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

NCT02392429

Description:

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.

Related Conditions:
  • Acute Myeloid Leukemia
Recruiting Status:

Active, not recruiting

Phase:

Phase 2

Trial Eligibility

Document

Title

  • Brief Title: FLT PET/CT in Measuring Response in Patients With Previously Untreated Acute Myeloid Leukemia
  • Official Title: Early Assessment of Treatment Response in AML Using FLT PET/CT Imaging

Clinical Trial IDs

  • ORG STUDY ID: NCI-2015-00328
  • SECONDARY ID: NCI-2015-00328
  • SECONDARY ID: EAI141
  • SECONDARY ID: EAI141
  • SECONDARY ID: EAI141
  • SECONDARY ID: U10CA180820
  • SECONDARY ID: U10CA180827
  • NCT ID: NCT02392429

Conditions

  • Acute Myeloid Leukemia
  • Untreated Adult Acute Myeloid Leukemia

Interventions

DrugSynonymsArms
ChemotherapyChemo, Chemotherapy (NOS), Chemotherapy, Cancer, GeneralDiagnostic (anthracycline, cytarabine, FLT PET/CT)
Cytarabine.beta.-Cytosine arabinoside, 1-.beta.-D-Arabinofuranosyl-4-amino-2(1H)pyrimidinone, 1-.beta.-D-Arabinofuranosylcytosine, 1-Beta-D-arabinofuranosyl-4-amino-2(1H)pyrimidinone, 1-Beta-D-arabinofuranosylcytosine, 1.beta.-D-Arabinofuranosylcytosine, 2(1H)-Pyrimidinone, 4-Amino-1-beta-D-arabinofuranosyl-, 2(1H)-Pyrimidinone, 4-amino-1.beta.-D-arabinofuranosyl-, Alexan, Ara-C, ARA-cell, Arabine, Arabinofuranosylcytosine, Arabinosylcytosine, Aracytidine, Aracytin, Aracytine, Beta-cytosine Arabinoside, CHX-3311, Cytarabinum, Cytarbel, Cytosar, Cytosine Arabinoside, Cytosine-.beta.-arabinoside, Cytosine-beta-arabinoside, Erpalfa, Starasid, Tarabine PFS, U 19920, U-19920, Udicil, WR-28453Diagnostic (anthracycline, cytarabine, FLT PET/CT)

Purpose

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.

Detailed 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 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.
    

Trial Arms

NameTypeDescriptionInterventions
Diagnostic (anthracycline, cytarabine, FLT PET/CT)ExperimentalPatients receive anthracycline 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.
  • Chemotherapy
  • Cytarabine

Eligibility Criteria

        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)
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Negative predictive value of post-treatment FLT PET/CT imaging for CR in comparison with blast counts from bone marrow biopsy (BMBX)
Time Frame:Up to day 35
Safety Issue:
Description:Three imaging parameters (SUVmean, SUVmax, heterogeneity of FLT uptake [SUVhetero]) will be measured from an FLT PET/CT scan and SUVmax will be the primary endpoint. The binomial proportion of PPV and the corresponding Exact confidence intervals will be calculated. In addition, the calculated NPV will be tested against the null hypothesis to see if it's significantly larger than 0.64 (NPV of day-14 BMBX in CR prediction).

Secondary Outcome Measures

Measure:PPV of post-treatment FLT PET/CT imaging for complete remission
Time Frame:Up to day 35
Safety Issue:
Description:The binomial proportion of PPV and the corresponding Exact confidence intervals will be calculated. In addition, the calculated PPV will be tested to see if it's significantly larger than 0.79 (PPV of day-14 BMBX in CR prediction).
Measure:Sensitivity of FLT PET/CT for complete remission detection
Time Frame:Up to day 35
Safety Issue:
Description:The binomial proportions and the corresponding Exact confidence intervals will be calculated for sensitivity estimation.
Measure:Specificity of FLT PET/CT for complete remission detection
Time Frame:Up to day 35
Safety Issue:
Description:The binomial proportions and the corresponding Exact confidence intervals will be calculated for specificity estimation.
Measure:Pre-treatment FLT PET/CT activity as a predictor of complete remission
Time Frame:Baseline
Safety Issue:
Description:The receiver operating characteristic (ROC) approach will be used to test the continue measurement of this variable in predicting CR.
Measure:Change between pre-treatment and post-treatment FLT PET/CT activity as a predictor of complete remission
Time Frame:Baseline to up to day 35
Safety Issue:
Description:The ROC approach will be used to test the continue measurement of this variable in predicting CR.
Measure:Biologic correlates of AML (MRD assessment)
Time Frame:At day 14
Safety Issue:
Description:Correlation of FLT PET/CT imaging parameters (SUVmax, SUVmean, SUVhetero) with biologic correlates will be studied and regression analysis will be used to assess this aim.

Details

Phase:Phase 2
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:National Cancer Institute (NCI)

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