<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02234037</url>
  </required_header>
  <id_info>
    <org_study_id>IRB00064866</org_study_id>
    <secondary_id>WINSHIP2381-12</secondary_id>
    <nct_id>NCT02234037</nct_id>
  </id_info>
  <brief_title>Physical Conditioning and Decitabine for Newly Diagnosed AML Patients Age ≥ 60</brief_title>
  <official_title>A Pilot Study of Physical Conditioning and Decitabine for Newly Diagnosed AML Patients Age ≥ 60 Who Are Not Candidates for Standard Induction Chemotherapy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Emory University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Emory University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      STUDY BACKGROUND AND PURPOSE:&#xD;
&#xD;
      Acute myelogenous leukemia (AML) is a common type of blood cancer in adults, and is more&#xD;
      common with increasing age. AML is harder to treat in older patients, with typically poor&#xD;
      responses to standard chemotherapy.&#xD;
&#xD;
      Patients with AML are typically given intensive induction chemotherapy, but many older&#xD;
      patients cannot tolerate the side effects of this therapy. Decitabine has been shown to be&#xD;
      active and better tolerated in frail patients with AML; however, most patients still relapse.&#xD;
&#xD;
      Recent studies suggest that improving the performance status and fitness of older AML&#xD;
      patients prior to induction chemotherapy may help to lessen side effects.&#xD;
&#xD;
      This study will test the combination of decitabine treatment with physical exercise in&#xD;
      elderly patients with AML who are not candidates for standard induction chemotherapy.&#xD;
&#xD;
      STUDY DESCRIPTION:&#xD;
&#xD;
      This is a pilot study to test the combination of decitabine treatment with an 8-week physical&#xD;
      exercise program in AML patients ≥ 60 years of age who are not candidates for standard&#xD;
      induction chemotherapy. Patients who are eligible to take part must give their written&#xD;
      agreement before they can be enrolled.&#xD;
&#xD;
      This study will enroll 20 patients who are not candidates for standard induction&#xD;
      chemotherapy. Patients will begin an 8-week program of physical exercise, including 2-3&#xD;
      sessions per week supervised by a physical therapist. During this 8-week period, patients&#xD;
      will be given 2 cycles of decitabine therapy (daily infusion for 5 consecutive days of a&#xD;
      28-day cycle).&#xD;
&#xD;
      Patients will be followed to assess the safety and tolerability of the program. Patients will&#xD;
      also give blood samples that will be used to assess their response to treatment. Patients&#xD;
      will be evaluated for their physical fitness before and after the 8-week exercise program and&#xD;
      will complete questionnaires to assess their quality of life before and after the program.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Primary Objectives:&#xD;
&#xD;
      • Number of patients age 60 and older with newly diagnosed AML and who are not candidates for&#xD;
      standard induction chemotherapy who complete an 8-week program of physical conditioning and&#xD;
      decitabine treatment. The goal is set at 30% of 20 enrolled patients completing the 8 weeks&#xD;
      of decitabine and physical conditioning program.&#xD;
&#xD;
      Secondary Objectives:&#xD;
&#xD;
        -  Number of patients with adverse events as a measure of safety and tolerability of the&#xD;
           physical conditioning program during decitabine therapy.&#xD;
&#xD;
        -  Number of patients with overall response (complete response, disease-free survival&#xD;
           [DFS], and overall survival [OS]) of the rehabilitated patients after conclusion of the&#xD;
           8-week program.&#xD;
&#xD;
        -  Changes in quality of life among study subjects before and after the 8-week exercise&#xD;
           program.&#xD;
&#xD;
        -  Changes in cytokine profiles drawn at baseline, 4 weeks and 8 weeks.&#xD;
&#xD;
      Treatment Plan:&#xD;
&#xD;
        -  Twenty subjects, age 60 and older with newly diagnosed AML who are deemed by their&#xD;
           referring physicians not to be candidates for standard induction chemotherapy will be&#xD;
