Outcomes in Pediatric and Young Adult B-Cell Malignancies After Commercially Available Immunotherapy
This study collects information about treatment with commercially available immunotherapy for childhood B cell cancers.
Inclusion Criteria
- * ARM A OR CONTROL ARM: ** 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 inotuzumab ** Greater than or equal to 0 year of age and less than or equal to 26 years of age at the time of immunotherapy treatment * ARM B: ** B cell precursor acute lymphoblastic leukemia (ALL) or B cell lymphoma ** Greater than or equal to 0 year of age and less than or equal to 26 years of age at the time of immunotherapy treatment ** 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 sponsor and potential other locations can be found on ClinicalTrials.gov for NCT05865301.
Locations matching your search criteria
United States
Arizona
Tucson
California
Duarte
Palo Alto
San Francisco
Florida
Gainesville
Orlando
Saint Petersburg
Illinois
Chicago
Maryland
Baltimore
Michigan
Grand Rapids
Missouri
Saint Louis
New York
Bronx
North Carolina
Charlotte
Ohio
Cincinnati
Pennsylvania
Pittsburgh
Tennessee
Memphis
Texas
Dallas
Fort Worth
Washington
Seattle
Wisconsin
Milwaukee
PRIMARY OBJECTIVE:
I. Establish response, toxicity and survival outcomes in children and young adults with B-cell malignancies (i.e. B-cell ALL or B-cell Lymphoma) undergoing FDA approved immunotherapies (i.e. tisagenlecleucel [Kymriah (trademark)], blinatumomab [BLINCYTO (registered trademark)] and/or inotuzumab ozogamicin [BESPONSA (trademark)]) through retrospective and prospective data collection.
OUTLINE: This is an observational study. Patients are assigned to 1 of 3 arms.
ARM A: Patients may optionally complete a questionnaire as well as contribute previously banked samples for analysis on study. Patients also have their medical records reviewed on study.
ARM B: Patients may optionally complete questionnaires as well as undergo optional blood, bone marrow, stool, or CSF sample collection throughout the study. Patients also have their medical records reviewed on study.
CONTROL ARM: Patients have their medical records reviewed on study.
Trial PhaseNo phase specified
Trial TypeNot provided by clinicaltrials.gov
Lead OrganizationStanford Cancer Institute Palo Alto
Principal InvestigatorLiora Michal Schultz
- Primary IDPEDSHEM0016
- Secondary IDsNCI-2024-06344
- ClinicalTrials.gov IDNCT05865301