FLT PET/CT in Measuring Response in Patients With Previously Untreated Acute Myeloid Leukemia



Status:Active, not recruiting
Conditions:Blood Cancer, Hematology
Therapuetic Areas:Hematology, Oncology
Healthy:No
Age Range:18 - Any
Updated:3/6/2019
Start Date:December 8, 2015

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Early Assessment of Treatment Response in AML Using FLT PET/CT Imaging

This phase II trial studies fluorothymidine F 18 (FLT) positron emission tomography
(PET)/computed tomography (CT) in measuring response in patients with previously untreated
acute myeloid leukemia. FLT is a radioactive substance that may "light up" where cancer is in
the body. FLT is injected into the blood and builds up in cells that are dividing, including
cancer cells. Diagnostic procedures, such as PET/CT, may help measure a patient's response to
earlier treatment.

PRIMARY OBJECTIVES:

I. To evaluate the negative predictive value (NPV) of post-treatment FLT PET/CT imaging for
complete remission (CR) in patients receiving induction chemotherapy for acute myeloid
leukemia (AML).

SECONDARY OBJECTIVES:

I. To evaluate the positive predictive value (PPV) of post-treatment FLT PET/CT imaging for
complete remission.

II. To estimate the sensitivity and specificity of FLT PET/CT at complete remission
detection.

III. To evaluate pre-treatment FLT PET/CT activity as a predictor of complete remission.

IV. To evaluate the change between pre-treatment and post-treatment FLT PET/CT activity as a
predictor of complete remission.

V. To correlate post-treatment FLT PET/CT imaging parameters with day 28 bone marrow
aspirate/biopsy and minimal residual disease assessment by flow cytometry.

VI. To correlate FLT PET/CT imaging parameters (maximum FLT uptake across the total bone
marrow compartment [SUVmax], mean FLT uptake across the total bone marrow compartment
[SUVmean], heterogeneity) with biologic correlates (minimal residual disease [MRD]
assessment).

OUTLINE:

Patients receive anthracycline intravenously (IV) on days 1-3 and cytarabine IV on days 1-7
for up to 2 courses. Patients then undergo FLT PET/CT within 3 days before or after the nadir
bone marrow biopsy (between days 10-17 after initiation of first induction cycle and prior to
reinduction). Patients may undergo an optional FLT PET/CT prior to induction chemotherapy if
it does not interfere with commencement of treatment.

After completion of study, patients are followed up at day 28-35.

Inclusion Criteria:

- Patients must have previously untreated AML and be candidates for intensive induction
chemotherapy; patients are allowed to have had prior hydroxyurea

- Patients must not have acute promyelocytic leukemia (APL) and must not have evidence
of t(15;17)(q22;q21)

- Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of
0-3 (restricted to ECOG performance status [PS] 0-2 if age > 70 years)

- Patients must have left ventricular ejection fraction (LVEF) > 45% or within
institutional normal limits

- Patients must be able to lie still for a 1.5 hour PET scan

- Patient must NOT have a history of allergic reaction attributable to compounds of
similar chemical or biologic composition to 18F-fluorothymidine

- Patient must NOT weigh more than the maximum weight limit for the PET/CT table for the
scanner(s) to be used at each center

- The patient is participating in the trial at an institution which has agreed to
perform the imaging research studies, completed the ECOG-American College of Radiology
Imaging Network (ACRIN) defined scanner qualification procedures and received
ECOG-ACRIN approval as outlined

- Women must not be pregnant or breast-feeding; all females of childbearing potential
must have a blood test or urine study within 2 weeks prior to registration to rule out
pregnancy; a female of childbearing potential is any woman, regardless of sexual
orientation or whether they have undergone tubal ligation, who meets the following
criteria: 1) has not undergone a hysterectomy or bilateral oophorectomy; or 2) has not
been naturally postmenopausal for at least 24 consecutive months (i.e., has had menses
at any time in the preceding 24 consecutive months)
We found this trial at
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sites
600 Highland Ave
Madison, Wisconsin 53792
(608) 263-6400
Principal Investigator: Ryan J. Mattison
Phone: 800-622-8922
University of Wisconsin Hospital and Clinics UW Health strives to meet the health needs of...
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Birmingham, Alabama 35233
Principal Investigator: Jonathan E. McConathy
Phone: 205-934-0220
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Chapel Hill, North Carolina 27599
Principal Investigator: Matthew C. Foster
Phone: 877-668-0683
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Dallas, Texas 75390
Principal Investigator: Rathan M. Subramaniam
Phone: 214-648-7097
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Nashville, Tennessee 37232
Principal Investigator: Stephen A. Strickland
Phone: 800-811-8480
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New York, New York 10029
Principal Investigator: Lale Kostakoglu
Phone: 212-824-7309
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940 NE 13th St
Oklahoma City, Oklahoma 73190
(405) 271-6458
Principal Investigator: Jennifer L. Holter-Chakrabarty
Phone: 405-271-8777
University of Oklahoma Health Sciences Center The OU Health Sciences Center is composed of seven...
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Philadelphia, Pennsylvania 19104
Principal Investigator: David A. Mankoff
Phone: 800-474-9892
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Philadelphia, Pennsylvania 19111
Principal Investigator: Patricia L. Kropf
Phone: 215-728-4790
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Rochester, Minnesota 55905
Principal Investigator: Kebede H. Begna
Phone: 855-776-0015
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660 S Euclid Ave
Saint Louis, Missouri 63110
(314) 362-5000
Principal Investigator: Barry A. Siegel
Phone: 800-600-3606
Washington University School of Medicine Washington University Physicians is the clinical practice of the School...
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2000 Circle of Hope Dr
Salt Lake City, Utah 84112
(801) 585-0303
Principal Investigator: Tibor J. Kovacsovics
Phone: 888-424-2100
Huntsman Cancer Institute at University of Utah Huntsman Cancer Institute (HCI) is part of the...
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