Leukemia, AcuteNCT04482894
Palliative Care Oncology in Patients With Relapsed, Refractory, and High-Risk Leukemias or MDS
A study testing Palliative Care Visits in people with Leukemia, Acute and AML, Adult, run by University of Virginia at 1 site in United States.
Trial summary
The purpose of this study is to estimate the potential benefit of early and continued palliative care (PC) consultation on end of life issues. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Leukemia, Acute, AML, Adult, ALL, Adult
- What is being tested?
- Palliative Care Visits
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 105 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Aug 2020to 1 Jun 2027
- Phase
- Interventional
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Ability to provide informed consent
- Stated willingness to comply with all study procedures and availability for the duration of the study
- Any of the following:
- Patients with a new diagnosis of AML, ALL, high risk myelodysplastic syndrome (MDS), or high risk chronic myelomonocytic leukemia (CMML) who are age 65 and older.
- OR
- Patients with relapsed AML, ALL, high risk MDS or high risk CMML, ages 18 and older.
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- OR
- Patients with refractory AML, ALL, high risk MDS or high risk CMML, ages 18 and older.
- Refractory AML/ALL will be defined as persistent leukemia despite two or more cycles of induction chemotherapy.
- Refractory MDS will be defined according to the 2006 IWG response criteria Refractory CMML will be based on the assessment of the treating investigator.
Who cannot join
- 1. Participants must not have a diagnosis of Acute Promyelocytic Leukemia (APL)
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Virginia
Charlottesville, Virginia, 22903
About this study
Official title: Palliative Care Oncology in Patients With Relapsed, Refractory, and High-Risk Leukemias or High-Risk Myelodysplastic Syndrome: Randomized Phase II Study
The purpose of this study is to estimate the potential benefit of early and continued palliative care (PC) consultation on end of life issues.
Read the detailed description
Participants in this study will be randomized to either an intervention group or a standard of care group. Participants in the intervention group will participate in regular visits with a palliative (or supportive) care specialist, while participants in the standard of care group will only see palliative care specialists if the clinician requests a referral. All participants will be asked to complete monthly questionnaires regarding their general well-being.
Participants have a greater chance of being assigned to the intervention group than to the standard of care group. On average, in every 5 people randomized, 3 will be randomized to the intervention and 2 will be randomized to standard of care.
- Conditions
- Leukemia, Acute, AML, Adult, ALL, Adult, Myelodysplastic Syndromes
- Being tested
- Palliative Care Visits
- Medical subject headings
- Leukemia, Leukemia, Myeloid, Acute, Precursor Cell Lymphoblastic Leukemia-Lymphoma, Myelodysplastic Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Palliative Care VisitsOther
Regular visits with a palliative (supportive) care specialist
| Study group | Role | What they receive |
|---|---|---|
| Palliative Care Intervention | Experimental | Participants on this arm will see a palliative care specialist twice a week while they are in the hospital and about every other week when they are out of the hospital. If participants see their oncologist less often than every other week while they're out of the hospital, then visits with the palliative care specialist would be timed to occur on the same day as the oncologist visit. Participants will complete a questionnaire about once a month. Receives: Other: Palliative Care Visits |
| Standard Clinical Care | No intervention | Participants will see a palliative care specialist only if they have a referral from their oncologist according to standard clinical care. Participants on this arm will not be discouraged from requesting a consult. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Place of death
Location of death (ICU, inpatient floor, hospice, home)
Measured: At the time of death (for participants that die), assessed from enrollment through study completion, an average of 2 years
Secondary outcomes (10)
Overall survival
Time from enrollment through death (for participants that die)
Measured: From enrollment through participant death or end of study from enrollment through participant death or study completion, an average of 2 years.
Duration of hospitalizations
Duration of hospitalizations
Measured: From enrollment through participant death or study completion, an average of 2 years.
Type(s) of hospitalizations
Type(s) of hospitalizations
Measured: From enrollment through participant death or study completion, an average of 2 years.
Frequency of hospitalizations
Frequency of hospitalizations
Measured: From enrollment through participant death or study completion, an average of 2 years.
Emergency department visits
Frequency/Number of emergency department visits
Measured: From enrollment through participant death or study completion, an average of 2 years.
Hospice services use
Dates of use of hospice services
Measured: From enrollment through participant death or study completion, an average of 2 years.
Transfusions
Frequency/number and types of transfusions received
Measured: From enrollment through participant death or study completion, an average of 2 years.
Quality of life measure
Quality of life based on FACT-Leukemia questionnaire, scored from 0 to 176, with a higher score indicating better quality of life
Measured: At time of enrollment, and then once a month during participation through participant death or study completion, an average of 2 years.
Code status change
Dates and types of changes to code status (e.g. Do not rescuscitate (DNR) with details)
Measured: From enrollment through participant death or study completion, an average of 2 years.
Goals of Care (GOC) Discussions
Whether a GOC discussion occurs while on study, and if so, date and location of discussion
Measured: From enrollment through participant death or study completion, an average of 2 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2020
- Study start19 Aug 2020
- Primary completion9 May 2027 (estimated)
- Study completion1 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Leukemia, AcuteStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 105 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Virginia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Karen Ballen, MD, University of Virginia
- Investigators
- Karen Ballen, MD, Principal investigator, University of Virginia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04482894
- Sponsor's protocol ID
- HSR 200133
- Status last verified
- Apr 2026
- First submitted
- 8 Jul 2020
- Last updated
- 4 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No