Acute Myeloid LeukemiaNCT02598752
Feasibility and Safety of Functional Performance Testing in Patients Undergoing Hematopoietic Cell Transplantation
An observational study of Acute Myeloid Leukemia and Myelodysplastic Syndrome, run by Memorial Sloan Kettering Cancer Center at 1 site in United States.
Trial summary
The purpose of this study is to see if exercise fitness testing is feasible and safe in persons over 21 years of age who have been diagnosed with a hematological malignancy and are scheduled to undergo a hematopoietic stem cell transplant (HCT). Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Acute Myeloid Leukemia, Myelodysplastic Syndrome, Hematological Malignancy
- What is being tested?
- Symptom-limited cardiopulmonary exercise test (CPET), Resting assessment of cardiac function by echocardiography and Post-exercise assessment of cardiac function by echocardiography
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 11 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2015to 10 Apr 2020
- Phase
- Observational
- 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Potentially eligible will be identified through and recruited from the Adult Bone Marrow Transplantation clinics at MSK.
Who may be able to join
- Patients with MSK histologically confirmed hematologic malignancy
- Scheduled for autologous or allogenic HCT at MSKCC
- ≥21 years old
- ECOG performance status of 0 or 1
- Completion of baseline CPET
- Willing to comply with protocol related procedures
Who cannot join
- Any of the following absolute contraindications to cardiopulmonary exercise testing
- Acute myocardial Infarction (within 3-5 days of any planned study procedures)
- Unstable angina
- Uncontrolled arrhythmia causing symptoms or hemodynamic compromise
- Recurrent syncope
- Active endocarditis
Show all 20Show fewer
- Acute myocarditis or pericarditis
- Symptomatic severe aortic stenosis
- Uncontrolled heart failure
- Acute pulmonary embolus or pulmonary infarction within 3 months of any planned study procedures
- Thrombosis of lower extremities
- Suspected dissecting aneurysm
- Uncontrolled asthma
- Pulmonary edema
- Respiratory failure
- Acute non-cardiopulmonary disorders that may affect exercise performance or be aggravated by exercise (i.e., infection, renal failure, thyrotoxicosis)
- Presence of any other concurrent, actively treated malignancy;
- History of any other malignancy treated within the past 3 years (other than non-melanoma skin cancer);
- Room air desaturation at rest ≤85%
- Mental impairment leading to inability to cooperate
Trial locations and contacts
1 site in 1 country.
United States1 site
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
About this study
The purpose of this study is to see if exercise fitness testing is feasible and safe in persons over 21 years of age who have been diagnosed with a hematological malignancy and are scheduled to undergo a hematopoietic stem cell transplant (HCT). Assessments in this study will look at the capacity of the body before transplantation to see if these measures can help predict how patients do after transplant.
- Conditions
- Acute Myeloid Leukemia, Myelodysplastic Syndrome, Hematological Malignancy, Leukemia, Lymphoma, Myeloma
- Being tested
- Symptom-limited cardiopulmonary exercise test (CPET), Resting assessment of cardiac function by echocardiography, Post-exercise assessment of cardiac function by echocardiography, Pulmonary function, Patient-reported outcomes questionnaire
- Keywords
- functional performance testing, exercise fitness testing, 15-274
- Medical subject headings
- Leukemia, Myeloid, Acute, Myelodysplastic Syndromes, Hematologic Neoplasms, Leukemia, Lymphoma, Neoplasms, Plasma Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Symptom-limited cardiopulmonary exercise test (CPET)Other
Resting assessment of cardiac function by echocardiographyOther
Post-exercise assessment of cardiac function by echocardiographyOther
Pulmonary functionOther
Patient-reported outcomes questionnaireBehavioural
| Study group | Role | What they receive |
|---|---|---|
| functional performance testing | This observational study will evaluate the feasibility and safety of functional performance testing in patients undergoing HCT. In addition to standard of care procedures, participants will undergo a CPET with a rest and stress echo, pulmonary function, and patient reported outcome questionnaires within 30 days of HCT. Receives: Other: Symptom-limited cardiopulmonary exercise test (CPET); Other: Resting assessment of cardiac function by echocardiography; Other: Post-exercise assessment of cardiac function by echocardiography; Other: Pulmonary function; Behavioral: Patient-reported outcomes questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
VO2peak
is a measure determined by the CPET
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2015 (estimated)
- Study startNov 2015
- Primary completion10 Apr 2020
- Study completion10 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Myeloid LeukemiaStudies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering Cancer CenterThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jessica Scott, PhD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02598752
- Sponsor's protocol ID
- 15-274
- Status last verified
- Apr 2020
- First submitted
- 4 Nov 2015
- Last updated
- 16 Apr 2020
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility and Safety of Functional Performance Testing in Patients Undergoing Hematopoietic Cell Transplantation
- ClinicalTrials.gov ID
- NCT02598752
- Acronym / sponsor ID
- 15-274
- Conditions
- Acute Myeloid Leukemia, Myelodysplastic Syndrome, Hematological Malignancy, Leukemia, Lymphoma, Myeloma
- Keywords
- functional performance testing, exercise fitness testing, 15-274
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Study start
- Nov 2015 (actual)
- Primary completion
- 10 Apr 2020 (actual)
- Study completion
- 10 Apr 2020 (actual)
- First posted
- 6 Nov 2015 (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.
The purpose of this study is to see if exercise fitness testing is feasible and safe in persons over 21 years of age who have been diagnosed with a hematological malignancy and are scheduled to undergo a hematopoietic stem cell transplant (HCT). Assessments in this study will look at the capacity of the body before transplantation to see if these measures can help predict how patients do after transplant.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| functional performance testing | – | Other: Symptom-limited cardiopulmonary exercise test (CPET), Other: Resting assessment of cardiac function by echocardiography, Other: Post-exercise assessment of cardiac function by echocardiography, Other: Pulmonary function, Behavioral: Patient-reported outcomes questionnaireThis observational study will evaluate the feasibility and safety of functional performance testing in patients undergoing HCT. In addition to standard of care procedures, participants will undergo a CPET with a rest and stress echo, pulmonary function, and patient reported outcome questionnaires within 30 days of HCT. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Potentially eligible will be identified through and recruited from the Adult Bone Marrow Transplantation clinics at MSK.
Key inclusion criteria (6 listed)
- Patients with MSK histologically confirmed hematologic malignancy
- Scheduled for autologous or allogenic HCT at MSKCC
- ≥21 years old
- ECOG performance status of 0 or 1
- Completion of baseline CPET
Key exclusion criteria (20 listed)
- Any of the following absolute contraindications to cardiopulmonary exercise testing
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 |
|---|---|---|
| Symptom-limited cardiopulmonary exercise test (CPET) | Other | functional performance testing |
| Resting assessment of cardiac function by echocardiography | Other | functional performance testing |
| Post-exercise assessment of cardiac function by echocardiography | Other | functional performance testing |
| Pulmonary function | Other | functional performance testing |
| Patient-reported outcomes questionnaire | Behavioural | functional performance testing |
Primary outcome
VO2peak
Time frame: 1 year
is a measure determined by the CPET
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2020.
- Memorial Sloan Kettering Cancer CenterLink provided by the sponsor.
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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.
Jessica Scott, PhD principal investigator
Memorial Sloan Kettering Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Myeloid Leukemia and Myelodysplastic Syndrome, run by Memorial Sloan Kettering Cancer Center 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 6 inclusion and 20 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: finished, as of the sponsor's last update on 16 Apr 2020. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
VO2peak (time frame: 1 year). 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 16 Apr 2020; AzTrials last refreshed its copy on 4 Nov 2026.