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

Conditions

• Lymphoid Leukemia

Eligibility Criteria

Sex

ALL

Age

N/A - 26 Years

Healthy Volunteers

Not accepted

Interventions

• Questionnaire for patients receiving therapy — OTHER
  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.

Study Details

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.

Key Dates

Start date

Jun 29, 2023

Status verified

Jun 2026

Primary completion

Apr 30, 2027

Completion

Dec 31, 2038

Study Design

Enrollment

500 participants (estimated)

Arms

• Arm: Arm A (Retrospective data)
  Participants who have undergone standard of care tisagenlecleucel therapy, Participants will received a questionnaire study using patient reported outcomes.
• Arm: Arm B (Prospective data)
  Patients enrolled in ARM B will be asked to participate in the biological sample collection. Participants will received a questionnaire

Primary Outcome Measure

WECARE-Survey [ Time Frame: at baseline ]

Central Contacts

• Khanh Nguyen
  (650) 721-2372
  [email protected]

Locations (22)

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