AzTrials
AzTrials

Acute Leukemia of Ambiguous LineageNCT07094750

Randomization for the Identification of Best Treatment Intensity for Less Fit Adults With Acute Myeloid Leukemia and Myeloid Neoplasms

A study testing Biospecimen Collection, Bone Marrow Collection and Electronic Health Record Review in people with Acute Leukemia of Ambiguous Lineage and Acute Myeloid Leukemia, run by Fred Hutchinson Cancer Center at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

This clinical trial studies whether less fit adults with acute myeloid leukemia (AML) or myeloid neoplasms are willing to let a computer program decide (randomization) whether they receive lower- or higher-intensity chemotherapy. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Biospecimen Collection, Bone Marrow Collection and Electronic Health Record Review
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
1 siteUnited States
Study dates
13 Oct 2026to 8 Jun 2029
Phase
Interventional
Are there results?
Not yet: the study is under way

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
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age ≥ 18 years
  • Diagnosis of high grade myeloid neoplasm (> 10% blasts in blood or marrow), other than acute promyelocytic leukemia (APL) according to the 2022 International Consensus Classification (ICC) classification. Patients with acute leukemias of ambiguous lineage are eligible
  • The use of cytoreductive therapy before treatment is permitted. Patients with symptoms/signs of leukostasis, white blood cell (WBC) > 100,000/μL, or acute symptoms that in the opinion of the treating physician are likely related to their high-grade myeloid neoplasm may receive up to 2 doses of cytarabine (up to 500 mg/m^2 each) prior to study day 1
  • Patients may have received treatment for antecedent low-grade myeloid neoplasm (< 10% myeloid blasts on blood or bone marrow)
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 - 3 (for patients aged < 75 years) or ECOG performance status of 0 - 2 (for patients aged ≥ 75 years)
  • The presence of one or more of the following criteria for 'unfitness'. (Patients without respiratory symptoms at rest are eligible and should only complete spirometry/diffusion capacity of the lung for carbon monoxide [DLCO] measurements as clinically indicated):
Show all 23Show fewer
  • ECOG Performance Status of 2 or 3
  • Cardiac history of congestive heart failure (CHF) requiring treatment or ejection fraction ≤ 50% or chronic stable angina
  • Documented DLCO ≤ 65% or forced expiratory volume in 1 second (FEV1) ≤ 65%; or dyspnea at rest, or requiring supplemental oxygen
  • Creatinine clearance ≥ 30 mL/min to < 45 ml/min
  • Moderate hepatic impairment with total bilirubin > 1.5 to ≤ 3.0 × upper limit of normal (ULN)
  • Any other comorbidity that the physician judges to be incompatible with intensive chemotherapy
  • Adequate cardiac function:
  • Patients aged ≤ 60 years without a history of cardiac disease or evidence of heart failure are eligible if they also exhibit the following:
  • Chest x-ray (CXR) without evidence of moderate or severe pulmonary edema or pleural effusion, and a normal cardio-mediastinal silhouette
  • Electrocardiogram (ECG) without evidence of atrial or ventricular chamber enlargement
  • Note that patients with either abnormal CXR or ECG should have a structural heart assessment (echocardiogram, multigated acquisition scan [MUGA] or similar) and are eligible if left ventricular ejection fraction (LVEF) > 40% and the abnormalities in the CXR/ECG do not preclude safe administration of intensive chemotherapy
  • Patients with a documented left ventricular ejection fraction (LVEF) ≥ 40%, assessed within 3 months prior to registration, e.g. by MUGA scan or echocardiography, or another appropriate diagnostic modality are eligible
  • Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3x ULN, unless judged due to leukemic organ involvement
  • Total bilirubin ≤ 3 x ULN unless judged due to leukemic organ involvement, Gilbert's syndrome, or hemolysis
  • Women of childbearing potential and men must agree to use adequate contraception for an appropriate period of time during and after the completion of study treatment
  • HIV-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial
  • Ability to understand and the willingness to provide informed consent

