NCT03633955 Pilot Imaging Study of Leukemia
| NCT ID | NCT03633955 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | University of Oklahoma |
| Condition | Acute Lymphocytic Leukemia |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2023-01-19 |
| Primary Completion | 2027-04 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 60 participants in total. It began in 2023-01-19 with a primary completion date of 2027-04.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This is a prospective pilot study, the primary aim of which is to determine whether the presence of 18F FLT imaging signal uptake abnormalities correlate with clinically validated evidence of hematopoietic malignant disease (e.g. MRD, molecular, flow or histology) after immunotherapy and other treatments.
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.
Contact & Investigator
Jennifer Holter, MD
PRINCIPAL INVESTIGATOR
Stephenson Cancer Center
Frequently Asked Questions
Who can join the NCT03633955 clinical trial?
This trial is open to participants of all sexes, aged 4 Years or older, up to 80 Years, studying Acute Lymphocytic Leukemia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT03633955 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT03633955 currently recruiting?
Yes, NCT03633955 is actively recruiting participants. Contact the research team at SCC-IIT-Office@ouhsc.edu for enrollment information.
Where is the NCT03633955 trial being conducted?
This trial is being conducted at Washington D.C., United States, Atlanta, United States, Oklahoma City, United States.
Who is sponsoring the NCT03633955 clinical trial?
NCT03633955 is sponsored by University of Oklahoma. The principal investigator is Jennifer Holter, MD at Stephenson Cancer Center. The trial plans to enroll 60 participants.
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