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

June 2, 2026 updated by: Stanford University
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Arizona
      • Tucson, Arizona, United States, 85719
    • California
      • Duarte, California, United States, 91010
        • Recruiting
        • City of Hope Comprehensive Cancer Center
        • Contact:
      • Palo Alto, California, United States, 94305
        • Recruiting
        • Stanford University
        • Contact:
        • Principal Investigator:
          • Kara Davis, MD
      • San Francisco, California, United States, 94115
    • Delaware
      • New Castle, Delaware, United States, 19803
    • Florida
      • Gainesville, Florida, United States, 32610
        • Recruiting
        • University of Florida Health Science Center - Gainesville
        • Contact:
      • St. Petersburg, Florida, United States, 33701
        • Recruiting
        • Johns Hopkins All Children's Hospital
        • Contact:
    • Illinois
      • Chicago, Illinois, United States, 60611
    • Maryland
      • Baltimore, Maryland, United States, 21231
        • Recruiting
        • Johns Hopkins University/Sidney Kimmel Cancer Center
        • Contact:
    • Massachusetts
    • Michigan
      • Grand Rapids, Michigan, United States, 49503
    • Missouri
      • St Louis, Missouri, United States, 63110
        • Recruiting
        • St. Louis Children's (Washington University)
        • Contact:
    • New York
      • The Bronx, New York, United States, 10467
    • North Carolina
      • Charlotte, North Carolina, United States, 28262
    • Ohio
    • Oregon
      • Portland, Oregon, United States, 97239
        • Recruiting
        • OHSU Knight Cancer Institute
        • Principal Investigator:
          • Bill Chang, MD
        • Contact:
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15224
    • Texas
    • Virginia
      • Fairfax, Virginia, United States, 22203
    • Washington
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53226
        • Recruiting
        • Medical College of Wisconsin
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

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

Description

Inclusion Criteria (Arm A)

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

Who either:

  • Experienced refractory 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 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
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.
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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
WECARE-Survey
Time Frame: at 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)
at baseline
Retrospective WECARE Survey
Time Frame: up to 12 months post infusion
Surveys will be administered at a single time point post-CAR
up to 12 months post infusion

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
overall survival (OS)
Time Frame: at baseline up to 12 months post infusion
Overall survival was the duration from the start of study treatment to death.
at baseline up to 12 months post infusion
event-free-survival (EFS)
Time Frame: at baseline up to 12 months post infusion
probability of recurrence or progression of in patients
at baseline up to 12 months post infusion
duration of remission (DOR)
Time Frame: at baseline up to 12 months post infusion
at baseline up to 12 months post infusion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Stanford University

Collaborators

The Pediatric Oncology Experimental Therapeutics Investigators' Consortium

Investigators

  • Principal Investigator: Kara Davis, MD, Stanford University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 29, 2023

Primary Completion (Estimated)

April 1, 2027

Study Completion (Estimated)

December 31, 2038

Study Registration Dates

First Submitted

May 1, 2023

First Submitted That Met QC Criteria

May 9, 2023

First Posted (Actual)

May 18, 2023

Study Record Updates

Last Update Posted (Actual)

June 4, 2026

Last Update Submitted That Met QC Criteria

June 2, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB-70021
  • NCI-2024-06344 (Registry Identifier: National Cancer Institute: Clinical Trials Reporting Program)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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