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RecruitingObservational

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

NCT ID: NCT05865301Sponsor: Stanford UniversityLast updated: 2026-06-04

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.

Arms & 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.

Outcome measures

Primary

  • 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

  • Retrospective WECARE Survey

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

    Time frame: up to 12 months post infusion

Secondary

  • overall survival (OS)

    Time frame: at baseline up to 12 months post infusion

  • event-free-survival (EFS)

    Time frame: at baseline up to 12 months post infusion

  • duration of remission (DOR)

    Time frame: at baseline up to 12 months post infusion

Eligibility criteria

Sex: AllAge: Up to 26 YearsHealthy volunteers: No
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 locations (22)

Banner University Medical Center - Tucson

Tucson, Arizona, 85719

Recruiting
Laurel Truscott · Contact

City of Hope Comprehensive Cancer Center

Duarte, California, 91010

Recruiting
Lindsey Murphy · Contact

Stanford University

Palo Alto, California, 94305

Recruiting
Khanh Nguyen · Contact
Kara Davis, MD · Principal Investigator

UCSF (Benioff Children's)

San Francisco, California, 94115

Recruiting
William Temple · Contact

Nemours Children's Hospital

New Castle, Delaware, 19803

Recruiting
Ellen Fraint · Contact

University of Florida Health Science Center - Gainesville

Gainesville, Florida, 32610

Recruiting
John Ligon · Contact

Johns Hopkins All Children's Hospital

St. Petersburg, Florida, 33701

Recruiting
Natalie Booth · Contact

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

Chicago, Illinois, 60611

Recruiting
Kevin McNerney · Contact

Johns Hopkins University/Sidney Kimmel Cancer Center

Baltimore, Maryland, 21231

Recruiting
Stacy Cooper · Contact

Dana-Farber Cancer Institute

Boston, Massachusetts, 02215

Recruiting
Susanne Baumeister · Contact

Corewell Health Grand Rapids Hospitals - Helen DeVos Children's Hospital

Grand Rapids, Michigan, 49503

Recruiting
Troy Quigg · Contact

St. Louis Children's (Washington University)

St Louis, Missouri, 63110

Recruiting
Thomas Pfeiffer · Contact

Children's Hospital at Montefiore

The Bronx, New York, 10467

Recruiting
David Loeb · Contact

Atrium Health Levine Cancer Institute

Charlotte, North Carolina, 28262

Recruiting
Jeffrey Huo · Contact

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229

Recruiting
Christine Phillips · Contact
Christa Krupski · Contact

OHSU Knight Cancer Institute

Portland, Oregon, 97239

Recruiting
Bill Chang, MD · Contact
BIll Chang, MD · Principal Investigator

Children's Hospital of Pittsburgh of UPMC

Pittsburgh, Pennsylvania, 15224

Recruiting
Randy Windreich · Contact

UT Southwestern/Simmons Cancer Center-Dallas

Dallas, Texas, 75235

Recruiting
Samuel John · Contact

Cook Children's Medical Center

Fort Worth, Texas, 76104

Recruiting
Holly Pacenta · Contact

Saint Jude Children's Research Hospital

Fairfax, Virginia, 22203

Recruiting
Swati Naik · Contact

Seattle Children's Hospital

Seattle, Washington, 98105

Recruiting
Anurekha Hall · Contact

Medical College of Wisconsin

Milwaukee, Wisconsin, 53226

Recruiting
Amy Moskop · Contact