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NCT02234037 · ClinicalTrials.gov registry record · Phase 1
Physical Conditioning and Decitabine for Newly Diagnosed AML Patients Age ≥ 60
A Phase 1 study, sponsored by Emory University.
- Terminated
- Registry status
- Phase 1
- Development phase
- 3
- Enrollment target
NCT02234037 is a Phase 1 study that was terminated before completion, run by Emory University. The registered enrollment target is 3 participants.
The verdict
NCT02234037, a Phase 1 study, was terminated before completion, sponsored by Emory University.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 3 participants
- Enrollment target
Study 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. 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.
Interventions
- DRUG Decitabine
- BEHAVIORAL Exercise
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 3 participants |
| Start Date | 2013-11 |
| Est. Completion | 2016-05 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02234037
The ClinicalTrials.gov registry entry for NCT02234037 describes a study currently listed as terminated, categorized as Phase 1. The registered enrollment target is 3 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Emory University, which has 1,208 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Decitabine is the first listed.
NCT02234037 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02234037 about?
NCT02234037 is a clinical study titled "Physical Conditioning and Decitabine for Newly Diagnosed AML Patients Age ≥ 60". 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 induc...
What is the current status of trial NCT02234037?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 3 participants. The study started on 2013-11. Estimated completion is 2016-05.
What interventions are being tested in trial NCT02234037?
The interventions under investigation include: Decitabine (DRUG), Exercise (BEHAVIORAL).
Who is sponsoring clinical trial NCT02234037?
This trial is sponsored by Emory University, which has 1,208 total clinical trials registered on ClinicalTrials.gov.
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