Long-term health and quality of life after CD19 CAR T-cell therapy in B-ALL survivors

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

This project will test whether standardized health checks can be done for children, adolescents, and young adults who are at least two years past CD19 CAR T-cell treatment for B-ALL.

Quick facts

• Study type: Observational
• Enrollment: 80 (estimated)
• Sex: All
• Sponsor: St. Jude Children's Research Hospital (Academic / other)
• Drugs / interventions: CAR T, chimeric antigen receptor
• Locations: 1 site (Memphis, Tennessee)
• Trial ID: NCT07048535 on ClinicalTrials.gov

What this trial studies

St. Jude is running a prospective, observational program to recruit pediatric, adolescent, and young adult B-ALL survivors who are at least two years after receiving a CD19-containing CAR T-cell product. Participants will undergo comprehensive, standardized assessments including medical history and physical exam, laboratory studies, brain MRI, neurocognitive testing, physical performance testing, and immune function testing. The effort leverages the St. Jude Lifetime Cohort (SJLIFE) infrastructure to harmonize procedures and test feasibility of multi-institutional late-effects surveillance. The primary focus is on characterizing persistent and new late-onset health conditions, neurologic and neurocognitive outcomes, immune status, and functional performance after CAR T-cell therapy.

Who should consider this trial

Good fit: Ideal candidates are people who received a single CD19-containing CAR T-cell product for B-ALL at age 26 or younger, are in sustained remission (allowing for one hematopoietic cell transplant), and are at least two years after their most recent CAR infusion.

Not a fit: Patients unlikely to benefit include those who are less than two years post-CAR infusion, who received non-CD19 or multiple different CAR products, who are not in sustained remission, or who cannot provide consent or travel for in-person testing.

Why it matters

Potential benefit: If successful, the program could identify previously unrecognized late health problems and inform follow-up care to improve long-term quality of life for B-ALL survivors treated with CD19 CAR T-cells.

How similar studies have performed: While long-term survivorship cohorts exist for childhood cancers, studies specifically describing late effects after CD19 CAR T-cell therapy are limited and this multi-center CAR T-focused follow-up is largely novel.

Eligibility criteria

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:

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

Where this trial is running

Memphis, Tennessee

• St. Jude Children's Research Hospital — Memphis, Tennessee, United States (Recruiting)

Study contacts

• Principal investigator: Aimee Talleur, MD — St. Jude Children's Research Hospital
• Study coordinator: Aimee Talleur, MD

Conditions B-Cell Acute Lymphoblastic Leukemia; B-ALL; Survivorship