           recruited from the inpatient and outpatient services at Emory University Hospital and&#xD;
           the Winship Cancer Institute of Emory University.&#xD;
&#xD;
        -  After signing the informed consent and Health Insurance Portability and Accountability&#xD;
           Act (HIPAA) forms, a screening evaluation will be performed. Subjects who are eligible&#xD;
           will meet with the physical therapist and will enroll on an 8-week program of physical&#xD;
           conditioning.&#xD;
&#xD;
        -  Each patient will participate in 2-3 exercise sessions per week supervised by a physical&#xD;
           therapist and a home exercise program. Evaluations of physical fitness will be performed&#xD;
           before and after the 8-week exercise program. Each exercise session will be customized&#xD;
           based on each patient's baseline fitness level. Subjects' heart rate, blood pressure,&#xD;
           and rate of perceived exertion score will be monitored during the exercise treatment&#xD;
           session.&#xD;
&#xD;
        -  Patients' fitness at the conclusion of the physical therapy regimen will be assessed by&#xD;
           checking for improvement in Eastern Cooperative Oncology Group (ECOG) performance status&#xD;
           by at least 1 point from baseline and 25% improvement in the Special Forces (SF)-36&#xD;
           fitness scoring system.&#xD;
&#xD;
        -  Decitabine will be infused according to standard of care practice with daily infusions&#xD;
           for 5 consecutive days of a 28-day cycle for 2 cycles (1 cycle = 28 days) during the 8&#xD;
           week physical-conditioning period.&#xD;
&#xD;
        -  Patients will be assessed by the hematology provider on a weekly basis, and adverse&#xD;
           events/toxicities will be recorded on an ongoing basis.&#xD;
&#xD;
        -  Bone marrow biopsies will be obtained at baseline, at 8 weeks, and as clinically&#xD;
           indicated to assess for response. A sample of marrow will be collected for correlative&#xD;
           assays coincident with the standard of care collections.&#xD;
&#xD;
        -  Peripheral blood (20 mL) will be collected for correlative studies at baseline, 4 weeks&#xD;
           and 8 weeks.&#xD;
&#xD;
      Assessment of Disease Response:&#xD;
&#xD;
        -  Complete blood counts (CBC) with differential will be obtained weekly and bone marrow&#xD;
           biopsy and aspirates will be obtained as clinically indicated to assess response to&#xD;
           treatment.&#xD;
&#xD;
        -  Active participation in the study will end 1 month after completion of the 8-week&#xD;
           exercise/decitabine program. Thereafter, long term follow-up for survival will be&#xD;
           performed by record review or telephone interview for patients who no longer follow-up&#xD;
           at Winship Cancer Institute of Emory University.&#xD;
&#xD;
      Monitoring:&#xD;
&#xD;
      The study will be monitored by the Data Safety Monitoring Committee at the study institution.&#xD;
&#xD;
      Statistical Methods:&#xD;
&#xD;
        -  Feasibility: Based on data showing that 50% of older fit AML patients tolerated a 4-week&#xD;
           exercise regimen, feasibility is defined as:&#xD;
&#xD;
             -  Completion of the 8-week physical conditioning regimen/decitabine program in at&#xD;
                least 30% of the study subjects.&#xD;
&#xD;
             -  The proportion of patients with full treatment delivery will be estimated with an&#xD;
                exact 90% confidence interval.&#xD;
&#xD;
        -  Assessment for fitness of the study population will be undertaken at 4 weeks from&#xD;
           enrollment and conclusion of the 8-week physical therapy regimen.&#xD;
&#xD;
        -  Kaplan-Meier curves will be used to estimate the distribution of time to relapse,&#xD;
           disease-free survival, and overall survival.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Slow accrual&#xD;
  </why_stopped>
  <start_date>November 2013</start_date>
  <completion_date type="Actual">May 2016</completion_date>
  <primary_completion_date type="Actual">February 2016</primary_completion_date>
  <phase>Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Performance status</measure>
