RightFit
RecruitingPhase not listed

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
No age limits stated
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: Infusions, MRI scans, Physical exams

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "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."
  • "These assessments will include history and physical examination, laboratory studies, a brain MRI, physical performance testing, and neurocognitive testing."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study looks at long-term health in people treated for B-cell acute lymphoblastic leukemia (B-ALL), a blood cancer. It is for survivors who received CAR T-cell therapy, which uses changed immune cells to target cancer, at least 2 years ago. Researchers will study whether health checks across several hospitals are practical and look at thinking, nerves, immune health, and daily function.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Were age 26 or younger when you first received CAR T-cell treatment.
  • Received CAR T-cells that target CD19 for B-ALL, either as research or approved treatment.
  • Received only one type of CAR T-cell product. Repeat doses of that same product are allowed.
  • Have stayed in remission, with no signs of cancer, without more treatment after CAR T-cells. A stem cell transplant to strengthen the treatment result is allowed.
  • Received only one stem cell transplant, either before or after CAR T-cell treatment.
  • It has been at least 2 years since your last CAR T-cell dose.

Who can't join

  • You or your legal guardian or representative cannot or will not give written consent to join the study.

Simplified for readability. The official criteria below are what the study team uses.

Official 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

Study sites (1)

TN