Pilot Imaging Study of Leukemia

NCT ID: NCT03633955

Last Updated: 2025-02-24

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE1
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-01-19
• Study Completion Date: 2028-04-30

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.

Detailed Description

This prospective trial is designed to evaluate whether investigational 18F FLT imaging can identify the burden of hematopoietic disease both subjectively (by pattern of hematopoiesis in medullary spaces) and objectively (by SUV determination).

Patients undergoing therapy for treatment of high-risk acute leukemia or myeloma will be eligible for this study. Patients may or may not have undergone myeloablative hematopoietic stem cell transplantation. Two cohorts will be accrued: patients with high risk acute leukemia and patients with myeloma. In each cohort, patients will be accrued under two arms: Arm A - patients receiving immunotherapy and Arm B - patients who are receiving standard therapy (not immunotherapy or bone marrow transplant). Therefore, the leukemia cohort will consist of patients accrued in Arm A-L (immunotherapy) or in Arm B-L (standard therapy), and the myeloma cohort will consist of patients accrued in Arm A-M (immunotherapy) or in Arm B-M (standard therapy). Because patients with high risk acute leukemia or myeloma have poor prognosis with high risk for relapse, novel ways to evaluate the success of therapies would be valuable. 18F FLT reveals hematopoietic cell proliferation and can identify residual leukemia disease. On this trial, patients will undergo 18F FLT imaging pre-therapy and during a follow-up visit post-therapy. Patients in both cohorts will be imaged (Termed baseline scan) within one week prior to receiving respective therapies (e.g. immunotherapy or standard therapy) and then imaged approximately 28 days (+/-3 days) after the therapy termed Follow-up scan. After treatment, weekly follow-ups will be conducted for these patients till the follow-up scan (28 days +/-3 days) and then the final follow-up will be conducted post-1-year (after the start of immunotherapy or standard therapy).

Conditions

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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Standard therapy - Acute leukemia cohort

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

Group Type: ACTIVE_COMPARATOR

FLT

Intervention Type: DRUG

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

Immunotherapy - Acute leukemia cohort

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

Group Type: EXPERIMENTAL

FLT

Intervention Type: DRUG

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

Standard therapy - Myeloma cohort

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

Group Type: ACTIVE_COMPARATOR

FLT

Intervention Type: DRUG

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

Immunotherapy - Myeloma cohort

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

Group Type: EXPERIMENTAL

FLT

Intervention Type: DRUG

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

Interventions

FLT

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

Intervention Type: DRUG

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.

• Minimum Eligible Age: 4 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Oklahoma

OTHER

Sponsor Role: lead

Emory University

OTHER

Sponsor Role: collaborator

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jennifer Holter, MD

Role: PRINCIPAL_INVESTIGATOR

Stephenson Cancer Center

Locations

Children's National Health System

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

Site Status: WITHDRAWN

Emory University

Atlanta, Georgia, United States

Site Status: NOT_YET_RECRUITING

University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Heme Onc Lead Nurse

Role: CONTACT

SCC-IIT-Office@ouhsc.edu

1-405-271-8777

Facility Contacts

Kirsten M Williams, MD

Role: primary

Jennifer Holter Chakrabarty, MD

Role: primary

jholter2@ouhsc.edu

405-271-4022

Other Identifiers

OU-SCC-REALIZE

Identifier Type: -

Identifier Source: org_study_id