Randomization for the Identification of Best Treatment Intensity for Less Fit Adults With Acute Myeloid Leukemia and Myeloid Neoplasms
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
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 18 Years and older
- Sex
- All sexes
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
- Time periods mentioned: 24 months
- Procedures mentioned: Blood draws
Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.
Show the study's own words
- "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."
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study asks whether less fit adults with acute myeloid leukemia (AML) or related blood cancers will let a computer assign their treatment by chance. The computer chooses lower- or higher-intensity chemotherapy. This may help find the best treatment strength for these adults.
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.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- Be age 18 or older.
- Have a qualifying blood cancer with more than 10% blasts (immature blood cells) in the blood or bone marrow. Leukemia with an unclear cell type may also qualify, but acute promyelocytic leukemia (APL) does not.
- Meet the study’s limits on daily activity. People under 75 may need more help with daily tasks than those 75 or older.
- Have at least one reason that strong chemotherapy may be hard to tolerate, such as limits on daily activity or certain heart, lung, kidney, liver, or other health problems.
- Meet the study’s heart and liver test requirements. Some exceptions apply when leukemia or certain other conditions cause abnormal liver tests.
- Earlier treatment for a less advanced blood cancer is allowed. Treatment to lower blood cell counts before the study is also allowed, with limits on cytarabine use.
- If able to have or father a child, agree to use birth control during treatment and for the required time afterward.
- Be able to understand the study and agree to take part. People with HIV may qualify if treatment is working and the virus was undetectable within the past 6 months.
Who can't join
- Have a known allergy to cytarabine, anthracyclines, hypomethylating drugs, or venetoclax.
- Have heart disease that causes tiredness, a racing heartbeat, shortness of breath, or chest pain during ordinary activity, or more severe heart limits.
- Have long-term lung disease that requires oxygen all the time.
- Have another major health condition that the study doctor thinks would make taking part unsafe or difficult.
- Have a significant infection that is not controlled and needs treatment.
- Have another illness that is likely to limit life to less than 1 year.
- Be pregnant or breastfeeding.
Simplified for readability. The official criteria below are what the study team uses.
Official eligibility criteria
Inclusion Criteria: * 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 Criteria: * 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
Study sites (1)
WA
- Fred Hutch/University of Washington Cancer Consortium · Seattle, WA 98109Jacob Appelbaum, MD, PhD · Study contact · 206-606-4643 · jappelb@uw.eduJacob Appelbaum, MD, PhD · Principal investigatorMore trials in Seattle