Who cannot join

  • Known hypersensitivity to cytarabine, anthracycline, hypomethylating agents, or venetoclax
  • Cardiovascular disability status of New York Heart Association class ≥ 2. Class 2 is defined as cardiac disease in which patients are comfortable at rest but ordinary physical activity results in fatigue, palpitations, dyspnea, or anginal pain
  • Subject has chronic respiratory disease that requires continuous oxygen, or significant history of renal, neurologic, psychiatric, endocrinologic, metabolic, immunologic, hepatic, cardiovascular disease, or any other medical condition that in the opinion of the investigator would adversely affect his/her participating in this study
  • Subject exhibits evidence of other clinically significant uncontrolled systemic infection requiring therapy (viral, bacterial or fungal)
  • Concomitant illness associated with a likely survival of < 1 year
  • Active pregnancy or breast feeding

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Jacob Appelbaum, MD, PhD contact

206-606-4643

jappelb@uw.edu

United States1 site, 1 recruiting
  • Fred Hutch/University of Washington Cancer Consortium

    Seattle, Washington, 98109

    Jacob Appelbaum, MD, PhD, 206-606-4643, jappelb@uw.edu

    Jacob Appelbaum, MD, PhD

    Recruiting

Other trials in United States

About this study

Official title: Impact of Treatment Intensity on Survival, Quality of Life, and Resource Utilization in Medically Less Fit Adults With Acute Myeloid Leukemia or High-Grade Myeloid Neoplasms: A Randomized Pilot Study

This clinical trial studies whether less fit adults with acute myeloid leukemia (AML) or myeloid neoplasms are willing to let a computer program decide (randomization) whether they receive lower- or higher-intensity chemotherapy. Historically, treatment decision-making for patients with AML or myeloid neoplasms has divided patients into two categories, with patients considered fit receiving intensive "curative" chemotherapy, and patients considered unfit, such as older patients with a higher risk of early death from therapy, receiving non-intensive "palliative" therapy or no therapy. With the introduction of new treatment agents, it has become difficult to determine the difference between intensive and non-intensive therapy, especially for patients considered unfit for whom treatment-related side effects remain a concern. Treatment intensity is best identified through randomized trials but often patients are unwilling to undergo randomization due to preset beliefs. However, with improved supportive care and the awareness that new treatment agents may have similar risks as intensive therapy, it may be possible that more patients are willing to be randomized. This may help identify the best treatment intensity for less fit adults with AML or myeloid neoplasms, which may improve outcomes.

Read the detailed description

OUTLINE:

This pilot umbrella trial will explore the feasibility of randomizing patients to higher or lower intensity treatment regimens.

The exact treatment regimens given will be at the discretion of the treating physician and will be provided either as standard of care or following enrollment on a subsequent treatment trial.

Patients and physicians indicate willingness to randomize, those willing are randomized to 1 of 2 arms, those unwilling choose arm III or IV.

ARM I: Patients receive standard of care (SOC) or investigational higher-intensity therapy on a subsequent treatment trial that is at least as intense as seven days of cytarabine in combination with three days of anthracycline (7+3 regimen) at the discretion of the treating physician on study. Treatment continues in the absence of disease progression or unacceptable toxicity.

ARM II: Patients receive SOC or investigational lower-intensity therapy on a subsequent treatment trial that is less intense than five days of cytarabine in combination with two days of anthracycline (5+2 regimen) at the discretion of the treating physician on study. Treatment continues in the absence of disease progression or unacceptable toxicity.

ARM III: Patients receive SOC or investigational higher-intensity therapy on a subsequent treatment trial that is at least as intense as 7+3 regimen according to physician/patient preference on study. Treatment continues in the absence of disease progression or unacceptable toxicity.

ARM IV: Patients receive SOC or investigational lower-intensity therapy on a subsequent treatment trial that is less intense than 5+2 regimen according to physician/patient preference on study. Treatment continues in the absence of disease progression or unacceptable toxicity.

Additionally, all patients undergo bone marrow assessments or blood sample collection on study, with additional assessments or collections as clinically indicated.

After completion of study treatment, patients are followed up periodically for up to 24 months.

