# Shorter venetoclax courses in unfit AML

Source: https://onco.cc/ideas/idea-shortened-venetoclax/  
OnCo record `idea-shortened-venetoclax` (Idea). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

Give venetoclax for 7 or 14 days per cycle instead of 28 to cut infections and low blood counts without losing the benefit.

## Summary

The idea is to give venetoclax for 7 or 14 days per 28-day cycle, rather than continuously, when combined with azacitidine or oral decitabine-cedazuridine in acute myeloid leukaemia patients unfit for intensive chemotherapy. Cytopenias and infections are the main cause of early death on venetoclax-azacitidine, marrow blasts clear within two weeks, and continued exposure mainly suppresses normal blood cell production. Retrospective and small prospective series show similar remission rates with shorter courses, against the 28-day schedule of VIALE-A. The hypothesis is that 14 days per cycle is non-inferior for overall survival with less severe infection; the test is a randomised non-inferiority trial, addressing the wrong-doses and older-patient bottlenecks.

## Fields

- Kind: Idea
- Last checked: 2026-09-07
- Hypothesis: Venetoclax 14 days per 28-day cycle after cycle 1 is non-inferior to 28 days for OS in unfit AML and reduces grade 3+ infection.
- Rationale: Marrow blasts clear within the first two weeks; continued exposure mainly suppresses normal haematopoiesis.
- Proposed test: Randomised non-inferiority trial of 14- vs 28-day venetoclax with azacitidine (or oral decitabine-cedazuridine); co-primary OS and febrile neutropenia.
- Maturity: early-clinical

## Sources

- VIALE-A: azacitidine and venetoclax in previously untreated acute myeloid leukaemia (NEJM 2020): https://doi.org/10.1056/NEJMoa2012971

## Connected records

- cancers: [Acute myeloid leukaemia](https://onco.cc/cancers/aml/), [Acute myeloid leukaemia in older or unfit patients](https://onco.cc/cancers/aml-older-unfit/)
- drugs: [Azacitidine](https://onco.cc/drugs/azacitidine/), [Decitabine + cedazuridine (oral)](https://onco.cc/drugs/decitabine-cedazuridine/), [Venetoclax](https://onco.cc/drugs/venetoclax/)
- trials: [VIALE-A](https://onco.cc/trials/viale-a/)
- key papers: [AZA-AML-001: azacitidine versus conventional care in older patients with acute myeloid leukaemia and more than 30 percent blasts](https://onco.cc/key-papers/paper-aza-aml-001-dombret-blood-2015/), [Azacitidine prolongs overall survival compared with conventional care regimens in elderly patients with low bone marrow blast count acute myeloid leukemia](https://onco.cc/key-papers/paper-azacitidine-aml-j-clin-oncol-2010/), [VIALE-A: venetoclax plus azacitidine for older adults with acute myeloid leukaemia who cannot have intensive chemotherapy](https://onco.cc/key-papers/paper-viale-a-venetoclax-azacitidine-nejm-2020/)
- bottlenecks: [Older and multimorbid patients are excluded and undertreated](https://onco.cc/bottlenecks/b-aging-comorbidity/), [Wrong doses](https://onco.cc/bottlenecks/b-dose-optimisation/)

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