Acute myeloid leukaemia in older or unfit patients
Most people with acute myeloid leukaemia are over 65, and many cannot take intensive chemotherapy. Venetoclax with azacitidine, two gentler drugs, doubled remission rates and lengthened life in this group, replacing the old choice between supportive care and low-dose chemotherapy.
Overview
Fitness for intensive induction is judged on age, performance status, organ function and comorbidity (the Ferrara criteria and geriatric assessment) rather than on a birthday. Older patients also carry worse biology: more adverse karyotypes, TP53 mutations and secondary disease, and fewer favourable NPM1 or core-binding-factor leukaemias. Until 2018 the options were azacitidine or decitabine alone, low-dose cytarabine or supportive care, with median survival under a year.
VIALE-A, reported in 2020, randomised 431 newly diagnosed patients unfit for intensive therapy to venetoclax or placebo with azacitidine: composite complete remission 66.4 percent versus 28.3 percent, median overall survival 14.7 versus 9.6 months (hazard ratio 0.66), and 37.5 percent versus 16.7 percent alive at two years on longer follow-up. The benefit was largest in IDH-mutated and NPM1-mutated disease and smallest in TP53-mutated and FLT3-ITD disease. Venetoclax-azacitidine received full approval in 2020 and is the global standard; glasdegib with low-dose cytarabine is a lesser alternative, and ivosidenib-azacitidine competes in IDH1-mutated disease.
The regimen brings its own problems: prolonged neutropenia and infections, cycles that must be shortened or delayed, tumour lysis at the start, and azole antifungals that raise venetoclax levels. Current trials shorten the venetoclax course, add FLT3, IDH or menin inhibitors as triplets, take responders to reduced-intensity transplant, and test whether some fit older patients do better with venetoclax-azacitidine than with 7+3.
State of the art
- Venetoclax with azacitidine is the worldwide standard for unfit newly diagnosed patients, giving remission to two in three.
- Geriatric assessment, not age alone, decides fitness for intensive treatment.
- Reduced-intensity transplant after low-intensity remission is extending cure to patients in their seventies.
Red cards
From the labels and guidelines behind the standard of care. Your team's thresholds win.- Emergency services nowBleeding or bruising
Bleeding that will not stop, black or bloody stools, or unexplained bruising when platelets are expected to be low.
- Emergency services nowFainting or palpitations
Fainting, near-fainting, or an irregular or racing heartbeat; several kinase inhibitors prolong the QT interval and the labels require ECG and electrolyte monitoring.
- Emergency services nowDifferentiation syndrome
Fever, cough or breathlessness, rapid weight gain or swelling, bone pain, low blood pressure or reduced urine; the labels say to start steroids and monitor at the first suspicion, and the syndrome has been fatal.
- Emergency services nowBlood clot (lenalidomide, pomalidomide, thalidomide)
A swollen painful calf, or sudden breathlessness with chest pain; venous and arterial thromboembolism is a boxed warning and blood-thinning prophylaxis is recommended.
- Emergency services nowTumour lysis syndrome
Nausea, vomiting, muscle cramps, palpitations, seizures, confusion or passing much less urine in the first days of a new dose; the label requires hydration, anti-hyperuricaemic drugs and blood tests around each ramp-up step.
- Check before combiningGilteritinib with Revumenib: major interaction
QT: both Gilteritinib and Revumenib prolong the QT interval (known and known risk).. Avoid other QT-prolonging drugs where possible; check ECG and correct potassium and magnesium before and during treatment.
See all on the product pages:AzacitidineCPX-351 (liposomal daunorubicin-cytarabine)CytarabineCytarabine + anthracycline ('7+3')DecitabineGilteritinibIvosidenibMidostaurinQuizartinibRevumenibVenetoclax·Printable cards in the navigator
Anatomy and lymph node drainage
- Bone marrow (leukaemia, MDS, MPN, myeloma)
- Lymph node germinal centre (lymphomas)
- Spleen
- Blood (leukaemic phase)
- Lytic bone lesions (myeloma)
- Skin and extranodal sites
- Nodes: cervical
- Nodes: axillary
- Nodes: mediastinal
- Nodes: para-aortic and mesenteric
- Nodes: inguinal
Leukaemias, myeloma and MDS live in the marrow and blood; lymphomas grow in lymph nodes and spleen. The node stations are the disease map, not a route of spread, and staging counts them.
