Imaging study to evaluate leukemia treatment response

Multi-institutional Prospective Pilot Study of Radiology Evaluation of Acute Leukemia Infiltration analyZed by Experimental Imaging

This study is testing if a special type of imaging can help doctors see how well treatments are working for people with high-risk acute leukemia or myeloma.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 60 (estimated)
• Ages: 4 Years to 80 Years
• Sex: All
• Sponsor: University of Oklahoma (Academic / other)
• Drugs / interventions: chemotherapy, immunotherapy
• Locations: 3 sites (Washington D.C., District of Columbia and 2 other locations)
• Trial ID: NCT03633955 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are patients aged 4 to 80 with high-risk hematopoietic malignancies, including acute lymphocytic leukemia, acute myeloid leukemia, ambiguous lineage leukemia, or myeloma.

Not a fit: Patients with low-risk hematopoietic malignancies or those who cannot undergo 18F FLT imaging without sedation may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could enhance the ability to monitor treatment response in patients with high-risk leukemia and myeloma, potentially leading to better management of their conditions.

How similar studies have performed: While this approach is novel in its specific application, similar imaging techniques have shown promise in evaluating treatment responses in other hematologic malignancies.

Eligibility criteria

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 this trial is running

Washington D.C., District of Columbia and 2 other locations

• Children's National Health System — Washington D.C., District of Columbia, United States (Withdrawn)
• Emory University — Atlanta, Georgia, United States (Not_yet_recruiting)
• University of Oklahoma Health Sciences Center — Oklahoma City, Oklahoma, United States (Recruiting)

Study contacts

• Principal investigator: Jennifer Holter, MD — Stephenson Cancer Center
• Study coordinator: Heme Onc Lead Nurse

Conditions Acute Lymphocytic Leukemia; Acute Myeloid Leukemia; Ambiguous Lineage Leukemia or Lymphoma; Myeloma; FLT