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

Last updated: April 2, 2026
Sponsor: National Cancer Institute (NCI)
Overall Status: Active - Not Recruiting

Phase

2

Condition

Acute Myeloid Leukemia

Platelet Disorders

Leukemia

Treatment

Laboratory Biomarker Analysis

Computed Tomography

Cytarabine

Clinical Study ID

NCT02392429
NCI-2015-00328
U10CA180827
NCI-2015-00328
U10CA180820
EAi141
EAI141
  • Ages > 18
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Age ≥ 18 years

  • 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)

Study Design

Total Participants: 87
Treatment Group(s): 9
Primary Treatment: Laboratory Biomarker Analysis
Phase: 2
Study Start date:
April 20, 2016
Estimated Completion Date:
February 13, 2027

Study Description

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 post-treatment FLT PET/CT imaging for detecting complete remission.

III. To correlate FLT PET/CT imaging with biologic correlates (minimal residual disease [MRD] assessment) IV. To correlate FLT PET/CT imaging with relapse-free survival and overall survival.

EXPLORATORY OBJECTIVES:

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

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

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. Patients also undergo bone marrow biopsy and aspiration and blood sample collection during screening and on the trial.

After completion of study, patients are followed up at day 28-35, and then up to 1 year beyond the end of study accrual period.

Connect with a study center

  • University of Alabama at Birmingham Cancer Center

    Birmingham, Alabama 35233
    United States

    Site Not Available

  • Mayo Clinic in Rochester

    Rochester, Minnesota 55905
    United States

    Site Not Available

  • Mayo Clinic in Rochester

    Rochester 5043473, Minnesota 5037779 55905
    United States

    Site Not Available

  • Washington University School of Medicine

    Saint Louis, Missouri 63110
    United States

    Site Not Available

  • Washington University School of Medicine

    St Louis, Missouri 63110
    United States

    Site Not Available

  • Washington University School of Medicine

    St Louis 4407066, Missouri 4398678 63110
    United States

    Site Not Available

  • Mount Sinai Hospital

    New York, New York 10029
    United States

    Site Not Available

  • Mount Sinai Hospital

    New York 5128581, New York 5128638 10029
    United States

    Site Not Available

  • UNC Lineberger Comprehensive Cancer Center

    Chapel Hill, North Carolina 27599
    United States

    Site Not Available

  • UNC Lineberger Comprehensive Cancer Center

    Chapel Hill 4460162, North Carolina 4482348 27599
    United States

    Site Not Available

  • University of Oklahoma Health Sciences Center

    Oklahoma City, Oklahoma 73104
    United States

    Site Not Available

  • University of Oklahoma Health Sciences Center

    Oklahoma City 4544349, Oklahoma 4544379 73104
    United States

    Site Not Available

  • Fox Chase Cancer Center

    Philadelphia, Pennsylvania 19111
    United States

    Site Not Available

  • University of Pennsylvania/Abramson Cancer Center

    Philadelphia, Pennsylvania 19104
    United States

    Site Not Available

  • Fox Chase Cancer Center

    Philadelphia 4560349, Pennsylvania 6254927 19111
    United States

    Site Not Available

  • University of Pennsylvania/Abramson Cancer Center

    Philadelphia 4560349, Pennsylvania 6254927 19104
    United States

    Site Not Available

  • Vanderbilt University/Ingram Cancer Center

    Nashville, Tennessee 37232
    United States

    Site Not Available

  • Vanderbilt University/Ingram Cancer Center

    Nashville 4644585, Tennessee 4662168 37232
    United States

    Site Not Available

  • UT Southwestern/Simmons Cancer Center-Dallas

    Dallas, Texas 75390
    United States

    Site Not Available

  • UT Southwestern/Simmons Cancer Center-Dallas

    Dallas 4684888, Texas 4736286 75390
    United States

    Site Not Available

  • Huntsman Cancer Institute/University of Utah

    Salt Lake City, Utah 84112
    United States

    Site Not Available

  • Huntsman Cancer Institute/University of Utah

    Salt Lake City 5780993, Utah 5549030 84112
    United States

    Site Not Available

  • University of Wisconsin Carbone Cancer Center

    Madison, Wisconsin 53792
    United States

    Site Not Available

  • University of Wisconsin Carbone Cancer Center - University Hospital

    Madison, Wisconsin 53792
    United States

    Site Not Available

  • University of Wisconsin Carbone Cancer Center - University Hospital

    Madison 5261457, Wisconsin 5279468 53792
    United States

    Site Not Available

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