Outcomes in Pediatric and Young Adult B-Cell Malignancies After Commercially Available Immunotherapy
Recruiting
- Conditions
- Lymphoid Leukemia
- Interventions
- Other: Questionnaire for patients receiving therapy
- Registration Number
- NCT05865301
- Lead Sponsor
- Stanford University
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 500
Inclusion Criteria
Not provided
Exclusion Criteria
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Arm B (Prospective data) Questionnaire for patients receiving therapy Patients enrolled in ARM B will be asked to participate in the biological sample collection. Participants will received a questionnaire Arm A (Retrospective data) Questionnaire for patients receiving therapy Participants who have undergone standard of care tisagenlecleucel therapy, Participants will received a questionnaire study using patient reported outcomes.
- Primary Outcome Measures
Name Time Method Retrospective WECARE Survey up to 12 months post infusion Surveys will be administered at a single time point post-CAR
WECARE-Survey 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 Outcome Measures
Name Time Method duration of remission (DOR) at baseline up to 12 months post infusion overall survival (OS) at baseline up to 12 months post infusion Overall survival was the duration from the start of study treatment to death.
event-free-survival (EFS) at baseline up to 12 months post infusion probability of recurrence or progression of in patients
Trial Locations
- Locations (1)
Stanford University
🇺🇸Palo Alto, California, United States