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

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05865301
Enrollment
500
Registered
2023-05-18
Start date
2023-06-29
Completion date
2038-12-31
Last updated
2026-06-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lymphoid Leukemia

Keywords

PRWCC, Foresight

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.

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.

Sponsors

Stanford University
Lead SponsorOTHER
The Pediatric Oncology Experimental Therapeutics Investigators' Consortium
CollaboratorOTHER

Study design

Observational model
COHORT
Time perspective
OTHER

Eligibility

Sex/Gender
ALL
Age
No minimum to 26 Years
Healthy 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.

Design outcomes

Primary

MeasureTime frameDescription
WECARE-Surveyat baselineParticipant 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 infusionSurveys will be administered at a single time point post-CAR

Secondary

MeasureTime frameDescription
overall survival (OS)at baseline up to 12 months post infusionOverall survival was the duration from the start of study treatment to death.
event-free-survival (EFS)at baseline up to 12 months post infusionprobability of recurrence or progression of in patients
duration of remission (DOR)at baseline up to 12 months post infusion

Countries

United States

Contacts

CONTACTKhanh Nguyen
khanhpn@stanford.edu(650) 721-2372
PRINCIPAL_INVESTIGATORKara Davis, MD

Stanford University

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 5, 2026