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

NCT05969002 | Completed

• 2 other identifiers: 10001620001620-C
• Study Type: observational
• Target: 10
• Locations: 1 country
• Sites: 1

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 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.

Conditions

B Cell; Acute Lymphoblastic Leukemia; Relapsed/Refractory

Keywords

Imaging; Natural History; ACUTE LEUKEMIA

Outcome Measures

Primary Outcomes (1)

• Proportion of non-CNS EMD in adult participants with relapsed/refractory B-ALL proceeding to CAR T-cell therapy

  Estimate the fraction of adult participants who are PET positive for non-CNS EMD

  3 months

Secondary Outcomes (2)

• Identify risk factors associated with presence of non-CNS EMD pre-CAR

  through 3 months post CAR T

• Determine proportion of non-CNS EMD with concurrent CNS disease or history of CNS disease

  At time of LP

Study Arms (2)

Adult

Participants \>/=18 years old with relapsed/refractory B cell ALL proceeding to CAR therapy at the NIH

Pediatric

Participants \<18 proceeding to CAR therapy at the NIH with a clinical indication for FDG PET-CT prior to CAR infusion

Eligibility Criteria

• Age: 5 Years - 39 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Primary care clinic

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (1)

National Institutes of Health Clinical Center

Bethesda, Maryland, 20892, United States

Location

Related Links

• NIH Clinical Center Detailed Web Page

MeSH Terms

Conditions

Precursor Cell Lymphoblastic Leukemia-Lymphoma; Recurrence

Condition Hierarchy (Ancestors)

Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Nirali N Shah, M.D.

  National Cancer Institute (NCI)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 31, 2023
• First Posted: August 1, 2023
• Study Start: August 25, 2023
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: April 29, 2026

Record last verified: 2026-04-16

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Clinical data will be made available during the study and indefinitely. Genomic data are available once genomic data are uploaded per protocol GDS plan for as long as database is active.
• Access Criteria: Clinical data will be made available upon request and with the permission of the study PI. Genomic data are made available via dbGAP through requests to the data custodians.

Locations

US (1)