Pilot Imaging Study of Leukemia

Launched by UNIVERSITY OF OKLAHOMA · Aug 14, 2018

Keywords

ClinConnect Summary

This clinical trial is looking at a new imaging method to help doctors understand how well certain treatments are working for patients with types of blood cancers, such as acute lymphocytic leukemia, acute myeloid leukemia, and myeloma. The main goal is to see if changes spotted in the imaging can help identify the presence of cancer cells after patients have received treatment, especially immunotherapy, which helps the immune system fight cancer.

To participate in this study, patients need to be between 4 and 80 years old and have a specific type of blood cancer that is considered high-risk and has not responded to previous treatments. They should also be able to undergo imaging without sedation and meet certain health criteria, such as having a stable liver and kidney function. Throughout the study, participants will have the opportunity to receive either immunotherapy or other treatments, and their progress will be closely monitored. It's important for potential participants and their families to know that this is a research study, which means that while the goal is to gather valuable information, the outcomes may vary.

Gender

ALL

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.