Recruiting

Phase 1

Observational StudyPilot Imaging Study of Leukemia

Sponsor:

University of Oklahoma

Code:

NCT03633955

Conditions

Acute Lymphocytic Leukemia

Acute Myeloid Leukemia

Ambiguous Lineage Leukemia or Lymphoma

Myeloma

Eligibility Criteria

Sex: All

Age: 4 - 70+

Healthy Volunteers: Not accepted

Interventions

FLT

Study Details

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.

Conditions

Acute Lymphocytic Leukemia

Acute Myeloid Leukemia

Ambiguous Lineage Leukemia or Lymphoma

Myeloma

Study ID

NCT03633955

Start date

Jan 19, 2023

Status verified date

Apr, 2026

Completion date

Apr, 2029

Anticipated

Primary completion date

Apr, 2027

Anticipated

Eligibility Criteria

Sex: All

Age: 4 - 70+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

60 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

active comparator: Standard therapy - Acute leukemia cohort

The Arm will accrue patients receiving standard therapy from the high-risk acute leukemia cohort (18 patients).

experimental: Immunotherapy - Acute leukemia cohort

The Arm will accrue patients receiving immunotherapy from the high-risk acute leukemia cohort (18 patients).

active comparator: Standard therapy - Myeloma cohort

The Arm will accrue patients receiving standard therapy from the myeloma cohort (9 patients).

experimental: Immunotherapy - Myeloma cohort

The Arm will accrue patients receiving immunotherapy from the myeloma cohort (9 patients).

Interventions

FLT

F18 labeled thymidine PET/CT scans will be performed before and after patient receives therapies.

Primary outcome measure

Proportion of 18F FLT signal uptake abnormalities with clinical pathology reports for determining the evidence of hematopoietic disease. [ Time Frame: day -7 to 10 days pre-treatment and +28 (+/- 3 days) post-treatment ]
A proportion of 18F FLT uptake in a standard region of interest in marrow to objectively identify disease status in patient with hematopoietic cancers. [ Time Frame: day -7 to 10 days pre-treatment and +28 (+/- 3 days) post-treatment ]
Mean differences of 18F FLT uptake to determine extramedullary disease. [ Time Frame: day -7 to 10 days pre-treatment and +28 (+/- 3 days) post-treatment ]

Central Contacts and Locations

Central contacts

Heme Onc Lead Nurse

1-405-271-8777 SCC-IIT-Office@ouhsc.edu

Locations

University of Oklahoma Health Sciences Center

Recruiting

Oklahoma City, Oklahoma, United States, 73117

Contacts

Jennifer Holter Chakrabarty, MD

405-271-4022 jholter2@ouhsc.edu

More Information

Sponsor

University of Oklahoma

Last update posted

Apr 23, 2026

Last verified

Apr, 2026

Keywords

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by University of Oklahoma on 2026-04-23.