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Cognitive Aftereffects of Neurotoxicity in Children and Young Adults With Relapsed/Refractory Hematologic Malignancies Who Receive CAR T-cell Therapy

Investigation of the Cognitive Aftereffects of Neurotoxicity in Children and Young Adults With Relapsed/Refractory Hematologic Malignancies Who Receive CAR T-cell Therapy

Who can join

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

Age
5 Years and older
Sex
All sexes
Healthy volunteers
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

  • Time periods mentioned: 3 years
  • Procedures mentioned: Infusions

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
  • "Participation will last for up to 3 years."
  • "Participants with the disease and their informants will be enrolled in this study during the preparation of participants for CAR T-cell therapy and followed for up to 3 years post CAR infusion."
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 whether CAR T-cell therapy affects thinking, learning, and memory. This treatment changes a person’s immune cells to fight cancer. The study is for people ages 5–35 whose blood cancer came back or did not respond to treatment, and their caregivers.

Background: CAR T-cell therapy is a promising new treatment for blood cancers. During treatment, a person s T-cells are genetically changed to kill cancer cells. Researchers want to learn more about the effects of potential problems that may be associated with this treatment. We are specifically interested in learning if and how this treatment may affect the brain or your thinking skills. Objective: To learn if CAR T-cell therapy can affect how children and adults think, process, and remember things. Eligibility: People aged 5-35 who have blood cancer that has not responded to treatment, or the blood cancer has come back after treatment, and who will receive CAR T-cell therapy. Caregivers are also needed. All participants must be able to speak and read in English or Spanish. Design: Participants will be screened with a medical history. Information from participants medical records will be collected. Participants will take tests at home or at NIH to see how well they think, read, learn, remember, reason, and pay attention. The tests will be both computerized and paper/pencil. They will take less than 1 hour to complete. Participants and a parent/adult observer will complete a 5-minute Background Information Form and a checklist of nervous system symptoms. If participants are 5 years or older, they will participate in activities to test their ability to do different thinking tasks, like answer questions, complete puzzle patterns, and remember things. Participants and their caregivers will complete questions to see if they are having specific symptoms related to receiving CAR T-cells. The questions will assess their well-being and needs. The questions will take less than 1 hour to complete. Some tests and questions will be repeated at different time points in the study. Participation will last for up to 3 years.

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

Eligibility

Who can join

  • Patients must be ages 5–35 with leukemia or lymphoma, types of blood cancer, that came back or did not respond to treatment.
  • Patients must be scheduled for CAR T-cell treatment at a study site. If they are in a CAR T-cell treatment study, that study must allow data sharing.
  • Patients must have a caregiver willing to answer questions about them.
  • Patients must speak and understand English or Spanish. Caregivers must speak and read English or Spanish.
  • Patients must have a computer or tablet with a camera and internet access. Caregivers must have a computer or tablet.
  • Caregivers must be at least 18 and care for a patient in this study.
  • Caregivers must help set up a suitable place for testing at home for patients under 18, and for adults who need help.
  • Patients or their parent or guardian must understand and sign a consent form. Caregivers must also understand and sign a consent form.

Who can't join

  • Patients cannot join if they already have a global intellectual disability, meaning broad limits in learning and thinking, such as Down syndrome.

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

Official eligibility criteria

* INCLUSION CRITERIA: * Participants with disease * Participants are diagnosed with relapsed/refractory leukemias or lymphomas, and are scheduled to receive CAR T-cell treatment in one of the enrolling sites * For participants enrolled on a CAR T-cell treatment protocol, data sharing for the purposes of this study must be allowed. * Age \>= 5 and \<=35 years old * Participant must have an eligible caregiver (informant) who is willing to complete assessments about the participant of this study * Participants (\<18 years, or \>=18 years if needed) must have an eligible caregiver to assist with setting up an appropriate test environment for the remote evaluations * Participant must be able to speak and understand English or Spanish * Participants must have access to a computer or tablet with a camera and an internet connection * Participant or parent/guardian must be able to understand and willing to sign a written consent document * Caregivers (informants) * Participants must be able to speak and read in English or Spanish * Participants who are caregivers for participants with disease addressed above * Age \>= 18 years old * Participants must have access to a computer or tablet * Participants (of children \<18 years, or \>18 years if needed) must be willing to help set up an appropriate test environment for the remote evaluations * Participant is able to understand and willing to sign a written consent document EXCLUSION CRITERIA: -Participants with disease who have a pre-existing global intellectual disability (e.g., Down Syndrome)

Study sites (3)

CA

MD

  • National Institutes of Health Clinical Center · Bethesda, MD 20892For more information at the NIH Clinical Center contact National Cancer Institute Referral Office · Study contact · 888-624-1937More trials in Bethesda

WA