RecruitingNCT05865301

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


Sponsor

Stanford University

Enrollment

500 participants

Start Date

Jun 29, 2023

Study Type

OBSERVATIONAL

Conditions

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.


Eligibility

Max Age: 26 Years

Plain Language Summary

Simplified for easier understanding

This observational study collects information about outcomes in children and young adults (up to age 26) with B-cell leukemia or lymphoma who are receiving or have received newer immunotherapy treatments — such as CAR T-cell therapy, blinatumomab, or inotuzumab — to better understand how well these treatments work in real-world settings. **You may be eligible if...** - You are 26 years old or younger - You have B-cell acute lymphoblastic leukemia (ALL) or B-cell lymphoma - You have relapsed or refractory disease, OR you are scheduled to receive or have previously received an approved immunotherapy (CAR T-cell therapy, blinatumomab, or inotuzumab) - You or your legal guardian can provide informed consent **You may NOT be eligible if...** - You are over 26 years of age - You have a different type of leukemia or lymphoma (not B-cell) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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.


Locations(21)

Banner University Medical Center - Tucson

Tucson, Arizona, United States

City of Hope Comprehensive Cancer Center

Duarte, California, United States

Stanford University

Palo Alto, California, United States

UCSF (Benioff Children's)

San Francisco, California, United States

Nemours Children's Hospital

New Castle, Delaware, United States

University of Florida Health Science Center - Gainesville

Gainesville, Florida, United States

Johns Hopkins All Children's Hospital

St. Petersburg, Florida, United States

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

Chicago, Illinois, United States

Johns Hopkins University/Sidney Kimmel Cancer Center

Baltimore, Maryland, United States

Dana-Farber Cancer Institute

Boston, Massachusetts, United States

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

Grand Rapids, Michigan, United States

St. Louis Children's (Washington University)

St Louis, Missouri, United States

Children's Hospital at Montefiore

The Bronx, New York, United States

Atrium Health Levine Cancer Institute

Charlotte, North Carolina, United States

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, United States

Children's Hospital of Pittsburgh of UPMC

Pittsburgh, Pennsylvania, United States

UT Southwestern/Simmons Cancer Center-Dallas

Dallas, Texas, United States

Cook Children's Medical Center

Fort Worth, Texas, United States

Saint Jude Children's Research Hospital

Fairfax, Virginia, United States

Seattle Children's Hospital

Seattle, Washington, United States

Medical College of Wisconsin

Milwaukee, Wisconsin, United States

View Full Details on ClinicalTrials.gov

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NCT05865301