Outcomes in Pediatric and Young Adult B-Cell Malignancies After Commercially Available Immunotherapy
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Stanford University
- Enrollment
- 500
- Locations
- 43
- Primary Endpoint
- Retrospective WECARE Survey
Study Overview
Brief 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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Other
Eligibility Criteria
- Ages
- — to 26 Years (Child, Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •* 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.
- •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.
Exclusion Criteria
- Not provided
Arms & Interventions
Arm A (Retrospective data)
Participants who have undergone standard of care tisagenlecleucel therapy, Participants will received a questionnaire study using patient reported outcomes.
Intervention: Questionnaire for patients receiving therapy (Other)
Arm B (Prospective data)
Patients enrolled in ARM B will be asked to participate in the biological sample collection. Participants will received a questionnaire
Intervention: Questionnaire for patients receiving therapy (Other)
Outcomes
Primary Outcomes
Retrospective WECARE Survey
Time Frame: up to 12 months post infusion
Surveys will be administered at a single time point post-CAR
WECARE-Survey
Time Frame: at baseline
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)
Secondary Outcomes
- duration of remission (DOR)(at baseline up to 12 months post infusion)
- overall survival (OS)(at baseline up to 12 months post infusion)
- event-free-survival (EFS)(at baseline up to 12 months post infusion)