Status:
RECRUITING
Pilot Prospective Study for PET-CT Imaging in Participants With Relapsed/Refractory Acute Leukemias
Lead Sponsor:
National Cancer Institute (NCI)
Conditions:
B Cell
Acute Lymphoblastic Leukemia
Eligibility:
All Genders
5-39 years
Brief 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 n...
Detailed Description
Background * Acute lymphoblastic leukemia (ALL) is the most common pediatric malignancy, accounting for approximately 25 percent of all childhood cancer. ALL also spans the age spectrum and represent...
Eligibility Criteria
Inclusion
- 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)
Exclusion
Key Trial Info
Start Date :
August 25 2023
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
April 30 2026
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT05969002
Start Date
August 25 2023
End Date
April 30 2026
Last Update
December 31 2025
Active Locations (1)
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1
National Institutes of Health Clinical Center
Bethesda, Maryland, United States, 20892