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Pilot Imaging Study of Leukemia (REALIZE)

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ClinicalTrials.gov Identifier: NCT03633955
Recruitment Status : Not yet recruiting
First Posted : August 16, 2018
Last Update Posted : June 17, 2019
Sponsor:
Collaborator:
Children's Research Institute
Information provided by (Responsible Party):
Kirsten Williams, Children's Research Institute

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.

Patients undergoing therapy for treatment of high risk acute leukemia or chronic myelogenous leukemia (CML) or myelodysplastic syndrome (MDS) will be eligible for this study. Patients may or may not have undergone myeloablative hematopoietic stem cell transplantation. Two cohorts will be accrued. One cohort will accrue patients receiving standard therapy (not immunotherapy or bone marrow transplant). The other cohort will include patients who are also receiving Tumor Antigen Associated Lymphocytes (TAA-L) and will be co-enrolled on a separate protocol RESOLVE. RESOLVE trial has shown safety and tolerability at the first 3 dose levels after hematopoietic stem cell transplantation, and in 2 patients at the top dose level at the time of REALIZE submission. 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. We have previously shown safety of 18F FLT imaging for patients undergoing hematopoietic stem cell transplantation and safety has been shown for pediatric patients with brain tumors undergoing therapies. On this trial, patients will undergo 18F FLT imaging pre-therapy and during a follow-up visit between Day 21 and 42 per appendix F (+14/-7) post-therapy. Patients will also undergo standard of care evaluation of disease. 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.


Condition or disease Intervention/treatment
Acute Leukemia Drug: FLT imaging

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).

This study will enroll patients onto two arms:

For Group A Patients (post TAA-L cells or other immunotherapy): Patients will be imaged within one week prior to receiving TAA-L cells: termed Baseline Scan and then imaged 28 days after cellular therapy infusion (+14/-7 after infusion of cellular therapy) termed Follow-up scan.

For Group B Patients (after other therapies): Patients will be imaged within one week prior to starting cancer therapy: termed Baseline Scan and then imaged 28 days after cancer therapy termed Follow-up scan as per appendix F (+14/-7 from start of chemotherapy or radiotherapy regimen).

All scans will be coded and analyzed centrally at University of Oklahoma.

Patients will be recruited from the blood and marrow transplant and oncology clinics at both 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.

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). Note: standard of care clinical restaging includes the tests performed to evaluate the cancer disease (e.g. bone marrow, lumbar puncture, clinical imaging tests). Patients will then receive scheduled treatment plan (Arm A TAA-L infusion, Arm B other treatments). For patients receiving TAA-L cells at Children's National Medical Center but imaging at University of Oklahoma, the baseline scan will be performed, the patient will travel to Children's for the infusion and then the patient will receive follow-up scan at University of Oklahoma. Patients will receive scheduled clinical follow-up with clinical restaging bone marrow tests (to include minimal residual disease testing by flow and if applicable also by PCR or FISH modalities), 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 next (and final) 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/-5 days).


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Study Type : Observational
Estimated Enrollment : 36 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Multi-institutional Prospective Pilot Study of Radiology Evaluation of Acute Leukemia Infiltration analyZed by Experimental Imaging
Estimated Study Start Date : August 1, 2019
Estimated Primary Completion Date : September 2022
Estimated Study Completion Date : July 2023

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Standard therapy
This Arm will accrue patients receiving standard therapy (e.g. chemotherapy for leukemia).
Drug: FLT imaging
F18 labeled thymidine PET/CT scans will be performed before and after patient receives therapies.

Immunotherapy
The other Arm will include patients receiving immunotherapy
Drug: FLT imaging
F18 labeled thymidine PET/CT scans will be performed before and after patient receives therapies.




Primary Outcome Measures :
  1. FLT SUV identifies leukemia disease [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: Day -7, and +28 ]
    Calculate if WT1 and other biomarker values changes from baseline correlate with leukemia disease burden by clinical assessments



Information from the National Library of Medicine

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Ages Eligible for Study:   4 Years to 80 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with hematologic malignancies undergoing therapies.
Criteria

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 immune therapy with TAA-L cells (RESOLVE co-enrollment) 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:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03633955


Locations
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United States, District of Columbia
Children's National Health System Recruiting
Washington, District of Columbia, United States, 20010
Contact: Fahmida Hoq, MBBS, MS    202-476-3634    fhoq@childrensnational.org   
Children's National Health System Recruiting
Washington, District of Columbia, United States, 20010
Contact: Kirsten Williams, MD    202-476-4952    kmwillia@childrensnational.org   
Principal Investigator: Kirsten Williams, MD         
United States, Oklahoma
University of Oklahoma Health Sciences Center Not yet recruiting
Oklahoma City, Oklahoma, United States, 73117
Contact: Jennifer Holter Chakrabarty, MD    405-271-4022    jholter2@ouhsc.edu   
Sponsors and Collaborators
Kirsten Williams
Children's Research Institute

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Responsible Party: Kirsten Williams, Attending Physician, BMT and Scientific Director, PCI, Children's Research Institute
ClinicalTrials.gov Identifier: NCT03633955     History of Changes
Other Study ID Numbers: Pro00010091
First Posted: August 16, 2018    Key Record Dates
Last Update Posted: June 17, 2019
Last Verified: June 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Leukemia
Neoplasms by Histologic Type
Neoplasms