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Observational Study of Immunotherapy for Pediatric and Young Adult B-Cell Malignancies

This observational study is looking at how children and young adults (up to age 26) with B-cell malignancies (cancers of certain white blood cells) respond to immunotherapy treatments like Kymriah™ (tisagenlecleucel), blinatumomab, and inotuzumab ozogamicin. The study aims to understand the real-world outcomes for patients receiving these commercially available therapies. You might be able to join if you have B-cell precursor acute lymphoblastic leukemia (ALL) or B-cell lymphoma that has come back or didn't respond to standard chemotherapy, or if you've already received one of these immunotherapy treatments. Researchers will use questionnaires to gather information about your health and social factors. The main goal is to see how patients are doing at the start of treatment and up to 12 months afterward. The current recruitment status is unclear.

Study design
This is an observational study, meaning researchers will collect information without giving new treatments. It plans to include up to 500 participants.
What's involved
You would complete questionnaires at the start of treatment, and then at 1, 3, 6, and 12 months after receiving your CAR T-cell infusion.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for up to 12 months after their immunotherapy infusion.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05865301

Outcomes in Pediatric and Young Adult B-Cell Malignancies After Commercially Available Immunotherapy

Recruiting
Not specifiedUp to 26Observational
Stanford University
~500 participants
Updated 2026-06-04 on ClinicalTrials.gov
What's tested:Questionnaire for patients receiving therapy

At a glance

Recruiting sites
22 of 22 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
WECARE-Survey
Measured over at baseline
+1 more outcome measured

Conditions

Lymphoid Leukemia

Explore related trials

B-Cell Non-Hodgkin LymphomaPrecursor B-cell acute lymphoblastic leukemia

NCT05865301

Where you'd take part

This study runs at 22 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Ann & Robert H. Lurie Children's Hospital of Chicago

    Chicago, Illinoisstudy coordinator listed

    Recruiting

  • Atrium Health Levine Cancer Institute

    Charlotte, North Carolinastudy coordinator listed

    Recruiting

  • Banner University Medical Center - Tucson

    Tucson, Arizonastudy coordinator listed

    Recruiting

  • Children's Hospital at Montefiore

    The Bronx, New Yorkstudy coordinator listed

    Recruiting

  • Children's Hospital of Pittsburgh of UPMC

    Pittsburgh, Pennsylvaniastudy coordinator listed

    Recruiting

  • Cincinnati Children's Hospital Medical Center

    Cincinnati, Ohiostudy coordinator listed

    Recruiting

  • City of Hope Comprehensive Cancer Center

    Duarte, Californiastudy coordinator listed

    Recruiting

  • Cook Children's Medical Center

    Fort Worth, Texasstudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Kara Davis, MD · PRINCIPAL_INVESTIGATOR · Stanford University

Who to contact

Khanh Nguyen
[email protected]
(650) 721-2372
Email the study team

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Eligibility criteria

Inclusion

Experienced refractory or relapsed disease, treated with standard chemotherapy, without immunotherapy treatment.
Previously undergone standard of care immunotherapy with FDA approved therapies, such as Kymriah™ (CTL019, tisagenlecleucel), blinatumomab or
Age: Greater than or equal to 0 year of age and less than or equal to 26 years of age.
Disease Status - B cell precursor acute lymphoblastic leukemia (ALL) or B cell lymphoma
Age: Greater than or equal to 0 year of age and less than or equal to 26 years of age
Patients who are either:
Undergoing evaluation for leukapheresis for planned standard of care tisagenlecleucel therapy, or planned for therapy with blinatumomab or inotuzumab. (Patients who received prior tisagenlecleucel, blinatumomab or inotuzumab on an established clinical trial and are now scheduled for commercial CAR, blinatumomab or inotuzumab therapy are also eligible) Or
Experienced refractory or relapsed B cell precursor acute lymphoblastic leukemia (ALL) or B cell lymphoma
Ability to give informed consent. All subjects ≥ 18 years of age must be able to give informed consent or have legal authorized representative (LAR) (i.e. parent or guardian) to consent, if not in capacity to give consent independently. For subjects \<18 years old their LAR must give informed consent. Pediatric subjects will be included in age appropriate discussion and written assent will be obtained for those \> 7 years of age, when appropriate, according to institutional procedures.

What this trial measures

  • WECARE-Surveyat baseline

    Participant will take part in a one-time questionnaire to address CAR specific questions. WECARE survey, consists of questions used to identify seven unmet material needs (education, employment, food security, housing, childcare, household heat, language)

  • Retrospective WECARE Surveyup to 12 months post infusion

    Surveys will be administered at a single time point post-CAR