Pilot Imaging Study of Leukemia



Status:Not yet recruiting
Conditions:Other Indications, Blood Cancer
Therapuetic Areas:Oncology, Other
Healthy:No
Age Range:4 - 80
Updated:3/28/2019
Start Date:April 1, 2019
End Date:July 2023

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

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.

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).

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
We found this trial at
2
sites
940 NE 13th St
Oklahoma City, Oklahoma 73190
(405) 271-6458
Phone: 405-271-4022
University of Oklahoma Health Sciences Center The OU Health Sciences Center is composed of seven...
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Oklahoma City, OK
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Washington, District of Columbia 20010
Principal Investigator: Kirsten Williams, MD
Phone: 202-476-4952
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Washington,
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