- Bone marrow (leukaemia, MDS, MPN, myeloma)Newly diagnosed AML unfit for intensive chemotherapy (age 75 or over, or comorbidity) · AML in fit older patients (60 to 75) eligible for intensive therapy or CPX-351 · IDH- or NPM1-mutated AML in unfit patients (best responders to venetoclax-azacitidine) · TP53-mutated AML in unfit patients · Relapsed AML after venetoclax-azacitidine
- Lymph node germinal centre (lymphomas)TP53-mutated AML in unfit patients
- Spleen
- Blood (leukaemic phase)
- Lytic bone lesions (myeloma)
- Skin and extranodal sites
- cervical
- axillary
- mediastinal
- para-aortic and mesenteric
- inguinal
In lymphoma the node stations are the disease itself; staging (Ann Arbor / Lugano) counts how many regions and sides of the diaphragm are involved.
Same organ: Marginal zone lymphoma, Cutaneous T-cell lymphoma (mycosis fungoides and Sezary syndrome), Primary mediastinal (thymic) large B-cell lymphoma, Leukaemia (all types), Acute myeloid leukaemia, Acute lymphoblastic leukaemia, Chronic lymphocytic leukaemia, Chronic myeloid leukaemia (CML), Diffuse large B-cell lymphoma, Follicular lymphoma, Hodgkin lymphoma, Mantle cell lymphoma, Multiple myeloma, Non-Hodgkin lymphoma (all types), Myelodysplastic syndromes / neoplasms (MDS), Myeloproliferative neoplasms (PV, ET, myelofibrosis), Polycythaemia vera (PV), Essential thrombocythaemia (ET), Waldenström macroglobulinaemia, Hairy cell leukaemia, Peripheral T-cell lymphomas (including cutaneous T-cell lymphoma), Blastic plasmacytoid dendritic cell neoplasm (BPDCN), Burkitt lymphoma, HIV-associated (AIDS-related) lymphomas, Chronic myelomonocytic leukaemia and MDS/MPN overlap neoplasms, Systemic mastocytosis, Erdheim-Chester disease, Rosai-Dorfman disease and other histiocytic neoplasms, Langerhans cell histiocytosis (LCH), Post-transplant lymphoproliferative disorder (PTLD), FLT3-mutated acute myeloid leukaemia, IDH1- and IDH2-mutated acute myeloid leukaemia, NPM1-mutated and KMT2A-rearranged acute myeloid leukaemia, Secondary and therapy-related acute myeloid leukaemia, Acute promyelocytic leukaemia, Smouldering multiple myeloma, Newly diagnosed multiple myeloma, transplant-eligible, Newly diagnosed multiple myeloma, transplant-ineligible, Relapsed or refractory multiple myeloma, Plasma cell leukaemia, Lower-risk myelodysplastic syndromes, Higher-risk myelodysplastic syndromes, Chronic lymphocytic leukaemia, first treatment, Relapsed or refractory chronic lymphocytic leukaemia, Richter transformation of chronic lymphocytic leukaemia, Chronic myeloid leukaemia, chronic phase, Chronic myeloid leukaemia, accelerated and blast phase, Primary myelofibrosis
The median age at diagnosis of acute myeloid leukaemia is about 68, and roughly half of patients are judged unable to withstand intensive chemotherapy because of age, frailty or other illnesses.
- G8 geriatric screening toolEstablished
Nothing recorded yet.
Nothing recorded yet.
Also on OnCo: Symptoms and red flags · Early detection roadmap.
Cases by country
No country-level case numbers. This cancer is not mapped to a GLOBOCAN site.
One section per setting: the options named, what each is for, the trials behind them, the recorded trade-offs and the questions to ask.
Venetoclax plus azacitidine (VIALE-A) or venetoclax plus decitabine; ivosidenib plus azacitidine for IDH1-mutated disease; targeted triplets in trials.
7+3 or CPX-351 for secondary disease, with a FLT3 inhibitor where indicated, and reduced-intensity allogeneic transplant in remission.
Hydroxyurea for count control, transfusion support and palliative care; low-dose cytarabine or glasdegib combinations where tolerated.
Genotype-directed drugs (gilteritinib, IDH inhibitors, menin inhibitors) or trials; transplant for the few who respond.
Subtypes & biomarkers
top- Newly diagnosed AML unfit for intensive chemotherapy (age 75 or over, or comorbidity)
- AML in fit older patients (60 to 75) eligible for intensive therapy or CPX-351
- IDH- or NPM1-mutated AML in unfit patients (best responders to venetoclax-azacitidine)
- TP53-mutated AML in unfit patients
- Relapsed AML after venetoclax-azacitidine
How often this target appears
- 2004Azacitidine approved for myelodysplastic syndromes, then adopted for low-blast AML
- 2018Venetoclax and glasdegib combinations gain accelerated approval for unfit AML
- 2020VIALE-A: venetoclax plus azacitidine lengthens life; full approval
- 2022AGILE: ivosidenib plus azacitidine for unfit IDH1-mutated patients
Dated changes read from the records linked to this cancer: approvals, regulatory steps, reported trials, guideline versions and milestones. Newest first; no date is inferred.
