Treatment regimen

Azacitidine with venetoclax in AML

Patients aged 75 and over or unfit for intensive chemotherapy (VIALE-A)

Updated: 28 October 20261 min read3 references

Summary for doctors

  • Newly diagnosed AML at age 75 and over or with coexisting conditions [1].
  • Venetoclax ramp-up 100, 200, 400 mg over the first 3 days [1].
  • White cell count below 25,000 before starting (hydroxyurea).
  • With azoles, the venetoclax dose must be reduced.

Dose and schedule

Aza/Ven

AML, unfit for intensive treatmentEach drug’s schedule in the table

AML, unfit for intensive treatment

DrugDoseRouteSchedule
Azacitidine75 mg/m²Subcutaneous or IVDays 1 to 7
Venetoclax100 mg on day 1, 200 on day 2, then 400 mgOral, with foodDays 1 to 28 (continuous)
Cycle schedule
Every 28 days
Duration
Until progression

As in VIALE-A [1]. With posaconazole, venetoclax 70 mg; with voriconazole 100 mg.

Dose source: [2, 3].

Evidence: VIALE-A (2020)

Doses follow the trial protocol, guideline or official drug label (source given in the notes of each regimen). Before prescribing, check blood counts, renal and hepatic function, drug interactions and the patient’s condition, and adjust the dose according to the drug label.

Premedication and supportive care

  • Tumour lysis prevention in cycle 1: hydration, allopurinol, blood tests before each dose increase and 6 to 8 hours afterwards.
  • Antifungal (with venetoclax dose adjustment) and antiviral prophylaxis.

Monitoring and dose adjustment

  • Bone marrow at the end of cycle 1 (around day 21 to 28): if blasts are below 5% and counts are low, hold venetoclax until recovery and shorten it in later cycles (for example 21 or 14 days).
  • Febrile neutropenia is common; G-CSF in complete remission with prolonged neutropenia.

Main evidence

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VIALE-A: median survival 14.7 vs 9.6 months with azacitidine alone; complete remission or complete remission with incomplete count recovery 66.4% vs 28.3% [1].

Related cancer types

References

3 references
Show all references, 1 with a study cardClose the reference list

Numbers in the text, such as [1], refer to these sources. Sources with a “Study card” button are summarised in the site’s evidence library.

  1. 1
    Azacitidine and Venetoclax in Previously Untreated Acute Myeloid LeukemiaDiNardo CD, Jonas BA, Pullarkat V, et al · N Engl J Med · 2020;383:617-629
    Study cardDOIPubMed Back to text: 1 2 3 4
  2. 2
    VENCLEXTA (VENETOCLAX) — Prescribing InformationAbbvie Inc · FDA label · 2026
  3. 3
    VIDAZA (AZACITIDINE) — Prescribing InformationCelgene Corporation · FDA label · 2026

This page is based on reputable scientific sources and was last updated on 28 October 2026. The content of this website is for educational and informational purposes only and does not replace consultation, diagnosis or treatment by a specialist physician. Consult your treating physician about any treatment decision.