Pilot Imaging Study of Leukemia

NCT03633955 | Recruiting Phase 1 DMC FDA Drug

• 1 other identifier: OU-SCC-REALIZE
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 3

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

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

Keywords

FLT

Outcome Measures

Primary Outcomes (3)

• Proportion of 18F FLT signal uptake abnormalities with clinical pathology reports for determining the evidence of hematopoietic disease.

  A proportion of patients will undergo 18F FLT imaging before and after immunotherapy or standard therapy for hematopoietic malignant disease. To detect changes in the progression of hematopoietic disease 18F FLT image scans collected pre-treatment (baseline) and post-treatment (follow-up) of patient visit at OUHSC will be compared with clinically validated evidence of hematopoietic malignant disease collected using MRD, molecular, flow and histology techniques.

  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.

  For proportion of patient the analyses will be compared between two Arms of disease cohort. Arm A to include patients who received immunotherapy (immunotherapy protocol co-enrollment or other immunotherapy), and Arm B: those who received other non-immune therapies to treat their cancers (excludes HSCT). For marrow disease, the intra-medullary pattern and standard unit of uptake (SUV) will be compared pre- and post-treatment between patients in remission clinically versus those with greater disease burden, to determine if 18F FLT uptake correlates with identified clinical relapse.

  day -7 to 10 days pre-treatment and +28 (+/- 3 days) post-treatment

• Mean differences of 18F FLT uptake to determine extramedullary disease.

  For proportion of patient undergoing 18F FLT scan, the extramedullary disease will be identified by comparing the SUV and size of lesions pre- and post-treatment. The comparisons will be done in two arms of disease cohort Arm A, i.e., to include patients who received immunotherapy (immunotherapy protocol co-enrollment or other immunotherapy), and Arm B: those who received other non-immune therapies to treat their cancers (excludes HSCT).

  day -7 to 10 days pre-treatment and +28 (+/- 3 days) post-treatment

Study Arms (4)

Standard therapy - Acute leukemia cohort

ACTIVE COMPARATOR

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

Drug: FLT

Immunotherapy - Acute leukemia cohort

EXPERIMENTAL

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

Drug: FLT

Standard therapy - Myeloma cohort

ACTIVE COMPARATOR

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

Drug: FLT

Immunotherapy - Myeloma cohort

EXPERIMENTAL

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

Drug: FLT

Interventions

FLT DRUG

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

Immunotherapy - Acute leukemia cohort; Immunotherapy - Myeloma cohort; Standard therapy - Acute leukemia cohort; Standard therapy - Myeloma cohort

Eligibility Criteria

• Age: 4 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged 4 to 80 years
• Evidence of high-risk hematopoietic malignancy with relapsed/refractory disease: acute lymphocytic leukemia, Acute myeloid leukemia, Ambiguous lineage leukemia, myeloma
• Karnofsky/Lansky score of ≥ 50
• Agree to use contraceptive measures during study protocol participation (when age appropriate)
• Patient or parent/guardian capable of providing informed consent.
• Ability to undergo 18F FLT imaging without sedation
• 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)
• Pulse oximetry of \> 90% on room air
• Ability to undergo 18F FLT imaging without sedation
• 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).

You may not qualify if:

• Patients with uncontrolled infections
• Pregnancy or lactating
• History of prior fluorothymidine allergy or intolerance.

Sponsors & Collaborators

• University of Oklahoma: lead
• Emory University: collaborator

Study Sites (3)

Children's National Health System

Washington D.C., District of Columbia, 20010, United States

WITHDRAWN

Emory University

Atlanta, Georgia, 30322, United States

NOT YET RECRUITING

University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, 73117, United States

RECRUITING

MeSH Terms

Conditions

Precursor Cell Lymphoblastic Leukemia-Lymphoma; Leukemia, Myeloid, Acute; Lymphoma; Neoplasms, Plasma Cell

Condition Hierarchy (Ancestors)

Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Leukemia, Myeloid

Study Officials

• Jennifer Holter, MD

  Stephenson Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Heme Onc Lead Nurse

CONTACT

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

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a prospective pilot study, the primary aim of which is to determine whether the abnormalities in 18F FLT imaging signal uptake correlate with clinically validated evidence of hematopoietic malignant disease (e.g. MRD, molecular, flow or histology) after immunotherapy and other treatments.

Study Record Dates

• First Submitted: August 9, 2018
• First Posted: August 16, 2018
• Study Start: January 19, 2023
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): April 1, 2029
• Last Updated: April 23, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)