Trial reportBlood cancer journal2021
6-month follow-up of VIALE-C demonstrates improved and durable efficacy in patients with untreated AML ineligible for intensive chemotherapy (141/150).
Trial report in Blood cancer journal, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. It is linked to 2 registered trials, which are not on this map. Cited by 23 papers, 2 of them syntheses that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
A Randomized, Double-Blind, Placebo Controlled Phase 3 Study of Venetoclax Co-Administered With Low Dose Cytarabine Versus Low Dose Cytarabine in Treatment Naïve Patients With Acute Myeloid Leukemia Who Are Ineligible for Intensive Chemotherapy
A Phase 1/2 Multicenter Open-label Study to Investigate Treatment of Hydroxyurea in Combination With Valproic Acid (VPA), or 6- Mercaptopurine in Combination With VPA in Patients With AML or HR-MDS Unfit for Standard Therapy
Who cites it
23 citing papers in PubMed, 2 syntheses or guidelines pooled it.
- Indirect treatment comparison of ivosidenib and other therapies in patients with newly diagnosed acute myeloid leukemia.Future oncology (London, England) · 2025Pooled it
- Venetoclax combined chemotherapy versus chemotherapy alone for acute myeloid leukemia: a systematic review and meta-analysis.Frontiers in oncology · 2024Pooled it
- Safety run-in and part 1 of GIMEMA AML1718: venetoclax combined with FLAI as induction treatment in non-low-risk AML.Blood advances · 2025Trial
- Venetoclax plus low-dose cytarabine in patients with newly diagnosed acute myeloid leukemia ineligible for intensive chemotherapy: an expanded access study in Japan.Japanese journal of clinical oncology · 2023Trial
- Intensive Induction in AML in the Era of Venetoclax: A Standing Count for "7 + 3"?American journal of hematology · 2026Article
- Management of Acute Myeloid Leukemia in Older Patients: An Updated Canadian Consensus.Current oncology (Toronto, Ont.) · 2026Article
- Diagnosis-Driven Targeted Therapy in Acute Myeloid Leukemia: Clinical Integration of Tyrosine Kinase, BCL-2, and CD33-Directed Strategies with Midostaurin, Venetoclax, and Gemtuzumab Ozogamicin.Journal of clinical medicine · 2026Review
- Novel treatment strategies in acute myeloid leukemia.Blood research · 2026Review
- Risk stratification of low-dose cytarabine and venetoclax in patients with AML ineligible for intensive chemotherapy.Blood advances · 2026Article
- Acute Myeloid Leukemia: 2025 Update on Diagnosis, Risk-Stratification, and Management.American journal of hematology · 2025Review
- Treatment outcomes and safety of reduced‑dose venetoclax plus antifungal agents to treat acute myeloid leukemia: A single hospital experience in Taiwan.Oncology letters · 2025Article
- Psychiatric and substance use disorders predict poor outcomes in older veterans with acute myeloid leukemia.Blood advances · 2025Article
- Diverse real-life outcomes after intensive risk-adapted therapy for 1034 AML patients from the CETLAM Group.Blood cancer journal · 2025Article
- Remission rate, toxicity and pharmacokinetics of venetoclax-based induction regimens in untreated pediatric acute myeloid leukemia.NPJ precision oncology · 2024Article
- Venetoclax-Related Neutropenia in Leukemic Patients: A Comprehensive Review of the Underlying Causes, Risk Factors, and Management.Pharmaceuticals (Basel, Switzerland) · 2024Review
- Dismal outcome of refractory or relapsing patients with myelodysplasia-related acute myeloid leukemia partially alleviated by intensive chemotherapy.Cancer medicine · 2024Article
- BCL2 Inhibition: A New Paradigm for the Treatment of AML and Beyond.HemaSphere · 2023Review
- Venetoclax: A New Partner in the Novel Treatment Era for Acute Myeloid Leukemia and Myelodysplastic Syndrome.Clinical hematology international · 2023Review
- Recent advances in targeted therapies in acute myeloid leukemia.Journal of hematology & oncology · 2023Review
- Small molecule inhibitors targeting the cancers.MedComm · 2022Review
Corrections and comments
- Erratum issued
Authors and funding
24 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
VIALE-C compared the safety and efficacy of venetoclax or placebo plus low-dose cytarabine (+LDAC) in patients with untreated AML ineligible for intensive chemotherapy. Overall, 211 patients were enrolled (n = 143, venetoclax; n = 68, placebo). At the primary analysis, the study did not meet its primary endpoint of a statistically significant improvement in overall survival (OS), however, ~60% of patients had been on study for ≤6-months. Here, we present an additional 6-months of follow-up of VIALE-C (median follow-up 17.5 months; range 0.1-23.5). Median OS was (venetoclax +LDAC vs. placebo +LDAC) 8.4 vs. 4.1 months (HR = 0.70, 95% CI 0.50,0.99; P = 0.040); a 30% reduction in the risk of death with venetoclax. Complete response (CR)/CR with incomplete hematologic recovery (CRi) rates were 48.3% vs. 13.2%. Transfusion independence rates (RBC) were 43% vs.19% and median event-free survival was 4.9 vs. 2.1 months (HR = 0.61; 95% CI 0.44,0.84; P = 0.002). These results represent improved efficacy over the primary analysis. Incidence of grade ≥3 adverse events were similar between study arms and overall safety profiles were comparable to the primary analysis. These data support venetoclax +LDAC as a frontline treatment option for patients with AML ineligible for intensive chemotherapy.This trial was registered at www.clinicaltrials.gov as #NCT03069352.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.