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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

Must not have

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from enrollment through participant death or study completion, an average of 2 years.

Awards & highlights

No Placebo-Only Group

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.

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.

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 below

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I am 65 or older with a new diagnosis of AML, ALL, high-risk MDS, or high-risk CMML.

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I am 18 or older with a specific type of blood cancer that has not responded to treatment.

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My leukemia has not responded to at least two rounds of chemotherapy.

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I am 18 or older with a relapse of AML, ALL, high-risk MDS, or CMML.

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My MDS does not respond to standard treatments.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I do not have Acute Promyelocytic Leukemia.

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.

This trial's timeline: 3 weeks for screening, Varies for treatment, and from enrollment through participant death or study completion, an average of 2 years. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Place of death

Secondary study objectives

Code status change

Duration of hospitalizations

Emergency department visits

+7 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial 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.

0 / 6Eligibility criteria met