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

Обзор

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.

Вмешательства

• Другое Questionnaire 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.

Первичные конечные точки

• WECARE-Survey [Срок оценки: at baseline]
• Retrospective WECARE Survey [Срок оценки: up to 12 months post infusion]

Вторичные конечные точки (3)

• overall survival (OS) [Срок оценки: at baseline up to 12 months post infusion]
• event-free-survival (EFS) [Срок оценки: at baseline up to 12 months post infusion]
• duration of remission (DOR) [Срок оценки: at baseline up to 12 months post infusion]

Критерии участия

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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

США · 22 центра

• Banner University Medical Center - Tucson — Tucson
• City of Hope Comprehensive Cancer Center — Duarte
• Stanford University — Palo Alto
• UCSF (Benioff Children's) — San Francisco
• Nemours Children's Hospital — New Castle
• University of Florida Health Science Center - Gainesville — Gainesville
• Johns Hopkins All Children's Hospital — St. Petersburg
• Ann & Robert H. Lurie Children's Hospital of Chicago — Chicago
• … и ещё 14 центров

Идентификаторы

NCT: NCT05865301 · IRB-70021 · NCI-2024-06344

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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