Physical Conditioning and Decitabine for Newly Diagnosed AML Patients Age ≥ 60
Public ClinicalTrials.gov record NCT02234037. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT02234037
- Recruitment status
- Terminated
- Study type
- Interventional
- Phase
- Phase 1
- Enrollment
- 3 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 60 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Oct 31, 2013
- Primary completion
- Jan 31, 2016
- Completion
- Apr 30, 2016
- Last update posted
- Jan 29, 2017
2013 – 2016
United States locations
- U.S. sites
- 1
- U.S. states
- 1
- U.S. cities
- 1
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Winship Cancer Institute of Emory University | Atlanta | Georgia | 30322 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT02234037, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jan 29, 2017 · Synced Sep 2, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT02234037 live on ClinicalTrials.gov.