are open to participants now.

This study's planned enrollment of 80 is below the median of 300 across 25 observational studies indexed under Burkitt Lymphoma.

Browse Burkitt Lymphoma studies →

Lead sponsor

St. Jude Children's Research Hospital is the lead sponsor of 434 studies on the registry; 99 are open to participants now.

Of its 60 completed or terminated interventional studies of FDA-regulated products, 35 (58%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

All participants who meet eligibility criteria and consent to enrollment on the study.

Inclusion criteria

  • ≤ 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 criteria

Exclusion Criteria:

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

Observational model
Cohort
Time perspective
Prospective
Enrollment
80 participants (estimated)
Patient registry
No
Biospecimen retention
Samples with dna
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What researchers measure

Primary outcomes

  1. To evaluate the feasibility of conducting standardized clinical assessments of pediatric and AYA B-ALL survivors post CD19-CAR T-cell therapy

    Estimation of participation rate

    Time frame: Through study completion, approximately 5 years

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Study locations

1 of 1 sites recruiting
  • St. Jude Children's Research Hospital
    Memphis, Tennessee 38105, United States
    Recruiting
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References and documents

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 29, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT07048535
Lead sponsor
St. Jude Children's Research Hospital
Responsible party
Sponsor
First posted
Jul 2, 2025
Start date
Oct 24, 2025
Primary completion
Jul 2028 (estimated)
Completion
Jul 2029 (estimated)
Last update
Apr 29, 2026

Study contacts

Aimee Talleur, MD
Contact
referralinfo@stjude.org
888-226-4343
Aimee Talleur, MD
principal investigator · St. Jude Children's Research Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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