Imaging study to evaluate leukemia treatment response

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This pilot study aims to assess whether 18F FLT imaging can detect abnormalities in hematopoietic malignancies, specifically in patients with high-risk acute leukemia or myeloma. Participants will undergo imaging before and after therapy to evaluate the correlation between imaging signals and clinically validated evidence of disease. The study includes two cohorts: one receiving immunotherapy and the other receiving standard therapy. The goal is to identify residual disease and improve treatment evaluation methods for these high-risk patients.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Aged 4 to 80 years
2. Evidence of high-risk hematopoietic malignancy with relapsed/refractory disease: acute lymphocytic leukemia, Acute myeloid leukemia, Ambiguous lineage leukemia, myeloma
3. Karnofsky/Lansky score of ≥ 50
4. Agree to use contraceptive measures during study protocol participation (when age appropriate)
5. Patient or parent/guardian capable of providing informed consent.
6. Ability to undergo 18F FLT imaging without sedation
7. Bilirubin \< 2.5 mg/dL, AST/ALT \<5x upper limit of normal, Serum creatinine \< 1.0 or 2x the upper limit of normal (whichever is higher)
8. Pulse oximetry of \> 90% on room air
9. Ability to undergo 18F FLT imaging without sedation
10. Anticipated immunotherapy (Arm A to include patients who received immune therapy with co-enrollment on a separate protocol or other immunotherapy) and Arm B, those who received other non-immune therapies to treat their cancers (excludes HSCT but includes chemotherapy or non-HSCT radiotherapy).

Exclusion Criteria:

1. Patients with uncontrolled infections
2. Pregnancy or lactating
3. History of prior fluorothymidine allergy or intolerance.

Where it's running

• University of Oklahoma Health Sciences Center
  Oklahoma City, Oklahoma, United States Recruiting
• Children's National Health System
  Washington D.C., District of Columbia, United States Withdrawn
• Emory University
  Atlanta, Georgia, United States Not yet recruiting

Study contacts

• Principal investigator: Jennifer Holter, MD — Stephenson Cancer Center
• Study coordinator: Heme Onc Lead Nurse
• Email: SCC-IIT-Office@ouhsc.edu
• Phone: 1-405-271-8777

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.