    <time_frame>Up to 8 weeks</time_frame>
    <description>ECOG performance status is assessed before, at 4 weeks and 8 weeks from start of the intervention.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Proportion of patients with 25% improvement in fitness scores</measure>
    <time_frame>Up to 8 weeks</time_frame>
    <description>Patients will be asked to answer questions on the 36-item (SF-36) fitness scoring system and the FACIT-Leu fatigue scale at baseline, 4 weeks and 8 weeks of the study.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Function</measure>
    <time_frame>8 weeks</time_frame>
    <description>Function will be measured using the 6-meter walk test, timed Up and Go test, grip strength and lower limb strength.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Activity</measure>
    <time_frame>8 weeks</time_frame>
    <description>Activity will be based on daily stepping activity (measured using step activity monitors), endurance (distance ambulated in 3-minutes), and duration of aerobic exercise (treadmill walking or cycling) at 50% heart rate and/or Borg score &gt; 5.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of patients with adverse events related to the intervention.</measure>
    <time_frame>8 weeks</time_frame>
    <description>Toxicities will be monitored on an ongoing basis, based on review of symptoms, physical examination, and laboratory tests weekly. Adverse events (AEs) will be monitored and recorded on case report forms on an ongoing basis and will be graded using the NCI Common Toxicity Criteria (CTC) AE V. 4.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Response to treatment</measure>
    <time_frame>18 months</time_frame>
    <description>This outcome will evaluate the response to treatment (complete response, disease-free survival [DFS], and overall survival [OS]) of the rehabilitated patients after conclusion of the 8-week program. Disease status will be assessed by a peripheral blood and bone marrow aspirate and biopsy as clinically indicated.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of life and depression scores among study subjects before and after the 8-week exercise program</measure>
    <time_frame>8 weeks</time_frame>
    <description>This outcome will evaluate changes in quality of life among study subjects before and after the 8-week exercise program, from quality of life questionnaires and depression scores.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">3</enrollment>
  <condition>Leukemia</condition>
  <arm_group>
    <arm_group_label>Decitabine and Exercise</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>8-week program of physical conditioning and decitabine treatment in newly diagnosed AML patients ≥ 60 years of age who are not candidates for standard induction chemotherapy.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Decitabine</intervention_name>
    <description>Decitabine will be administered intravenously at dose of 20mg/m² on 5 consecutive days every 28 days (1 cycle = 28 days) for a total of 2 cycles according to standard practice. Cycle 2 will proceed on time despite cytopenias, given that patients are not expected to be in remission after only 1 cycle of decitabine.</description>
    <arm_group_label>Decitabine and Exercise</arm_group_label>
    <other_name>Dacogen</other_name>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Exercise</intervention_name>
    <description>Each patient will participate in 2-3 exercise sessions per week supervised by a physical therapist. Each exercise session will comprise &gt; 10 minutes of muscle strengthening, &gt; 10 minutes of aerobic exercise (treadmill walking or cycling), &gt; 10 minutes of stretching/range of motion exercises, and up to 10 minutes of individualized functional exercise (determined based on patient's reported deficits/targets in activities of daily living).</description>
    <arm_group_label>Decitabine and Exercise</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Diagnosis of AML including de novo, secondary, or with an antecedent hematologic&#xD;
             disorder (AHD) according to the World Health Organization (WHO) criteria&#xD;
&#xD;
          -  Age ≥ 60 years&#xD;
&#xD;
