Image

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

Recruiting
18 years of age
Both
Phase 2

Powered by AI

Overview

The purpose of this study is to estimate the potential benefit of early and continued palliative care (PC) consultation on end of life issues.

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.

Eligibility

Inclusion Criteria:

  1. Ability to provide informed consent
  2. Stated willingness to comply with all study procedures and availability for the duration of the study
  3. Any of the following:
    1. 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

    2. Patients with relapsed AML, ALL, high risk MDS or high risk CMML, ages 18 and older.

      OR

    3. 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.
        Exclusion Criteria:
        1. Participants must not have a diagnosis of Acute Promyelocytic Leukemia (APL)

Study details

Leukemia, Acute, AML, Adult, ALL

NCT04482894

University of Virginia

26 January 2024

Step 1 Get in touch with the nearest study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer  to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact

site

FAQs

Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

How long does a clinical trial take place?

The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

Do I get compensated for taking part in clinical trials?

Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

How safe are clinical trials?

Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
Add a private note
  • abc Select a piece of text.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.