Recruiting

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

Sponsor:

Stanford University

Code:

NCT05865301

Conditions

Lymphoid Leukemia

Eligibility Criteria

Sex: All

Age: 0 - 26

Healthy Volunteers: Not accepted

Interventions

Questionnaire for patients receiving therapy

Study Details

Brief 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.

Conditions

Lymphoid Leukemia

Study ID

NCT05865301

Start date

Jun 29, 2023

Status verified date

Jun, 2026

Completion date

Dec 31, 2038

Anticipated

Primary completion date

Apr, 2027

Anticipated

Eligibility Criteria

Sex: All

Age: 0 - 26

Healthy Volunteers: Not accepted

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.

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 Design

Enrollment

500 participants

Anticipated

Interventions and Outcome Measures

Arms

Arm A (Retrospective data)

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

Arm B (Prospective data)

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

Interventions

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.

Primary outcome measure

WECARE-Survey [ Time Frame: at baseline ]
Retrospective WECARE Survey [ Time Frame: up to 12 months post infusion ]

Central Contacts and Locations

Central contacts

Khanh Nguyen

(650) 721-2372 khanhpn@stanford.edu

Locations

Banner University Medical Center - Tucson

Recruiting

Tucson, Arizona, United States, 85719

Contacts

Laurel Truscott

ltruscott@peds.arizona.edu

City of Hope Comprehensive Cancer Center

Recruiting

Duarte, California, United States, 91010

Contacts

Lindsey Murphy

lmurphy@coh.org

Stanford University

Recruiting

Palo Alto, California, United States, 94305

Contacts

Khanh Nguyen

650-721-2372 khanhpn@stanford.edu

Principal Investigator:

Kara Davis, MD

UCSF (Benioff Children's)

Recruiting

San Francisco, California, United States, 94115

Contacts

William Temple

william.temple@ucsf.edu

Nemours Children's Hospital

Recruiting

New Castle, Delaware, United States, 19803

Contacts

Ellen Fraint

Ellen.Fraint@nemours.org

University of Florida Health Science Center - Gainesville

Recruiting

Gainesville, Florida, United States, 32610

Contacts

John Ligon

john.ligon@ufl.edu

Johns Hopkins All Children's Hospital

Recruiting

St. Petersburg, Florida, United States, 33701

Contacts

Natalie Booth

nbooth3@jh.edu

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

Recruiting

Chicago, Illinois, United States, 60611

Contacts

Kevin McNerney

kmcnerney@luriechildrens.org

Johns Hopkins University/Sidney Kimmel Cancer Center

Recruiting

Baltimore, Maryland, United States, 21231

Contacts

Stacy Cooper

scoope30@jhmi.edu

Dana-Farber Cancer Institute

Recruiting

Boston, Massachusetts, United States, 02215

Contacts

Susanne Baumeister

susanne_baumeister@dfci.harvard.edu

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

Recruiting

Grand Rapids, Michigan, United States, 49503

Contacts

Troy Quigg

troy.quigg@corewellhealth.org;

St. Louis Children's (Washington University)

Recruiting

St Louis, Missouri, United States, 63110

Contacts

Thomas Pfeiffer

pthomas@wustl.edu

Children's Hospital at Montefiore

Recruiting

The Bronx, New York, United States, 10467

Contacts

David Loeb

david.loeb@einsteinmed.edu

Atrium Health Levine Cancer Institute

Recruiting

Charlotte, North Carolina, United States, 28262

Contacts

Jeffrey Huo

Jeffrey.Huo@atriumhealth.org

Cincinnati Children's Hospital Medical Center

Recruiting

Cincinnati, Ohio, United States, 45229

Contacts

Christine Phillips

christine.phillips@cchmc.org

Christa Krupski

christa.krupski@cchmc.org

OHSU Knight Cancer Institute

Recruiting

Portland, Oregon, United States, 97239

Contacts

Bill Chang, MD

changb@ohsu.edu

Principal Investigator:

BIll Chang, MD

Children's Hospital of Pittsburgh of UPMC

Recruiting

Pittsburgh, Pennsylvania, United States, 15224

Contacts

Randy Windreich

Randy.Windreich@chp.edu

UT Southwestern/Simmons Cancer Center-Dallas

Recruiting

Dallas, Texas, United States, 75235

Contacts

Samuel John

samuel.john@utsouthwestern.edu

Cook Children's Medical Center

Recruiting

Fort Worth, Texas, United States, 76104

Contacts

Holly Pacenta

holly.pacenta@cookchildrens.org

Saint Jude Children's Research Hospital

Recruiting

Fairfax, Virginia, United States, 22203

Contacts

Swati Naik

swati.naik@stjude.org

Seattle Children's Hospital

Recruiting

Seattle, Washington, United States, 98105

Contacts

Anurekha Hall

Anurekha.Hall@seattlechildrens.org

Medical College of Wisconsin

Recruiting

Milwaukee, Wisconsin, United States, 53226

Contacts

Amy Moskop

amoskop@mcw.edu

More Information

Sponsor

Stanford University

Last update posted

Jun 4, 2026

Last verified

Jun, 2026

Keywords

PRWCC
Foresight

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Stanford University on 2026-06-04.