All 8 changes by month →- 2026-09-17This recordAcute myeloid leukaemia in older or unfit patientsFacts on this page last checked
When this page itself was last checked or edited.
- 2022Trial resultAGILEAGILE reported
OS 24.
- 2022MilestoneAGILEAGILE: ivosidenib plus azacitidine for unfit IDH1-mutated patients
A milestone in how this cancer is treated.
- 2020-10-16RegulatoryAzacitidineAzacitidine: approval (US)
Venetoclax + azacitidine full approval in unfit AML (VIALE-A)
- 2020Trial resultVIALE-AVIALE-A reported
OS 14.
- 2020MilestoneVIALE-AVIALE-A: venetoclax plus azacitidine lengthens life; full approval
A milestone in how this cancer is treated.
What is in development for Acute myeloid leukaemia in older or unfit patients, drawn from the whole corpus: 4 items. Drugs are grouped by the most advanced trial phase they have reached anywhere; approved treatments sit under standard of care. Technologies are the methods being tested for this cancer, trials are the studies recorded here, and ideas are proposals not yet in a trial.
Trials under way · 1
- myeloMATCH · phase platform · NCI / National Clinical Trials Network
Trials reported · 1
- VIALE-A · phase 3 · 2020 · positive
Combinations being explored · 1
Ideas not yet in a trial · 1
Open problems and what is being done
How long venetoclax needs to be given, and whether MRD-negative patients can stop.
and how the field plans to fix it →What is being done about thisRecurrence and residual diseaseAvailable now- GilteritinibApproved
In trials- myeloMATCHRecruiting
Ideas and roadmapsNothing recorded yet.
Also on OnCo: Treatment journeys · Survivorship planner.
Whether fit older patients do better with venetoclax-azacitidine than with intensive chemotherapy.
Infections and cytopenias that keep older patients in hospital during a treatment meant to be gentle.
Trials
topTrials recruiting now
Country and place are remembered in this browser only. A postcode is sent to OpenStreetMap's Nominatim service to find coordinates when you press the button; nothing else leaves your device.
Landmark trials
Expert centres
topExpert centres
Bethesda, MD · government | United States | none recorded | 1 | 2,905 | 47,715 | - | |
Rochester, NY · cancer center | United States | 0 | 861 | 12,212 | - | ||
Leuven · cancer center | Belgium | none recorded | 0 | 343 | 5,732 | - | |
Los Angeles, CA · cancer center | United States | 0 | 318 | 3,917 | - | ||
Melbourne · research institute | Australia | none recorded | 0 | 298 | 3,639 | - | |
Indianapolis, IN · cancer center | United States | 0 | 159 | 4,238 | - | ||
Hamilton, ON · cancer center | Canada | none recorded | 0 | 103 | 1,158 | - | |
Baltimore, MD · cancer center | United States | 0 | 101 | 2,306 | - | ||
Omaha, NE · cancer center | United States | 0 | 37 | 4,159 | - | ||
Rotterdam · consortium | Netherlands | none recorded | 0 | 8 | 207 | - | |
Luxembourg · consortium | Luxembourg | none recorded | 0 | not matched | - | - | |
Minneapolis, MN · cancer center | United States | 0 | not matched | - | - | ||
Aurora, ON · consortium | Canada | none recorded | 0 | not matched | - | - | |
Jerusalem · hospital | Israel | none recorded | 0 | not matched | - | - |
These are the things we can measure; they are not a ranking of quality. Each column is a field on the institution record or a count over what OnCo has linked; a centre that treats many patients with Acute myeloid leukaemia in older or unfit patients but is thinly recorded here will look small.
Not known: OnCo holds no case-volume or outcome figures for centres, so none are shown. Where a national audit or registry publishes them, the centre's page links to it. Default order: Newsweek rank, then trials for this cancer, then research output.
Questions to ask
topQuestions to ask your oncologist about Acute myeloid leukaemia in older or unfit patients
Newly diagnosed
- What is my exact diagnosis, stage, and grade, and which tests established them?Why: Everything else follows from an accurate stage and subtype.
- Which biomarkers have been tested on my tumour (for example Performance status and geriatric assessment, Comorbidity index and organ function, ELN 2022 risk group, IDH1/2, NPM1, FLT3 and TP53 mutations, Measurable residual disease by flow cytometry), and what were the results?Why: These results decide eligibility for targeted therapy, immunotherapy, and trials.
- Which subtype is my cancer, and does that change the recommended treatment?Why: Recognised subtypes for this cancer include Newly diagnosed AML unfit for intensive chemotherapy, AML in fit older patientseligible for intensive therapy or CPX-351, IDH- or NPM1-mutated AML in unfit patients.
- Is germline (inherited) genetic testing recommended for me or my family?Why: Inherited variants can change treatment and matter for relatives.