Being tested
Biospecimen Collection, Bone Marrow Collection, Electronic Health Record Review, Questionnaire Administration
Medical subject headings
Leukemia, Biphenotypic, Acute, Leukemia, Myeloid, Acute

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Biospecimen CollectionProcedure or surgery

    Also called Biological Sample Collection, Biospecimen Collected, Specimen Collection

    Undergo blood sample collection

  • Bone Marrow CollectionProcedure or surgery

    Also called Collection, Bone Marrow

    Undergo bone marrow assessment

  • Electronic Health Record ReviewOther

    Ancillary studies

  • Questionnaire AdministrationOther

    Ancillary studies

Study groups in NCT07094750
Study groupRoleWhat they receive
Arm I (randomized higher-intensity therapy)ExperimentalPatients receive SOC or investigational higher-intensity therapy on a subsequent treatment trial that is at least as intense as 7+3 regimen at the discretion of the treating physician on study. Treatment continues in the absence of disease progression or unacceptable toxicity. Additionally, patients undergo bone marrow assessments or blood sample collection on study, with additional assessments or collections as clinically indicated.
Receives: Procedure: Biospecimen Collection; Procedure: Bone Marrow Collection; Other: Electronic Health Record Review; Other: Questionnaire Administration
Arm II (randomized lower-intensity therapy)ExperimentalPatients receive SOC or investigational lower-intensity therapy on a subsequent treatment trial that is less intense than 5+2 regimen at the discretion of the treating physician on study. Treatment continues in the absence of disease progression or unacceptable toxicity. Additionally, patients undergo bone marrow assessments or blood sample collection on study, with additional assessments or collections as clinically indicated.
Receives: Procedure: Biospecimen Collection; Procedure: Bone Marrow Collection; Other: Electronic Health Record Review; Other: Questionnaire Administration
Arm III (patient choice higher-intensity therapy)Active comparatorPatients receive SOC or investigational higher-intensity therapy on a subsequent treatment trial that is at least as intense as 7+3 regimen according to physician/patient preference on study. Treatment continues in the absence of disease progression or unacceptable toxicity. Additionally, patients undergo bone marrow assessments or blood sample collection on study, with additional assessments or collections as clinically indicated.
Receives: Procedure: Biospecimen Collection; Procedure: Bone Marrow Collection; Other: Electronic Health Record Review; Other: Questionnaire Administration
Arm IV (patient choice lower-intensity therapy)Active comparatorPatients receive SOC or investigational lower-intensity therapy on a subsequent treatment trial that is less intense than 5+2 regimen according to physician/patient preference on study. Treatment continues in the absence of disease progression or unacceptable toxicity. Additionally, patients undergo bone marrow assessments or blood sample collection on study, with additional assessments or collections as clinically indicated.
Receives: Procedure: Biospecimen Collection; Procedure: Bone Marrow Collection; Other: Electronic Health Record Review; Other: Questionnaire Administration

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Willingness to randomize (Feasibility)

    Patient willingness to randomize will be indicated on the survey instrument Patient Preference for Treatment Assignment Survey. Patients who select the box indicating "I am willing to let a coin flip (i.e. computer program) decide whether I receive lower- or higher-intensity chemotherapy" will be considered willing to randomize. Will consider randomization feasible (i.e. a subsequent, larger study would be designed as a randomized trial) if the true proportion of patients willing to be randomized is 60% or higher.

    Measured: At baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Jul 2025
  2. Study start13 Oct 2026
  3. Primary completion8 Jun 2029 (estimated)
  4. Study completion8 Jun 2029 (estimated)

Resources

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
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
50 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07094750
Sponsor's protocol ID
RG1125566
Other IDs
NCI-2025-04530, FHIRB0020966
Status last verified
Jul 2026
First submitted
23 Jul 2025
Last updated
19 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Biospecimen Collection, Bone Marrow Collection and Electronic Health Record Review in people with Acute Leukemia of Ambiguous Lineage and Acute Myeloid Leukemia, run by Fred Hutchinson Cancer Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 23 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 19 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Jacob Appelbaum, MD, PhD (206-606-4643, jappelb@uw.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Willingness to randomize (Feasibility) (time frame: At baseline). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2026.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in