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Recruiting

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

NCT05865301 · Stanford University
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About this study
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.
Eligibility criteria
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 design
Enrollment target: 500 participants
Age groups: child, adult
Timeline
Starts: 2023-06-29
Estimated completion: 2038-12-31
Last updated: 2026-06-04
Interventions
Other: Questionnaire for patients receiving therapy
Primary outcomes
  • WECARE-Survey (at baseline)
  • Retrospective WECARE Survey (up to 12 months post infusion)
Sponsor
Stanford University · other
With: The Pediatric Oncology Experimental Therapeutics Investigators' Consortium
Contacts & investigators
ContactKhanh Nguyen · contact · khanhpn@stanford.edu · (650) 721-2372
InvestigatorKara Davis, MD · principal_investigator, Stanford University
All locations (22)
Banner University Medical Center - TucsonRecruiting
Tucson, Arizona, United States
City of Hope Comprehensive Cancer CenterRecruiting
Duarte, California, United States
Stanford UniversityRecruiting
Palo Alto, California, United States
UCSF (Benioff Children's)Recruiting
San Francisco, California, United States
Nemours Children's HospitalRecruiting
New Castle, Delaware, United States
University of Florida Health Science Center - GainesvilleRecruiting
Gainesville, Florida, United States
Johns Hopkins All Children's HospitalRecruiting
St. Petersburg, Florida, United States
Ann & Robert H. Lurie Children's Hospital of ChicagoRecruiting
Chicago, Illinois, United States
Johns Hopkins University/Sidney Kimmel Cancer CenterRecruiting
Baltimore, Maryland, United States
Dana-Farber Cancer InstituteRecruiting
Boston, Massachusetts, United States
Corewell Health Grand Rapids Hospitals - Helen DeVos Children's HospitalRecruiting
Grand Rapids, Michigan, United States
St. Louis Children's (Washington University)Recruiting
St Louis, Missouri, United States
Children's Hospital at MontefioreRecruiting
The Bronx, New York, United States
Atrium Health Levine Cancer InstituteRecruiting
Charlotte, North Carolina, United States
Cincinnati Children's Hospital Medical CenterRecruiting
Cincinnati, Ohio, United States
OHSU Knight Cancer InstituteRecruiting
Portland, Oregon, United States
Children's Hospital of Pittsburgh of UPMCRecruiting
Pittsburgh, Pennsylvania, United States
UT Southwestern/Simmons Cancer Center-DallasRecruiting
Dallas, Texas, United States
Cook Children's Medical CenterRecruiting
Fort Worth, Texas, United States
Saint Jude Children's Research HospitalRecruiting
Fairfax, Virginia, United States
Seattle Children's HospitalRecruiting
Seattle, Washington, United States
Medical College of WisconsinRecruiting
Milwaukee, Wisconsin, United States