          -  Patient not eligible for (immediate) standard induction chemotherapy based on the&#xD;
             opinion of the treating physician and the frailty score&#xD;
&#xD;
          -  Provide signed written informed consent&#xD;
&#xD;
          -  Be able to comply with study procedures and follow-up examinations&#xD;
&#xD;
          -  Adequate heart function with echocardiogram demonstrating ejection fraction ≥ 45% with&#xD;
             no evidence of systolic dysfunction&#xD;
&#xD;
          -  Adequate renal and hepatic function:&#xD;
&#xD;
               -  Total bilirubin ≤ 2x institutional Upper Limit of Normal (ULN); and&#xD;
&#xD;
               -  Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3x ULN; and&#xD;
&#xD;
               -  Serum creatinine ≤ 2 times the upper limit of normal&#xD;
&#xD;
          -  ECOG performance &lt; 4&#xD;
&#xD;
          -  Patients with a history of carcinoma in remission (on no therapy or on hormonal&#xD;
             therapy for the adjuvant treatment of breast carcinoma or prostate carcinoma) are&#xD;
             included in the study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Diagnosis of acute promyelocytic leukemia (APL, French-American-British [FAB]&#xD;
             classification M3 or WHO classification of APL with t(15;17)(q22;q12)), (PML/retinoic&#xD;
             acid receptor alpha [RARa] and variants)&#xD;
&#xD;
          -  Prior treatment with decitabine for myelodysplastic syndrome (MDS) or AML&#xD;
&#xD;
          -  Relapsed or refractory AML&#xD;
&#xD;
          -  Rapidly doubling white cell count uncontrolled with hydroxyurea&#xD;
&#xD;
          -  Coronary artery disease with angina limiting exercise capability&#xD;
&#xD;
          -  Joint disease limiting exercise capability&#xD;
&#xD;
          -  Investigational agent received within 30 days prior to the first dose of study drug.&#xD;
             If received any investigational agent prior to this time point, drug-related&#xD;
             toxicities must have recovered to Grade 2 or less prior to first dose of study drug&#xD;
&#xD;
          -  Psychiatric disorders that would interfere with consent, study participation, or&#xD;
             follow-up&#xD;
&#xD;
          -  Systemic fungal, bacterial, viral, or other infection not controlled (defined as&#xD;
             exhibiting ongoing signs/symptoms related to the infection and without improvement,&#xD;
             despite appropriate antibiotics or other treatment)&#xD;
&#xD;
          -  Any other severe concurrent disease, or serious organ dysfunction or disease involving&#xD;
             the heart, kidney, liver, or other organ system that may place the patient at undue&#xD;
             risk to undergo the proposed therapy&#xD;
&#xD;
          -  No social support or inability to attend study-related visits&#xD;
&#xD;
          -  Carcinoma requiring systemic chemotherapy or radiation therapy&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>60 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Martha L Arellano, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Emory University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Winship Cancer Institute of Emory University</name>
      <address>
        <city>Atlanta</city>
        <state>Georgia</state>
        <zip>30322</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2017</verification_date>
  <study_first_submitted>February 27, 2014</study_first_submitted>
  <study_first_submitted_qc>September 4, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 9, 2014</study_first_posted>
  <last_update_submitted>January 26, 2017</last_update_submitted>
  <last_update_submitted_qc>January 26, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 30, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Emory University</investigator_affiliation>
    <investigator_full_name>Martha Arellano</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>AML</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Decitabine</mesh_term>
  </intervention_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02234037
org study id: IRB00064866
secondary id: WINSHIP2381-12
nct id: NCT02234037
lead sponsor: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
STUDY BACKGROUND AND PURPOSE:

