This study is currently recruiting participants.
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)
Investigational Device(s)
Intervention(s)
Supporting Site
National Cancer Institute
Acute lymphoblastic leukemia (ALL) accounts for about 25% of childhood cancers and for about 20% 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.
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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 coenroll 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 women 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)
-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 coenroll 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 women 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)
Principal Investigator
Referral Contact
For more information: