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Palliative Care for Leukemia
Phase 2
Recruiting
Led By Firas El Chaer, MD
Research Sponsored by University of Virginia
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
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
Patients with refractory AML, ALL, high risk MDS or high risk CMML, ages 18 and older
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from enrollment through participant death or study completion, an average of 2 years.
Awards & highlights
Study Summary
This trial will test whether early and continued palliative care consultation can help improve end of life care.
Who is the study for?
This trial is for adults aged 18 and older with a new or relapsed diagnosis of acute myeloid leukemia (AML), acute lymphoblastic leukemia (ALL), high-risk myelodysplastic syndrome (MDS), or chronic myelomonocytic leukemia (CMML). Participants must be able to consent, follow the study plan, and not have Acute Promyelocytic Leukemia.Check my eligibility
What is being tested?
The trial studies the impact of early and ongoing palliative care consultations on end-of-life issues for patients with certain high-risk leukemias or MDS. It aims to understand how this supportive care can benefit these individuals.See study design
What are the potential side effects?
Since the intervention involves palliative care visits rather than medication, typical drug side effects are not expected. However, discussing end-of-life issues may bring emotional discomfort.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 65 or older with a new diagnosis of AML, ALL, high-risk MDS, or high-risk CMML.
Select...
I am 18 or older with a specific type of blood cancer that has not responded to treatment.
Select...
My leukemia has not responded to at least two rounds of chemotherapy.
Select...
I am 18 or older with a relapse of AML, ALL, high-risk MDS, or CMML.
Select...
My MDS does not respond to standard treatments.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from enrollment through participant death or study completion, an average of 2 years.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from enrollment through participant death or study completion, an average of 2 years.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Place of death
Secondary outcome measures
Code status change
Duration of hospitalizations
Emergency department visits
+7 moreTrial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Palliative Care InterventionExperimental Treatment1 Intervention
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.
Group II: Standard Clinical CareActive Control1 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.
Find a Location
Who is running the clinical trial?
University of VirginiaLead Sponsor
754 Previous Clinical Trials
1,244,968 Total Patients Enrolled
Firas El Chaer, MDPrincipal InvestigatorUniversity of Virginia
1 Previous Clinical Trials
17 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am 65 or older with a new diagnosis of AML, ALL, high-risk MDS, or high-risk CMML.I am 18 or older with a specific type of blood cancer that has not responded to treatment.My leukemia has not responded to at least two rounds of chemotherapy.I am 18 or older with a relapse of AML, ALL, high-risk MDS, or CMML.My CMML is not responding to treatment, as determined by my doctor.I do not have Acute Promyelocytic Leukemia.My MDS does not respond to standard treatments.
Research Study Groups:
This trial has the following groups:- Group 1: Palliative Care Intervention
- Group 2: Standard Clinical Care
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are people with the required qualifications still able to join this research project?
"Yes, as stated on clinicaltrials.gov, this study is open for recruitment. This trial was originally posted on August 19th 2020 and updated most recently on April 28th 2022. They are looking for 105 patients from 1 site."
Answered by AI
Has the FDA cleared Palliative Care Visits for use?
"Palliative Care Visits were given a score of 2. This is based on the Phase of the trial (2) which suggests that while there is some data supporting safety, there is no data currently suggesting it's efficacy."
Answered by AI
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