Acute Myeloid Leukemia (AML)ACTIVE DEFAULTNCT07777471
Improving Delivery of Aging-Related Supportive Care for Older Adults With Acute Myeloid Leukemia
A study testing Active Default in people with Acute Myeloid Leukemia (AML), run by University of Alabama at Birmingham at 1 site in United States.
Trial summary
The goal of this clinical trial is to test a way of delivering supportive care to adults 60 years and older who are starting venetoclax-based treatment for newly diagnosed acute myeloid leukemia (AML). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Acute Myeloid Leukemia (AML)
- What is being tested?
- Active Default
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2027to 30 Sep 2028
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patient participants:
- Age 60 years or older
- Newly diagnosed acute myeloid leukemia (AML), including de novo, secondary, or therapy-related AML, per current World Health Organization (WHO) or International Consensus Classification (ICC) classification
- Planned for first-line venetoclax-based lower-intensity therapy
- English-speaking
- Able to provide informed consent personally or through a Legally Authorized Representative (LAR)
- Provider participants:
- -Participating leukemia attending physicians and supportive care service leads involved in the care of enrolled participants
Who cannot join
- Patient participants:
- Acute promyelocytic leukemia
- Planned intensive induction or non-venetoclax-based therapy
- Life expectancy under 14 days or hospice enrollment at screening
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
University of Alabama at Birmingham
Birmingham, Alabama, 35233
Aditi Sharma, MD, 205-975-0412, adshar@uabmc.edu
Aditi Sharma, MD
About this study
Official title: Active Default Pilot: Implementation of Geriatric Assessment-Driven Supportive Care for Older Adults With Acute Myeloid Leukemia Receiving Venetoclax-Based Therapy
The goal of this clinical trial is to test a way of delivering supportive care to adults 60 years and older who are starting venetoclax-based treatment for newly diagnosed acute myeloid leukemia (AML). Older adults with AML often have aging-related needs, such as problems with mobility, nutrition, mood, memory, or medications, that are not always addressed in a consistent way. In this study, a health questionnaire and short in-person checks (a geriatric assessment) are used to find these needs early, and matching supportive care orders are prepared in the electronic health record and sent to the treating doctor, who decides whether to place each one. This approach is called Active Default. The main questions the study aims to answer are:
- How often are the prepared supportive care orders signed by treating doctors (implementation fidelity)?
- Can each step of the process, from completing the assessment to receiving supportive care services, be carried out as planned?
Read more
Participants will:
- Complete questionnaires and short in-person checks of walking, balance, strength, memory, mood, and medications at the start of treatment
- Receive supportive care services (for example physical therapy, nutrition, or social work) if their doctor approves the prepared orders
- Answer phone check-ins over 90 days and repeat two short checks at about two months
- Be invited to one optional interview about their experience
Healthcare providers involved in participants' care will be invited to complete a one-time survey and an optional interview about the approach.
- Conditions
- Acute Myeloid Leukemia (AML)
- Being tested
- Active Default
- Medical subject headings
- Leukemia, Myeloid, Acute
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active DefaultBehavioural
An electronic health record-based order-queuing mechanism that delivers geriatric assessment-driven supportive care. A structured geriatric assessment is completed at the start of venetoclax-based therapy. Results crossing pre-specified thresholds trigger matched supportive care orders (for example physical therapy, nutrition, social work, pharmacy medication review, geriatrics, mental health, chaplaincy), which the study team prepares as proposed orders for the treating physician to approve or decline. The supportive care services themselves are standard of care; the intervention modifies only the order-entry workflow.
| Study group | Role | What they receive |
|---|---|---|
| Active Default | Experimental | Patients aged 60 and older with newly diagnosed AML starting venetoclax-based therapy (n=25) receive the Active Default intervention: a geriatric assessment at the start of treatment, with results crossing pre-specified thresholds generating matched supportive care orders that are prepared in the electronic health record and sent to the treating physician to approve or decline. Patients are followed for 90 days, with phone check-ins and repeat physical function and cognition checks at about 60 days. Healthcare providers involved in enrolled patients' care (up to 15) complete a one-time survey and are invited to an optional interview about the approach. Receives: Behavioral: Active Default |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of eligible triggered supportive care orders signed by the treating physician within 7 days (implementation fidelity)
Measured as the number of eligible geriatric assessment-triggered supportive care orders signed by the treating physician within 7 days of order placement, divided by the total number of eligible triggered orders, using electronic health record order data. Eligible triggers are those not already engaged in the corresponding service or pre-declined by the patient at the pre-referral screen. Reported as a point estimate with 95% Clopper-Pearson confidence interval.
Measured: Within 7 days of each supportive care order placement; orders are placed after the baseline geriatric assessment and within 7 days before or after Cycle 1 Day 1 of venetoclax-based therapy (each cycle is 28 days)
Secondary outcomes (1)
Proportion of signed supportive care orders with at least one completed service visit (service engagement)
Measured as the number of signed supportive care orders with at least one completed visit in the corresponding service within 90 days of Cycle 1 Day 1, divided by the total number of signed orders, using electronic health record data. Reported as a point estimate with 95% Clopper-Pearson confidence interval.
Measured: 90 days from Cycle 1 Day 1, the first day of venetoclax-based therapy (each cycle is 28 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2026
- Study start1 Jan 2027 (estimated)
- Primary completion31 Jul 2028 (estimated)
- Study completion30 Sep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Myeloid Leukemia (AML)Studies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aditi Sharma, University of Alabama at Birmingham
- Investigators
- Aditi Sharma, MD, Principal investigator, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07777471
- Sponsor's protocol ID
- IRB-300016966
- Other IDs
- UAB
- Acronym
- ACTIVE DEFAULT
- Status last verified
- Oct 2026
- First submitted
- 17 Aug 2026
- Last updated
- 13 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No