ClinicalTrials.gg
RecruitingNCT05865301Updated Jun 4, 2026

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

An observational study in Lymphoid Leukemia, sponsored by Stanford University. Recruiting at 22 sites in United States. Open to participants aged Up to 26 Years. Per ClinicalTrials.gov, last updated 2026-06-04.

Sponsored by Stanford University · Observational

From the registry’s dates

  • Started Jun 2023; still recruiting 3 years 4 months later.
Study type
Observational
Model
Cohort
Time perspective
Other
Enrollment
500
Ages
Up to 26 Years
Sex
All
01

Study summary

To use a consistent and standardized platform to retrospectively and prospectively study children and young adults with B cell malignancies receiving Immunotherapy, blinatumomab and/or inotuzumab ozogamicin.

02

Conditions studied

  • Lymphoid Leukemia

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Keywords

  • PRWCC
  • Foresight
03

In context

Leukemia, Lymphoid

92 studies on the registry are indexed under Leukemia, Lymphoid; 14 are open to participants now.

Browse Leukemia, Lymphoid studies →

Lead sponsor

Stanford University is the lead sponsor of 2,168 studies on the registry; 431 are open to participants now.

Of its 267 completed or terminated interventional studies of FDA-regulated products, 207 (78%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Up to 26 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Both Arm A and Arm B, includes retrospective and prospective data collection for patients experiencing refractory disease or first relapse, who have not received immunotherapy and are not yet being considered for immunotherapy. Retrospective data collection will parallel Arm A and patients will not require consent or assent. Prospective data collection will parallel Arm B and will require patient consent and assent as relevant

Eligibility criteria

Inclusion Criteria (Arm A)

* Disease Status - B cell precursor acute lymphoblastic leukemia (ALL) or B cell lymphoma

Who either:

  • Experienced or relapsed disease, treated with standard chemotherapy, without immunotherapy treatment.

OR

  • 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.

Inclusion Criteria (Arm B)

  • 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 . 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.
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Relapsed and refractory

Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Observational model
Cohort
Time perspective
Other
Enrollment
500 participants (estimated)
Patient registry
No

Groups and cohorts

  • Arm A (Retrospective data)

    Participants who have undergone standard of care tisagenlecleucel therapy, Participants will received a questionnaire study using patient reported outcomes.

    Other: Questionnaire for patients receiving therapy

  • Arm B (Prospective data)

    Patients enrolled in ARM B will be asked to participate in the biological sample collection. Participants will received a questionnaire

    Other: Questionnaire for patients receiving therapy

Interventions

  • OtherQuestionnaire for patients receiving therapy

    Questionnaires will be given (at baseline, 1, 3, 6, and 12 months post CAR infusion) including baseline demographics, individual/family and neighborhood socioeconomic data, measures of household material hardship (housing and transportation insecurity, household energy and food insecurity), barriers to care at the CAR T cell institution, as well as patient reported outcomes following Kymriah infusion.

06

What researchers measure

Primary outcomes

  1. WECARE-Survey

    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)

    Time frame: at baseline

  2. Retrospective WECARE Survey

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

    Time frame: up to 12 months post infusion

Secondary outcomes

  1. overall survival (OS)

    Overall survival was the duration from the start of study treatment to death.

    Time frame: at baseline up to 12 months post infusion

  2. event-free-survival (EFS)

    probability of recurrence or progression of in patients

    Time frame: at baseline up to 12 months post infusion

  3. duration of remission (DOR)

    Time frame: at baseline up to 12 months post infusion

07

Study locations

22 of 22 sites recruiting
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Jun 2023 (actual). Primary completion is estimated for Apr 2027, 46 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
May 1, 2023
First posted
May 18, 2023
StartActual
Jun 29, 2023
Primary completionEst.
Apr 2027
CompletionEst.
Dec 31, 2038
Last update
Jun 4, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jun 4, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05865301
Collaborators
The Pediatric Oncology Experimental Therapeutics Investigators' Consortium
Responsible party
Sponsor
First posted
May 18, 2023
Start date
Jun 29, 2023
Primary completion
Apr 2027 (estimated)
Completion
Dec 31, 2038 (estimated)
Last update
Jun 4, 2026

Study contacts

Khanh Nguyen
Contact
khanhpn@stanford.edu
(650) 721-2372
Kara Davis, MD
principal investigator · Stanford University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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