Comparing two types of palliative care for patients with acute myeloid leukemia
Official title: Specialty Compared to Oncology Delivered Palliative Care for Patients With Acute Myeloid Leukemia
Run by Massachusetts General Hospital · NCT05237258 · Data updated 2026-11-12
This study is testing if regular palliative care can help hospitalized patients with acute myeloid leukemia feel better and cope with their illness just as well as specialty palliative care.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 120 Years |
| Sex | All |
| Enrollment | 2300 (estimated) |
| Sponsor | Massachusetts General Hospital Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 20 sites (Birmingham, Alabama and 19 other locations) |
| Status | Recruiting |
| Started | June 1, 2022 |
| Main results expected | April 2028 |
| Study ends | April 2029 |
| Registry record updated | July 25, 2025 |
| Trial ID | NCT05237258 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include hospitalized adults aged 18 and older with high-risk AML or those who are relapsed or primary refractory.
✕Probably not a fit
Patients with acute promyelocytic leukemia or those receiving only supportive care may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This research evaluates whether primary palliative care can serve as an effective alternative to specialty palliative care for patients with acute myeloid leukemia (AML). The study focuses on hospitalized patients who are experiencing significant physical and emotional distress due to their diagnosis and treatment. It aims to improve quality of life, symptoms, mood, coping, and end-of-life outcomes by comparing the two approaches to palliative care. The involvement of caregivers is also considered, as they play a crucial role in the patient's experience during this challenging time.
Why it matters
Potential benefit: If successful, this study could enhance the quality of life and emotional well-being of patients with acute myeloid leukemia.
How similar studies have gone: Previous studies have shown that both specialty and primary palliative care approaches can improve patient outcomes, indicating that this study builds on established findings.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patient Inclusion Criteria * Hospitalized patients (age ≥ 18 years) with high-risk AML defined as: * Patients with new diagnosis ≥ 60 years of age * An antecedent hematologic disorder * Therapy related-disease * Relapsed or primary refractory AML * Within five business days of initiating therapy with either a) intensive chemotherapy (7+3) or modification of this regimen on a clinical trial, or a similar intensive regimen requiring prolonged hospitalization; or b) hypomethylating agents +/- additional agents or modification of this regimen on a clinical trial. * Caregiver Inclusion Criteria * Adult (≥18 years) relative or friend of a participating patient who the patient identifies as living with or has in-person contact with them at least twice per week. Exclusion Criteria: \- Patient Exclusion Criteria * Patients with a diagnosis of acute promyelocytic leukemia (APML) * Patients with AML receiving supportive care alone * Patients with psychiatric or cognitive conditions which the treating clinicians believe prohibits informed consent or compliance with study procedures * Patients seen by a palliative care clinician (MD, DO, APP) during two previous hospitalizations in the six months prior to enrollment * Patients expected to be discharged within 2 days
Where it's running
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University of Alabama - Birmingham
Birmingham, Alabama, United States Recruiting -
Stanford University
Stanford, California, United States Recruiting -
University of Colorado Denver I Anschutz Medical Campus
Denver, Colorado, United States Recruiting -
University of Miami
Miami, Florida, United States Recruiting -
Moffitt Cancer Center
Tampa, Florida, United States Recruiting -
Emory University
Atlanta, Georgia, United States Recruiting
Show 14 more locations
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Northwestern University
Evanston, Illinois, United States Recruiting -
Indiana University
Bloomington, Indiana, United States Recruiting -
Johns Hopkins University
Baltimore, Maryland, United States Recruiting -
Massachusetts General Hospital
Boston, Massachusetts, United States Recruiting -
Dana-Farber Cancer Institute
Boston, Massachusetts, United States Recruiting -
Mayo Clinic
Rochester, Minnesota, United States Recruiting -
University of Rochester
Rochester, New York, United States Recruiting -
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States Recruiting -
Duke University
Durham, North Carolina, United States Recruiting -
Ohio State University
Columbus, Ohio, United States Recruiting -
Oregon Health & Science University
Portland, Oregon, United States Recruiting -
University of Pennsylvania
Philadelphia, Pennsylvania, United States Recruiting -
Fred Hutchinson Cancer Center
Seattle, Washington, United States Recruiting -
University of Wisconsin
Madison, Wisconsin, United States Recruiting
Study contacts
- Principal investigator: Areej El-Jawahri, MD — Massachusetts General Hospital
- Study coordinator: Areej El-Jawahri, MD
- Email: ael-jawahri@partners.org
- Phone: 617-724-4000
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Adapt NK cells for high-risk AML bridging to stem cell transplant
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Donor γδ T cell infusion to prevent relapse after stem cell transplant in high‑risk AML
This will test whether a donor γδ T cell infusion given soon after an allogeneic stem cell transplant can help prevent relapse in adults (18–65) with high‑risk acute myeloid leukemia.
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Venetoclax-enhanced BUCY versus standard BUCY conditioning for high‑risk AML and MDS before allogeneic stem cell transplant
This will test whether adding venetoclax to BUCY conditioning before allogeneic stem cell transplant helps patients aged 12–60 with high‑risk AML or MDS stay in remission longer.
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Using CD45RA Depleted Stem Cells to Prevent Infections After Transplant
This study is testing whether using special stem cells can help patients with high-risk leukemia recover their immune system faster and prevent infections after a stem cell transplant.
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CD19 CAR-T therapy for adults with relapsed CD19-positive AML
This will try CD19-directed CAR-T cell therapy in adults with relapsed or refractory AML whose leukemia cells express CD19.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.