{"entity":{"id":"idea-shortened-venetoclax","kind":"idea","name":"Shorter venetoclax courses in unfit AML","aka":[],"tldr":"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.","asOf":"2026-09-07","links":[{"label":"VIALE-A: azacitidine and venetoclax in previously untreated acute myeloid leukaemia (NEJM 2020)","url":"https://doi.org/10.1056/NEJMoa2012971"}],"tags":[],"related":[],"cancers":["aml"],"sections":[],"technologies":[],"targets":[],"drugs":["venetoclax","azacitidine","decitabine-cedazuridine"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":["viale-a"],"people":[],"bottlenecks":[],"keyPapers":["paper-viale-a-venetoclax-azacitidine-nejm-2020","paper-aza-aml-001-dombret-blood-2015","paper-azacitidine-aml-j-clin-oncol-2010"],"journals":[],"dependsOn":[],"notes":[],"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.","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"},"route":"/ideas/idea-shortened-venetoclax/","neighbours":{"cancer":[{"id":"aml","kind":"cancer","name":"Acute myeloid leukaemia","route":"/cancers/aml/"},{"id":"aml-older-unfit","kind":"cancer","name":"Acute myeloid leukaemia in older or unfit patients","route":"/cancers/aml-older-unfit/"}],"drug":[{"id":"azacitidine","kind":"drug","name":"Azacitidine","route":"/drugs/azacitidine/"},{"id":"decitabine-cedazuridine","kind":"drug","name":"Decitabine + cedazuridine (oral)","route":"/drugs/decitabine-cedazuridine/"},{"id":"venetoclax","kind":"drug","name":"Venetoclax","route":"/drugs/venetoclax/"}],"trial":[{"id":"viale-a","kind":"trial","name":"VIALE-A","route":"/trials/viale-a/"}],"paper":[{"id":"paper-aza-aml-001-dombret-blood-2015","kind":"paper","name":"AZA-AML-001: azacitidine versus conventional care in older patients with acute myeloid leukaemia and more than 30 percent blasts","route":"/key-papers/paper-aza-aml-001-dombret-blood-2015/"},{"id":"paper-azacitidine-aml-j-clin-oncol-2010","kind":"paper","name":"Azacitidine prolongs overall survival compared with conventional care regimens in elderly patients with low bone marrow blast count acute myeloid leukemia","route":"/key-papers/paper-azacitidine-aml-j-clin-oncol-2010/"},{"id":"paper-viale-a-venetoclax-azacitidine-nejm-2020","kind":"paper","name":"VIALE-A: venetoclax plus azacitidine for older adults with acute myeloid leukaemia who cannot have intensive chemotherapy","route":"/key-papers/paper-viale-a-venetoclax-azacitidine-nejm-2020/"}],"bottleneck":[{"id":"b-aging-comorbidity","kind":"bottleneck","name":"Older and multimorbid patients are excluded and undertreated","route":"/bottlenecks/b-aging-comorbidity/"},{"id":"b-dose-optimisation","kind":"bottleneck","name":"Wrong doses","route":"/bottlenecks/b-dose-optimisation/"}]}}