Using PET-CT imaging to assess relapsed/refractory acute leukemias before CAR T-cell therapy
Pilot Prospective Study for PET-CT Imaging in Participants With Relapsed/Refractory Acute Leukemias
This study is testing if a special type of imaging can help find hidden cancer in kids and young adults with relapsed B-cell leukemia before they receive CAR T-cell therapy.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 36 (estimated) |
| Ages | 5 Years to 39 Years |
| Sex | All |
| Sponsor | National Institutes of Health Clinical Center (CC) NIH |
| Drugs / interventions | CAR T, chimeric antigen receptor |
| Locations | 1 site (Bethesda, Maryland) |
| Trial ID | NCT05969002 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate the effectiveness of 18-fludeoxyglucose (18F-FDG) positron emission tomography-computed tomography (PET-CT) imaging in detecting non-central nervous system extramedullary disease (EMD) in adults and children with relapsed/refractory B-cell acute lymphoblastic leukemia (ALL) who are being considered for CAR T-cell therapy. The study will track the number of participants who proceed to CAR T-cell therapy and assess the impact of pre-therapy imaging on treatment outcomes. Participants will include those aged 5-39 years with specific clinical indications for PET-CT imaging prior to CAR infusion.
Who should consider this trial
Good fit: Ideal candidates are individuals aged 5-39 years with relapsed/refractory B-cell ALL who are being screened for CAR T-cell therapy.
Not a fit: Patients without relapsed/refractory B-cell ALL or those who do not meet the specific clinical indications for PET-CT imaging may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve the identification of patients at risk for poor outcomes, leading to more tailored and effective treatment strategies.
How similar studies have performed: While this approach is novel in the context of ALL, similar imaging techniques have shown promise in other hematological malignancies, suggesting potential for success.
Eligibility criteria
Show full inclusion / exclusion 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)
Where this trial is running
Bethesda, Maryland
- National Institutes of Health Clinical Center — Bethesda, Maryland, United States (Recruiting)
Study contacts
- Principal investigator: Nirali N Shah, M.D. — National Cancer Institute (NCI)
- Study coordinator: NCI Pediatric Leukemia, Lymphoma Transpl
- Email: ncilltct@mail.nih.gov
- Phone: (240) 760-6970
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.