REALIZE: Pilot Imaging Study of Leukemia

Sponsor
University of Oklahoma (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT03633955
Collaborator
Emory University (Other)
36
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Study Details

Study Description

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, secondary endpoint). Because patients with high risk acute leukemia, CML, and MDS have poor prognosis with high risk for relapse, novel ways to evaluate the success of therapies would be valuable. 18F FLT is 3'-deoxy-3 18F-fluorothymidine, a radiolabeled thymidine analogue, reveals hematopoietic cell proliferation, and can identify residual leukemia disease.

This study will enroll patients onto two arms:

For Group A Patients (post immunotherapy with co-enrollment on separate protocol or other immunotherapy): Patients will be imaged within one week prior to receiving immunotherapy: termed Baseline Scan and then imaged approximately 28 days after immunotherapy (+14/-7 days after therapy) termed Follow-up scan.

For Group B Patients (after other therapies): Patients will receive their baseline scans within one week prior to starting cancer therapy and their follow up scan 28 days after cancer therapy (+14/-7 days).

Baseline 18F FLT scans will be obtained within 14 days of standard of care clinical restaging and up to 7 days prior to initiating either immunotherapy (arm A) or standard cancer therapy (arm B). Patients will then receive scheduled treatment plan. Patients will receive scheduled clinical follow-up with clinical restaging bone marrow tests and if clinically indicated, restaging with CNS evaluation, or other tests such as PET/CT for evaluation of extramedullary disease.

Follow-up will occur weekly to assess for toxicities of 18F FLT imaging for 4 weeks. The follow up 18F FLT image will occur 4-8 weeks after initiation of treatment for the cancer and is planned to occur at the time of clinical restaging for response to therapy (+ 14 days/-7 days).

Patients will also undergo sampling for blood biomarkers of residual disease and immune activity against disease. Finally, patients will report symptoms and quality of life measures using the PROMIS measures.

Patients will be recruited from the blood and marrow transplant and oncology clinics at institutions by the treating physicians who may identify whether this study is appropriate to bring to the attention of the patient and/or his or her guardians.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
36 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
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.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.
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
Multi-institutional Prospective Pilot Study of Radiology Evaluation of Acute Leukemia Infiltration analyZed by Experimental Imaging
Anticipated Study Start Date :
May 1, 2022
Anticipated Primary Completion Date :
Jan 1, 2024
Anticipated Study Completion Date :
Feb 1, 2026

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Standard therapy

This Arm will accrue patients receiving standard therapy (e.g. chemotherapy for leukemia).

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

Experimental: Immunotherapy

The other Arm will include patients receiving immunotherapy

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

Outcome Measures

Primary Outcome Measures

  1. FLT SUV identifies leukemia disease [day -7 and +28]

    To calculate if SUV change from baseline identifies residual leukemia disease burden

Secondary Outcome Measures

  1. Computer assisted evaluation of leukemia disease [day -7, and +28]

    To use computer algorithm to calculate if SUV changes from baseline in marrow spaces and correlates with clinical disease burden of leukemia

  2. Patient reported outcomes [Day -7, and +28]

    To calculate if the scores on patient reported outcome measures are lower re: pain and anxiety with imaging than marrow tests

  3. Blood biomarkers [Day -7, and +28]

    Calculate if WT1 and other biomarker values changes from baseline correlate with leukemia disease burden by clinical assessments

Eligibility Criteria

Criteria

Ages Eligible for Study:
4 Years to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Aged 4 to 80 years

  • Evidence of high risk hematopoietic malignancy with relapsed/refractory disease and/or high risk for relapse.

o Acute lymphocytic leukemia, Acute myeloid leukemia, Chronic myelogenous leukemia, Ambiguous lineage leukemia or lymphoma, or myelodysplastic syndrome

  • 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.

  • 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 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:
  • Patients with uncontrolled infections

  • Pregnancy or lactating

  • History of prior fluorothymidine allergy or intolerance

Contacts and Locations

Locations

Site City State Country Postal Code
1 Children's National Health System Washington District of Columbia United States 20010
2 Emory University Atlanta Georgia United States 30322
3 University of Oklahoma Health Sciences Center Oklahoma City Oklahoma United States 73117

Sponsors and Collaborators

  • University of Oklahoma
  • Emory University

Investigators

  • Principal Investigator: Jennifer Holter, MD, Stephenson Cancer Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University of Oklahoma
ClinicalTrials.gov Identifier:
NCT03633955
Other Study ID Numbers:
  • OU-SCC-REALIZE
First Posted:
Aug 16, 2018
Last Update Posted:
Feb 22, 2022
Last Verified:
Feb 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by University of Oklahoma
Additional relevant MeSH terms:

Study Results

No Results Posted as of Feb 22, 2022