Protocol Details
Pilot Prospective Study for PET-CT Imaging in Participants with Relapsed/Refractory Acute Leukemias
This study is currently recruiting participants.
Summary
Number |
001620-C |
Sponsoring Institute |
National Cancer Institute (NCI) |
Recruitment Detail |
Type: Participants currently recruited/enrolled
Gender: Male & Female
Min Age: 5 Years
Max Age: 39 Years |
Referral Letter Required |
No |
Population Exclusion(s) |
Fetuses;
Neonates;
Pregnant Women |
Keywords |
Imaging;
Natural History;
ACUTE LEUKEMIA |
Recruitment Keyword(s) |
None |
Condition(s) |
B Cell;
Acute Lymphoblastic Leukemia;
Relapsed/Refractory |
Investigational Drug(s) |
None |
Investigational Device(s) |
None |
Intervention(s) |
None |
Supporting Site |
National Cancer Institute |
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.
Eligibility
INCLUSION CRITERIA:
-Diagnosis: Participants must have a B cell ALL (inclusive of CML with ALL transformation)
-Age: 5-39 years
--All participants >=18 years old with relapsed/refractory B cell ALL potentially proceeding to CAR therapy at the NIH, or
--Any participant <18 potentially proceeding to CAR therapy at the NIH with a clinical indication for FDG PET-CT prior to CAR infusion:
---History of prior EMD
---History of post-HSCT relapse
---Clinical signs or incidental findings suspicious for EMD
---Peripheral disease out of proportion of bone marrow disease burden
-Participants who are breastfeeding or plan to breastfeed must agree to discontinue/postpone breastfeeding within 24 hours of any PET-CT scan
-Ability and willingness of participant or Legally Authorized Representative (LAR) to co-enroll on protocol 10-C-0086 "Comprehensive Omics Analysis of Pediatric Solid Tumors and Establishment of a Repository for Related Biological Studies".
-Ability of participant or Legally Authorized Representative (LAR) to understand and the willingness to sign a written informed consent document.
EXCLUSION CRITERIA:
-Pregnant individuals are excluded from this study
-History of severe, immediate hypersensitivity reaction attributed to compounds of similar chemical or biologic composition to any agents used in study (e.g., FDG injection)
Citations:
Not Provided
Contacts:
Clinical Trials Number:
NCT05969002