      Acute myelogenous leukemia (AML) is a common type of blood cancer in adults, and is more
      common with increasing age. AML is harder to treat in older patients, with typically poor
      responses to standard chemotherapy.

      Patients with AML are typically given intensive induction chemotherapy, but many older
      patients cannot tolerate the side effects of this therapy. Decitabine has been shown to be
      active and better tolerated in frail patients with AML; however, most patients still relapse.

      Recent studies suggest that improving the performance status and fitness of older AML
      patients prior to induction chemotherapy may help to lessen side effects.

      This study will test the combination of decitabine treatment with physical exercise in
      elderly patients with AML who are not candidates for standard induction chemotherapy.

      STUDY DESCRIPTION:

      This is a pilot study to test the combination of decitabine treatment with an 8-week physical
      exercise program in AML patients ≥ 60 years of age who are not candidates for standard
      induction chemotherapy. Patients who are eligible to take part must give their written
      agreement before they can be enrolled.

      This study will enroll 20 patients who are not candidates for standard induction
      chemotherapy. Patients will begin an 8-week program of physical exercise, including 2-3
      sessions per week supervised by a physical therapist. During this 8-week period, patients
      will be given 2 cycles of decitabine therapy (daily infusion for 5 consecutive days of a
      28-day cycle).

      Patients will be followed to assess the safety and tolerability of the program. Patients will
      also give blood samples that will be used to assess their response to treatment. Patients
      will be evaluated for their physical fitness before and after the 8-week exercise program and
      will complete questionnaires to assess their quality of life before and after the program.
Primary Objectives:

      • Number of patients age 60 and older with newly diagnosed AML and who are not candidates for
      standard induction chemotherapy who complete an 8-week program of physical conditioning and
      decitabine treatment. The goal is set at 30% of 20 enrolled patients completing the 8 weeks
      of decitabine and physical conditioning program.

      Secondary Objectives:

        -  Number of patients with adverse events as a measure of safety and tolerability of the
           physical conditioning program during decitabine therapy.

        -  Number of patients with overall response (complete response, disease-free survival
           [DFS], and overall survival [OS]) of the rehabilitated patients after conclusion of the
           8-week program.

        -  Changes in quality of life among study subjects before and after the 8-week exercise
           program.

        -  Changes in cytokine profiles drawn at baseline, 4 weeks and 8 weeks.

      Treatment Plan:

        -  Twenty subjects, age 60 and older with newly diagnosed AML who are deemed by their
           referring physicians not to be candidates for standard induction chemotherapy will be
           recruited from the inpatient and outpatient services at Emory University Hospital and
           the Winship Cancer Institute of Emory University.

        -  After signing the informed consent and Health Insurance Portability and Accountability
           Act (HIPAA) forms, a screening evaluation will be performed. Subjects who are eligible
           will meet with the physical therapist and will enroll on an 8-week program of physical
           conditioning.

        -  Each patient will participate in 2-3 exercise sessions per week supervised by a physical
           therapist and a home exercise program. Evaluations of physical fitness will be performed
           before and after the 8-week exercise program. Each exercise session will be customized
           based on each patient's baseline fitness level. Subjects' heart rate, blood pressure,
           and rate of perceived exertion score will be monitored during the exercise treatment
           session.

        -  Patients' fitness at the conclusion of the physical therapy regimen will be assessed by
           checking for improvement in Eastern Cooperative Oncology Group (ECOG) performance status
           by at least 1 point from baseline and 25% improvement in the Special Forces (SF)-36
           fitness scoring system.

        -  Decitabine will be infused according to standard of care practice with daily infusions
           for 5 consecutive days of a 28-day cycle for 2 cycles (1 cycle = 28 days) during the 8
           week physical-conditioning period.

        -  Patients will be assessed by the hematology provider on a weekly basis, and adverse
           events/toxicities will be recorded on an ongoing basis.

        -  Bone marrow biopsies will be obtained at baseline, at 8 weeks, and as clinically
           indicated to assess for response. A sample of marrow will be collected for correlative
           assays coincident with the standard of care collections.

        -  Peripheral blood (20 mL) will be collected for correlative studies at baseline, 4 weeks
           and 8 weeks.

      Assessment of Disease Response:

        -  Complete blood counts (CBC) with differential will be obtained weekly and bone marrow
           biopsy and aspirates will be obtained as clinically indicated to assess response to
           treatment.

        -  Active participation in the study will end 1 month after completion of the 8-week
           exercise/decitabine program. Thereafter, long term follow-up for survival will be
           performed by record review or telephone interview for patients who no longer follow-up
           at Winship Cancer Institute of Emory University.

