Pilot Imaging Study of Leukemia

Acute Myeloid Leukemia Clinical Trial

— REALIZE  

Official title:

Multi-institutional Prospective Pilot Study of Radiology Evaluation of Acute Leukemia Infiltration analyZed by Experimental Imaging

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03633955
• Other study ID #: OU-SCC-REALIZE
• Status: Recruiting
• Phase: Phase 1
• Start date: January 19, 2023
• Est. completion date: April 2027

Study information

• Verified date: February 2024
• Source: University of Oklahoma
• Contact: Heme Onc Lead Nurse
• Phone: 1-405-271-8777
• Email: SCC-IIT-Office[@]ouhsc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: April 2027
• Est. primary completion date: March 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 4 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Acute Lymphocytic Leukemia
• Acute Myeloid Leukemia
• Ambiguous Lineage Leukemia or Lymphoma
• Leukemia
• Myeloma
• Precursor Cell Lymphoblastic Leukemia-Lymphoma

Intervention

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

Locations

Country	Name	City	State
United States	Emory University	Atlanta	Georgia
United States	University of Oklahoma Health Sciences Center	Oklahoma City	Oklahoma
United States	Children's National Health System	Washington	District of Columbia

Sponsors (2)

Lead Sponsor	Collaborator
University of Oklahoma	Emory University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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