Evaluating the delayed effects of CAR T cell therapy in children

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to assess the short-term and long-term side effects of CAR T cell therapy in pediatric patients. Researchers will monitor the incidence and severity of bone marrow dysfunction, infections, and neurotoxicity at various intervals following treatment. Data will be collected at 3 months, 6 months, 1 year, and 2 years post-infusion, allowing for a comprehensive understanding of the therapy's delayed effects. The study focuses on patients with B-ALL, hematologic malignancies, and solid tumors.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Participants must have received an initial systemically-administered CAR T cell infusion for an oncologic diagnosis within the last 1-3 months (+/- 14 days).

  * Initial infusion is defined as the first administration of a CAR T cell product the participant has not previously received OR receipt of a CAR T cell product previously received after an interval allogeneic HSCT.
* Age ≤ 30 years at CAR T cell infusion.

Exclusion Criteria:

* Active malignancy other than the disease under study.
* Planned consolidative HSCT within 3 months post CAR T cell infusion.
* Received or planned additional disease directed therapy post CAR T cell infusion.
* Inability or unwillingness of research participant or legal guardian/representative to give written informed consent.

Where it's running

• Children's Hospital Los Angeles
  Los Angeles, California, United States Recruiting
• Childrens Hospital of Colorado
  Aurora, Colorado, United States Recruiting
• Children's Hospital of Philadelphia
  Philadelphia, Pennsylvania, United States Recruiting
• St. Jude Children's Research Hospital
  Memphis, Tennessee, United States Recruiting
• Primary Children's Hospital
  Salt Lake City, Utah, United States Recruiting
• Seattle Childrens Hospital
  Seattle, Washington, United States Recruiting

Study contacts

• Principal investigator: Rebecca Epperly, MD — St. Jude Children's Research Hospital
• Study coordinator: Rebecca Epperly, MD
• Email: referralinfo@stjude.org
• Phone: 888-226-4343

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.