Tailoring chemo by genetics and health may boost survival in older AML patients
NCT ID NCT03226418
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tested whether matching chemotherapy intensity to a patient's genetic risk and overall health could improve outcomes for older adults (60+) with acute myeloid leukemia. 75 participants received either standard intensive or lower-intensity chemo based on their individual risk profile. Researchers tracked remission rates, survival, and quality of life for up to 2 years.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Cytarabine (chemotherapy)
- What this could lead to
- If successful, this approach could help doctors choose the right chemotherapy intensity for older AML patients, potentially improving survival and quality of life.
- What could go wrong
- This is a small, single-center phase 2 study without a control group, so results may not be widely applicable. Chemotherapy carries risks like infection and organ damage.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
-
75 people
The number who actually took part.
- Started
-
Jul 2017
- Finished
-
Oct 2024
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
60 years and older
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion criteria: * New diagnosis of de novo, secondary or treatment-related acute myeloid leukemia (AML), other AML equivalent such as myeloid sarcoma, myelodysplastic syndrome in transformation to AML, or high-grade treatment-related myeloid neoplasm * 60 years of age or older * Karnofsky Performance Status ≥60% * Able and willingly give signed informed consent Exclusion criteria: * Acute promyelocytic leukemia (APL). Participants with brief exposure to all-trans retinoic acid (ATRA), arsenic trioxide (ATO) or similar product for suspected APL, who later turn out not to have APL, are eligible. * Relapsed or refractory acute myeloid leukemia (AML) requiring salvage therapy * Prior exposure to decitabine or azacitidine (exclusion criterion for use of decitabine or azacitidine) * Participants requiring urgent initiation of chemotherapy for leukemia-related emergencies such as leukostasis or disseminated intravascular coagulopathy Participants will not be excluded solely based on current or prior use of debulking agent (e.g., hydroxyurea or cyclophosphamide). Prior or current use of leukapheresis will be allowed. * Uncontrolled serious infection at enrollment. Infections are considered controlled if appropriate therapy has been instituted and, at enrollment, participants do not have signs of infection progression (e.g., hemodynamic instability attributable to sepsis, new symptoms, worsening physical signs or radiographic findings attributable to infection). Persistent fever without other signs or symptoms will not be interpreted as progressing infection. * Uncontrolled clinically significant arrhythmia, myocardial ischemia or congestive heart failure within the past 2 weeks, that is considered a contraindication for initiation of chemotherapy by the treating physician * Ejection fraction \< 45% will be an exclusion criterion for intensive chemotherapy. These participants may receive low intensity therapy. * Clinically significant kidney (e.g., glomerular filtration rate (GFR) ≤ 45ml/minute or creatinine of ≥2 mg/dl) or liver dysfunction \[e.g., aspartate aminotransferase (AST)/alanine aminotransferase (ALT) and/or bilirubin ≥2 times upper limit of normal (ULN)\] at enrollment that may prevent safe use of chemotherapy. These participants may be allowed to receive low-intensity chemotherapy. Participants with elevated bilirubin secondary to Gilbert syndrome will not be excluded. * Any other condition that may not allow safe use of chemotherapy based on clinical judgment of treating oncologist
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Adult acute myeloid leukemia are added.
Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
University of Nebraska Medical Center
Omaha, Nebraska, 68198, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can adding venetoclax make donor stem cell transplants safer for High-Risk blood cancers?
- Blood cancer registry tracks thousands to map disease course
- Can a pill keep blood cancer at bay after a stem cell transplant?
- Personalizing leukemia care for seniors: a fitness-based treatment strategy put to the test
- Can a liposomal chemo combo outsmart tough leukemias?
- Can a Platelet-Boosting drug speed recovery for older leukemia patients?