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

Recruiting

• Conditions: Lymphoid Leukemia

• 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

Study Timeline

• Study First Submitted: 2023-05-01
• Study First Submitted QC: 2023-05-09
• Study First Posted: 2023-05-18
• Study Start: 2023-06-29
• Status Verified: 2025-08
• Last Update Submitted: 2025-08-20
• Last Update Posted: 2025-08-27
• Primary Completion: 2025-12-30
• Study Completion: 2038-12-31

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

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
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
duration of remission (DOR)	at baseline up to 12 months post infusion

Trial Locations

Locations (21)

Banner University Medical Center - Tucson; 🇺🇸 Tucson, Arizona, United States

City of Hope Comprehensive Cancer Center; 🇺🇸 Duarte, California, United States

Stanford University; 🇺🇸 Palo Alto, California, United States

UCSF (Benioff Children's); 🇺🇸 San Francisco, California, United States

Nemours Children's Hospital; 🇺🇸 New Castle, Delaware, United States

University of Florida Health Science Center - Gainesville; 🇺🇸 Gainesville, Florida, United States

Johns Hopkins All Children's Hospital; 🇺🇸 St. Petersburg, Florida, United States

Ann & Robert H. Lurie Children's Hospital of Chicago; 🇺🇸 Chicago, Illinois, United States

Johns Hopkins University/Sidney Kimmel Cancer Center; 🇺🇸 Baltimore, Maryland, United States

Dana-Farber Cancer Institute; 🇺🇸 Boston, Massachusetts, United States

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