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NCT05865301Recruiting

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

Stanford University

Start Date

6/29/2023

Completion Date

12/31/2038

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 Criteria

Age Range: No minimum to 26 years

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.

Interventions

OTHER

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Conditions

Lymphoid Leukemia

Locations

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

OHSU Knight Cancer Institute

Portland, Oregon 97239

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