Outcomes in Pediatric and Young Adult B-Cell Malignancies After Commercially Available Immunotherapy
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
Study locations (22)
Banner University Medical Center - Tucson
Tucson, Arizona, 85719
City of Hope Comprehensive Cancer Center
Duarte, California, 91010
Stanford University
Palo Alto, California, 94305
UCSF (Benioff Children's)
San Francisco, California, 94115
Nemours Children's Hospital
New Castle, Delaware, 19803
University of Florida Health Science Center - Gainesville
Gainesville, Florida, 32610
Johns Hopkins All Children's Hospital
St. Petersburg, Florida, 33701
Ann & Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinois, 60611
Johns Hopkins University/Sidney Kimmel Cancer Center
Baltimore, Maryland, 21231
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215
Corewell Health Grand Rapids Hospitals - Helen DeVos Children's Hospital
Grand Rapids, Michigan, 49503
St. Louis Children's (Washington University)
St Louis, Missouri, 63110
Children's Hospital at Montefiore
The Bronx, New York, 10467
Atrium Health Levine Cancer Institute
Charlotte, North Carolina, 28262
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229
OHSU Knight Cancer Institute
Portland, Oregon, 97239
Children's Hospital of Pittsburgh of UPMC
Pittsburgh, Pennsylvania, 15224
UT Southwestern/Simmons Cancer Center-Dallas
Dallas, Texas, 75235
Cook Children's Medical Center
Fort Worth, Texas, 76104
Saint Jude Children's Research Hospital
Fairfax, Virginia, 22203
Seattle Children's Hospital
Seattle, Washington, 98105
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226