LeukemiaPhase 1NCT02234037
Physical Conditioning and Decitabine for Newly Diagnosed AML Patients Age ≥ 60
A Phase 1 study testing Decitabine and Exercise in people with Leukemia, run by Emory University at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Leukemia
- What is being tested?
- Decitabine and Exercise
- Type of treatment
- Injection or infusion, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2013to May 2016
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of AML including de novo, secondary, or with an antecedent hematologic disorder (AHD) according to the World Health Organization (WHO) criteria
- Age ≥ 60 years
- Patient not eligible for (immediate) standard induction chemotherapy based on the opinion of the treating physician and the frailty score
- Provide signed written informed consent
- Be able to comply with study procedures and follow-up examinations
- Adequate heart function with echocardiogram demonstrating ejection fraction ≥ 45% with no evidence of systolic dysfunction
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- Adequate renal and hepatic function:
- Total bilirubin ≤ 2x institutional Upper Limit of Normal (ULN); and
- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3x ULN; and
- Serum creatinine ≤ 2 times the upper limit of normal
- ECOG performance < 4
- Patients with a history of carcinoma in remission (on no therapy or on hormonal therapy for the adjuvant treatment of breast carcinoma or prostate carcinoma) are included in the study.
Who cannot join
- Diagnosis of acute promyelocytic leukemia (APL, French-American-British [FAB] classification M3 or WHO classification of APL with t(15;17)(q22;q12)), (PML/retinoic acid receptor alpha [RARa] and variants)
- Prior treatment with decitabine for myelodysplastic syndrome (MDS) or AML
- Relapsed or refractory AML
- Rapidly doubling white cell count uncontrolled with hydroxyurea
- Coronary artery disease with angina limiting exercise capability
- Joint disease limiting exercise capability
Show all 12Show fewer
- Investigational agent received within 30 days prior to the first dose of study drug. If received any investigational agent prior to this time point, drug-related toxicities must have recovered to Grade 2 or less prior to first dose of study drug
- Psychiatric disorders that would interfere with consent, study participation, or follow-up
- Systemic fungal, bacterial, viral, or other infection not controlled (defined as exhibiting ongoing signs/symptoms related to the infection and without improvement, despite appropriate antibiotics or other treatment)
- Any other severe concurrent disease, or serious organ dysfunction or disease involving the heart, kidney, liver, or other organ system that may place the patient at undue risk to undergo the proposed therapy
- No social support or inability to attend study-related visits
- Carcinoma requiring systemic chemotherapy or radiation therapy
Trial locations and contacts
1 site in 1 country.
United States1 site
Winship Cancer Institute of Emory University
Atlanta, Georgia, 30322
About this study
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
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.
Read more
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.
Read the detailed description
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.
- Conditions
- Leukemia
- Being tested
- Decitabine, Exercise
- Keywords
- AML
- Medical subject headings
- Leukemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DecitabineDrug
Also called Dacogen
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.
ExerciseBehavioural
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).
| Study group | Role | What they receive |
|---|---|---|
| Decitabine and Exercise | Experimental | 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. Receives: Drug: Decitabine; Behavioral: Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Performance status
ECOG performance status is assessed before, at 4 weeks and 8 weeks from start of the intervention.
Measured: Up to 8 weeks
Proportion of patients with 25% improvement in fitness scores
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.
Measured: Up to 8 weeks
Function
Function will be measured using the 6-meter walk test, timed Up and Go test, grip strength and lower limb strength.
Measured: 8 weeks
Activity
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.
Measured: 8 weeks
Secondary outcomes (3)
Number of patients with adverse events related to the intervention.
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.
Measured: 8 weeks
Response to treatment
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.
Measured: 18 months
Quality of life and depression scores among study subjects before and after the 8-week exercise program
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.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2014 (estimated)
- Study startNov 2013
- Primary completionFeb 2016
- Study completionMay 2016
Why it stopped: Slow accrual
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LeukemiaStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Martha Arellano, Emory University
- Investigators
- Martha L Arellano, MD, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02234037
- Sponsor's protocol ID
- IRB00064866
- Other IDs
- WINSHIP2381-12
- Status last verified
- Jan 2017
- First submitted
- 27 Feb 2014
- Last updated
- 30 Jan 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02234037
- Acronym / sponsor ID
- IRB00064866
- Conditions
- Leukemia
- Keywords
- AML
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Slow accrual
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Study start
- Nov 2013
- Primary completion
- Feb 2016 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 9 Sep 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Decitabine and Exercise | Experimental | Drug: Decitabine, Behavioral: Exercise8-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. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Diagnosis of AML including de novo, secondary, or with an antecedent hematologic disorder (AHD) according to the World Health Organization (WHO) criteria
- Age ≥ 60 years
- Patient not eligible for (immediate) standard induction chemotherapy based on the opinion of the treating physician and the frailty score
- Provide signed written informed consent
- Be able to comply with study procedures and follow-up examinations
Key exclusion criteria (12 listed)
- Diagnosis of acute promyelocytic leukemia (APL, French-American-British [FAB] classification M3 or WHO classification of APL with t(15;17)(q22;q12)), (PML/retinoic acid receptor alpha [RARa] and variants)
- Prior treatment with decitabine for myelodysplastic syndrome (MDS) or AML
- Relapsed or refractory AML
- Rapidly doubling white cell count uncontrolled with hydroxyurea
- Coronary artery disease with angina limiting exercise capability
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DecitabineAlso: DacogenDecitabine 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. | Drug | Decitabine and Exercise |
| ExerciseEach 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). | Behavioural | Decitabine and Exercise |
Primary outcome
Performance status
Time frame: Up to 8 weeks
ECOG performance status is assessed before, at 4 weeks and 8 weeks from start of the intervention.
Proportion of patients with 25% improvement in fitness scores
Time frame: Up to 8 weeks
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.
Function
Time frame: 8 weeks
Function will be measured using the 6-meter walk test, timed Up and Go test, grip strength and lower limb strength.
Activity
Time frame: 8 weeks
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.
3 secondary outcomes
Number of patients with adverse events related to the intervention.
Time frame: 8 weeks
Response to treatment
Time frame: 18 months
Quality of life and depression scores among study subjects before and after the 8-week exercise program
Time frame: 8 weeks
Results and safety
The study was stopped early (reason given: Slow accrual). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Martha L Arellano, MD principal investigator
Emory University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Decitabine and Exercise in people with Leukemia, run by Emory University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 30 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Slow accrual). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Performance status (time frame: Up to 8 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jan 2017.