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NCT05969002

Pilot Prospective Study for PET-CT Imaging in Participants With Relapsed/Refractory Acute Leukemias

Sponsor: National Cancer Institute (NCI)

View on ClinicalTrials.gov

Summary

Background Acute lymphoblastic leukemia (ALL) accounts for about 25 percent of childhood cancers and for about 20 percent of adult leukemias. The disease can be treated with CAR T-cell infusion but non-central nervous system (CNS) extramedullary disease (EMD) is associated with lower rates of complete remission. 18-fludeoxyglucose (18F-FDG) positron emission tomography-computed tomography (PET-CT) has been shown to be effective for detection of non-CNS EMD in ALL. Pre and post CAR T-cell infusion may help to predict outcomes and risk of early progression. Objectives To describe the number of adults with relapsed/refractory B-cell ALL who proceed to CAR T-cell therapy. Eligibility Participants \>=18 years with relapsed/refractory B-cell ALL who are being screened for CAR T-cell clinical trial enrollment, and Participants \<18 with relapsed/refractory B cell ALL who are being screened for CAR T-cell clinical trial enrollment and have a clinical indication for FDG PET-CT prior to CAR infusion. Design Pilot study to add screening FDG PET-CT as part of the pre-CAR T-cell baseline evaluation with additional imaging at day 28 and future timepoints pending evidence of non-CNS EMD on initial scan.

Key Details

Gender

All

Age Range

5 Years - 39 Years

Study Type

OBSERVATIONAL

Enrollment

10

Start Date

2023-08-25

Completion Date

2025-12-01

Last Updated

2026-04-20

Healthy Volunteers

No

Locations (1)

National Institutes of Health Clinical Center

Bethesda, Maryland, United States