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

Launched by NATIONAL CANCER INSTITUTE (NCI) · Jul 31, 2023

Keywords

ClinConnect Summary

This clinical trial is exploring how effective a specific type of imaging test, called PET-CT, can be in helping doctors understand and treat adults and children with relapsed or refractory B-cell acute lymphoblastic leukemia (ALL). The goal is to see how many patients with this condition can move forward with CAR T-cell therapy, a treatment where the patient’s own immune cells are modified to fight cancer. The PET-CT scans will be done before the CAR T-cell treatment and again at a later date to check for any signs of cancer outside the bone marrow.

To participate in this study, individuals must be between the ages of 5 and 39 and have been diagnosed with relapsed or refractory B-cell ALL. They should also be eligible for CAR T-cell therapy at the National Institutes of Health (NIH). Participants will need to agree to some additional testing, including the PET-CT scans, and may have to pause breastfeeding if applicable. This study is currently recruiting, and it aims to provide better insights into how to improve treatment outcomes for patients with this challenging condition.

Gender

ALL

Eligibility criteria

• * 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)