      Monitoring:

      The study will be monitored by the Data Safety Monitoring Committee at the study institution.

      Statistical Methods:

        -  Feasibility: Based on data showing that 50% of older fit AML patients tolerated a 4-week
           exercise regimen, feasibility is defined as:

             -  Completion of the 8-week physical conditioning regimen/decitabine program in at
                least 30% of the study subjects.

             -  The proportion of patients with full treatment delivery will be estimated with an
                exact 90% confidence interval.

        -  Assessment for fitness of the study population will be undertaken at 4 weeks from
           enrollment and conclusion of the 8-week physical therapy regimen.

        -  Kaplan-Meier curves will be used to estimate the distribution of time to relapse,
           disease-free survival, and overall survival.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Performance status
time frame: Up to 8 weeks
description: ECOG performance status is assessed before, at 4 weeks and 8 weeks from start of the intervention.
measure: Proportion of patients with 25% improvement in fitness scores
time frame: Up to 8 weeks
description: Patients will be asked to answer questions on the 36-item (SF-36) fitness scoring system and the FACIT-Leu fatigue scale at baseline, 4 weeks and 8 weeks of the study.
measure: Function
time frame: 8 weeks
description: Function will be measured using the 6-meter walk test, timed Up and Go test, grip strength and lower limb strength.
measure: Activity
time frame: 8 weeks
description: Activity will be based on daily stepping activity (measured using step activity monitors), endurance (distance ambulated in 3-minutes), and duration of aerobic exercise (treadmill walking or cycling) at 50% heart rate and/or Borg score > 5.
measure: Number of patients with adverse events related to the intervention.
time frame: 8 weeks
description: Toxicities will be monitored on an ongoing basis, based on review of symptoms, physical examination, and laboratory tests weekly. Adverse events (AEs) will be monitored and recorded on case report forms on an ongoing basis and will be graded using the NCI Common Toxicity Criteria (CTC) AE V. 4.
measure: Response to treatment
time frame: 18 months
description: This outcome will evaluate the response to treatment (complete response, disease-free survival [DFS], and overall survival [OS]) of the rehabilitated patients after conclusion of the 8-week program. Disease status will be assessed by a peripheral blood and bone marrow aspirate and biopsy as clinically indicated.
measure: Quality of life and depression scores among study subjects before and after the 8-week exercise program
time frame: 8 weeks
description: This outcome will evaluate changes in quality of life among study subjects before and after the 8-week exercise program, from quality of life questionnaires and depression scores.
arm group label: Decitabine and Exercise
arm group type: Experimental
description: 8-week program of physical conditioning and decitabine treatment in newly diagnosed AML patients ≥ 60 years of age who are not candidates for standard induction chemotherapy.
intervention type: Drug
intervention name: Decitabine
description: Decitabine will be administered intravenously at dose of 20mg/m² on 5 consecutive days every 28 days (1 cycle = 28 days) for a total of 2 cycles according to standard practice. Cycle 2 will proceed on time despite cytopenias, given that patients are not expected to be in remission after only 1 cycle of decitabine.
arm group label: Decitabine and Exercise
other name: Dacogen
intervention type: Behavioral
intervention name: Exercise
description: Each patient will participate in 2-3 exercise sessions per week supervised by a physical therapist. Each exercise session will comprise > 10 minutes of muscle strengthening, > 10 minutes of aerobic exercise (treadmill walking or cycling), > 10 minutes of stretching/range of motion exercises, and up to 10 minutes of individualized functional exercise (determined based on patient's reported deficits/targets in activities of daily living).
arm group label: Decitabine and Exercise
criteria: 
gender: All
minimum age: 60 Years
maximum age: N/A
healthy volunteers: No
last name: Martha L Arellano, MD
role: Principal Investigator
affiliation: Emory University
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Emory University
investigator full name: Martha Arellano
investigator title: Principal Investigator
mesh term: Decitabine