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Study on Treatment Intensity for Acute Myeloid Leukemia and Myeloid Neoplasms

This study is for adults with acute myeloid leukemia (AML) or other myeloid neoplasms (blood cancers) who may be considered less fit for standard intensive chemotherapy. Researchers want to see if patients and their doctors are willing to let a computer program decide whether they receive a lower-intensity or higher-intensity treatment. Historically, treatment decisions for these conditions have been based on a patient's fitness, with fitter patients receiving intensive therapy and less fit patients receiving less intensive or no therapy. This study aims to understand the feasibility of using randomization to assign treatment intensity. You would be eligible if you are 18 or older and have a high-grade myeloid neoplasm, excluding acute promyelocytic leukemia. The study is currently unclear on its recruitment status and plans to enroll 50 participants. Success for this study means understanding how willing patients are to be randomized.

Study design
This is an interventional study exploring the feasibility of randomizing patients to different treatment intensities. It plans to enroll 50 participants.
What's involved
You would undergo blood and bone marrow collection, and your electronic health records would be reviewed. You would also complete questionnaires.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint, willingness to randomize, is measured at baseline.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07094750

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

Recruiting
NAAges 18+InterventionalHealth services
Fred Hutchinson Cancer Center
~50 participants
Updated 2026-08-12 on ClinicalTrials.gov
What's tested:Biospecimen CollectionBone Marrow CollectionElectronic Health Record ReviewQuestionnaire Administration

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Willingness to randomize (Feasibility)
Measured over At baseline

Conditions

Acute Leukemia of Ambiguous Lineage
Acute Myeloid Leukemia
Myeloid Neoplasm

Explore related trials

Acute Leukemia of Ambiguous LineageAcute Myeloid LeukemiaMyeloid Neoplasm

Where it's being run

1 sites across 1 states
Washington1

Study leadership

  • Jacob Appelbaum, MD, PhD · PRINCIPAL_INVESTIGATOR · Fred Hutch/University of Washington Cancer Consortium

Who to contact

Jacob Appelbaum, MD, PhD
[email protected]
206-606-4643
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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):
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

Exclusion

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

What this trial measures

  • Willingness to randomize (Feasibility)At baseline

    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.