Palliative Care Oncology in Patients With Relapsed, Refractory, and High-Risk Leukemias or MDS

Last updated: May 12, 2025
Sponsor: University of Virginia
Overall Status: Active - Not Recruiting

Phase

2

Condition

White Cell Disorders

Leukemia

Myelodysplastic Syndromes (Mds)

Treatment

Palliative Care Visits

Clinical Study ID

NCT04482894
HSR 200133
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Ability to provide informed consent

  2. Stated willingness to comply with all study procedures and availability for theduration of the study

  3. Any of the following:

  4. Patients with a new diagnosis of AML, ALL, high risk myelodysplastic syndrome (MDS), or high risk chronic myelomonocytic leukemia (CMML) who are age 65 andolder.OR

  5. Patients with relapsed AML, ALL, high risk MDS or high risk CMML, ages 18 andolder.OR

  6. Patients with refractory AML, ALL, high risk MDS or high risk CMML, ages 18 andolder.

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.

Exclusion

Exclusion Criteria:

  1. Participants must not have a diagnosis of Acute Promyelocytic Leukemia (APL)

Study Design

Total Participants: 105
Treatment Group(s): 1
Primary Treatment: Palliative Care Visits
Phase: 2
Study Start date:
August 19, 2020
Estimated Completion Date:
April 01, 2026

Study 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.

Connect with a study center

  • University of Virginia

    Charlottesville, Virginia 22903
    United States

    Site Not Available

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