Newly diagnosed, unfit for intensive chemotherapy
- For my situation (newly diagnosed, unfit for intensive chemotherapy), which of the standard options do you recommend and why?Why: Guideline options include: Venetoclax plus azacitidine (VIALE-A) or venetoclax plus decitabine; ivosidenib plus azacitidine for IDH1-mutated disease; targeted triplets in trials.
- Am I a candidate for Venetoclax, Azacitidine, Decitabine or related drugs, and what side effects should I expect?Why: Knowing the expected toxicities helps you plan work, family, and supportive care.
- How do the results of VIALE-A and AGILE apply to someone like me?Why: Trial populations differ from individual patients; ask how closely you match.
Fit older patients, 60 to 75
- For my situation (fit older patients, 60 to 75), which of the standard options do you recommend and why?Why: Guideline options include: 7+3 or CPX-351 for secondary disease, with a FLT3 inhibitor where indicated, and reduced-intensity allogeneic transplant in remission.
- Am I a candidate for Cytarabine + anthracycline ('7+3'), CPX-351 (liposomal daunorubicin-cytarabine), Midostaurin or related drugs, and what side effects should I expect?Why: Knowing the expected toxicities helps you plan work, family, and supportive care.
Not a candidate for any leukaemia-directed therapy
- For my situation (not a candidate for any leukaemia-directed therapy), which of the standard options do you recommend and why?Why: Guideline options include: Hydroxyurea for count control, transfusion support and palliative care; low-dose cytarabine or glasdegib combinations where tolerated.
- Am I a candidate for Hydroxyurea (hydroxycarbamide), Glasdegib, Cytarabine, and what side effects should I expect?Why: Knowing the expected toxicities helps you plan work, family, and supportive care.
Relapse after venetoclax-azacitidine
- For my situation (relapse after venetoclax-azacitidine), which of the standard options do you recommend and why?Why: Guideline options include: Genotype-directed drugs (gilteritinib, IDH inhibitors, menin inhibitors) or trials; transplant for the few who respond.
- Am I a candidate for Gilteritinib, Ivosidenib, Revumenib, and what side effects should I expect?Why: Knowing the expected toxicities helps you plan work, family, and supportive care.
Any stage
- Are there clinical trials I could join, for example of Venetoclax, Shorter venetoclax courses in unfit AML, myeloMATCH, G8 geriatric screening tool?Why: Trials are how the next standard of care is set; asking early keeps options open.
- Would a second opinion at a high-volume centre change anything, and can you help arrange it?Why: Rare or high-stakes decisions benefit from a centre that treats many similar patients.
- What supportive care (symptom control, nutrition, exercise, mental health, financial help) is available from the start?Why: Supportive care improves quality of life and helps patients complete treatment.
- I read that “How long venetoclax needs to be given, and whether MRD-negative patients can stop”. How does that affect my plan?Why: Open problems are where trials and second opinions matter most.
- I read that “Whether fit older patients do better with venetoclax-azacitidine than with intensive chemotherapy”. How does that affect my plan?Why: Open problems are where trials and second opinions matter most.
Newly diagnosed? Read the first 60 days with Acute myeloid leukaemia in older or unfit patients, then print the one-page appointment sheet with room for the answers.
Print this page for your appointment (your browser's print command). These prompts are for discussion; your clinical team knows your case.
Direct links plus the targets, companies, and technologies of this cancer's products.
technologies
10targets
6drugs
13companies
11pathways
1terms
3trials
3pairings
1ideas
1Latest papers
topQuery for this cancer: (TITLE:"Acute myeloid leukaemia in older or unfit patients" OR ABSTRACT:"Acute myeloid leukaemia in older or unfit patients" OR TITLE:"Unfit AML" OR ABSTRACT:"Unfit AML" OR TITLE:"AML in the elderly" OR ABSTRACT:"AML in the elderly" OR TITLE:"AML ineligible for intensive chemotherapy" OR ABSTRACT:"AML ineligible for intensive chemotherapy" OR TITLE:"Low-intensity AML therapy" OR ABSTRACT:"Low-intensity AML therapy") AND (treatment OR therapy OR trial OR survival OR diagnosis). Results are unfiltered search hits about Acute myeloid leukaemia in older or unfit patients, not a curated reading list.
Similar pages
not linked directly; found by shared links- CancerSecondary and therapy-related acute myeloid leukaemia
Shares CPX-351 (liposomal daunorubicin-cytarabine), Hypomethylating agents (azacitidine, decitabine), Decitabine, VIALE-A and the tag subtype-page.
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- CancerChronic myeloid leukaemia, accelerated and blast phase
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- CancerChronic lymphocytic leukaemia, first treatment
Shares BCL-2 inhibitors, Tumour lysis syndrome (TLS), Intrinsic apoptosis (BCL-2 family), BCL-2 and the tag subtype-page.