Outcomes in Pediatric and Young Adult B-Cell Malignancies After Commercially Available Immunotherapy
3 other identifiers
observational
500
1 country
21
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jun 2023
Longer than P75 for all trials
21 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 1, 2023
CompletedFirst Posted
Study publicly available on registry
May 18, 2023
CompletedStudy Start
First participant enrolled
June 29, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 30, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2038
ExpectedFebruary 9, 2026
February 1, 2026
2.8 years
May 1, 2023
February 5, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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)
at baseline
Retrospective WECARE Survey
Surveys will be administered at a single time point post-CAR
up to 12 months post infusion
Secondary Outcomes (3)
overall survival (OS)
at baseline up to 12 months post infusion
event-free-survival (EFS)
at baseline up to 12 months post infusion
duration of remission (DOR)
at baseline up to 12 months post infusion
Study Arms (2)
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
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.
Eligibility Criteria
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
You may qualify if:
- \* 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.
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (21)
Banner University Medical Center - Tucson
Tucson, Arizona, 85719, United States
City of Hope Comprehensive Cancer Center
Duarte, California, 91010, United States
Stanford University
Palo Alto, California, 94305, United States
UCSF (Benioff Children's)
San Francisco, California, 94115, United States
Nemours Children's Hospital
New Castle, Delaware, 19803, United States
University of Florida Health Science Center - Gainesville
Gainesville, Florida, 32610, United States
Johns Hopkins All Children's Hospital
St. Petersburg, Florida, 33701, United States
Ann & Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinois, 60611, United States
Johns Hopkins University/Sidney Kimmel Cancer Center
Baltimore, Maryland, 21231, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215, United States
Corewell Health Grand Rapids Hospitals - Helen DeVos Children's Hospital
Grand Rapids, Michigan, 49503, United States
St. Louis Children's (Washington University)
St Louis, Missouri, 63110, United States
Children's Hospital at Montefiore
The Bronx, New York, 10467, United States
Atrium Health Levine Cancer Institute
Charlotte, North Carolina, 28262, United States
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229, United States
Children's Hospital of Pittsburgh of UPMC
Pittsburgh, Pennsylvania, 15224, United States
UT Southwestern/Simmons Cancer Center-Dallas
Dallas, Texas, 75235, United States
Cook Children's Medical Center
Fort Worth, Texas, 76104, United States
Saint Jude Children's Research Hospital
Fairfax, Virginia, 22203, United States
Seattle Children's Hospital
Seattle, Washington, 98105, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Liora Schultz, M.D
Stanford University
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- OTHER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 1, 2023
First Posted
May 18, 2023
Study Start
June 29, 2023
Primary Completion
April 30, 2026
Study Completion (Estimated)
December 31, 2038
Last Updated
February 9, 2026
Record last verified: 2026-02