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

Study Overview
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Brief Summary
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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.

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

Conditions
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Lymphoid Leukemia

Intervention / Treatment
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* Other: Questionnaire for patients receiving therapy


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Maximum Age: 26 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Arm A (Retrospective data)<br>Participants who have undergone standard of care tisagenlecleucel therapy, Participants will received a questionnaire study using patient reported outcomes. | Other: Questionnaire for patients receiving therapy<br>* 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.<br>|
| Arm B (Prospective data)<br>Patients enrolled in ARM B will be asked to participate in the biological sample collection. Participants will received a questionnaire | Other: Questionnaire for patients receiving therapy<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| WECARE-Survey | Participant will take part in a one-time questionnaire to address CAR specific questions. WECARE survey, consists of questions used to identify seven unmet material needs (education, employment, food security, housing, childcare, household heat, language) | at baseline | 
| Retrospective WECARE Survey | Surveys will be administered at a single time point post-CAR | up to 12 months post infusion | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| overall survival (OS) | Overall survival was the duration from the start of study treatment to death. | at baseline up to 12 months post infusion | 
| event-free-survival (EFS) | probability of recurrence or progression of in patients | at baseline up to 12 months post infusion | 
| duration of remission (DOR) |  | at baseline up to 12 months post infusion |