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

Inclusion Criteria12

  • \* 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.
  • 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.

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