CompletedNot Applicable

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

United States10 participantsStarted 2023-08-25

Plain-language 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....

Who can participate

Age range

5 Years – 39 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

* 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)

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Since this trial is already completed, would it be possible to see the results — specifically what proportion of patients had disease outside the central nervous system detected by PET-CT before their CAR T-cell therapy, and how that might affect my own treatment planning?
2For someone with relapsed or refractory B-cell ALL like me, how important is it to detect disease spread beyond the bone marrow and blood before starting CAR T-cell therapy, and could a PET-CT scan change the recommended treatment approach?
3This was described as a pilot study with no assigned phase — does that mean the findings are still considered preliminary, and should I be cautious about how much weight to put on them when thinking about my own care?
4If PET-CT imaging revealed hidden sites of disease in some patients in this study, is there a standard-of-care imaging protocol you'd recommend for me before we discuss CAR T-cell therapy, and would it be similar to what was done here?
5Are there other completed or ongoing studies building on this pilot that might be relevant to my situation with relapsed or refractory B-cell ALL, especially regarding how imaging results influence CAR T-cell therapy decisions?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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

Timeframe: 3 months

Trial details

NCT IDNCT05969002

SponsorNational Cancer Institute (NCI)

Sponsor typeNIH

Study typeOBSERVATIONAL

Primary completion2025-12-01

View on ClinicalTrials.gov More B Cell trials