Trial reportJapanese journal of clinical oncology2022
Venetoclax plus azacitidine in Japanese patients with untreated acute myeloid leukemia ineligible for intensive chemotherapy.
Trial report in Japanese journal of clinical oncology, 2022. 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 trial NCT02993523 (A Randomized, Double-Blind, Placebo Controlled Phase 3 Study of Venetoclax in Combination With Azacitidine Versus Azacitidine in Treatment Naïve Subjects With Acute Myeloid Leukemia Who Are Ineligible for Standard Induction Therapy), which is not on this map. Cited by 17 papers, 3 of them syntheses that pooled it.
What it found
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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 in Combination With Azacitidine Versus Azacitidine in Treatment Naïve Subjects With Acute Myeloid Leukemia Who Are Ineligible for Standard Induction Therapy
Who cites it
17 citing papers in PubMed, 3 syntheses or guidelines pooled it, 30 citations in OpenAlex.
- Comparative efficacy of venetoclax and hypomethylating agents in acute myeloid leukemia treatment: a meta-analysis of clinical trials and Real-World outcomes.Annals of hematology · 2025Pooled it
- Comparative efficacy and safety in low-intensity treatment for acute myeloid leukemia in older patients: a systematic review and network meta-analysis.European journal of medical research · 2025Pooled it
- Venetoclax adverse event monitoring: a safety meta-analysis of randomized controlled trials and a retrospective evaluation of the FAERS.Annals of hematology · 2024Pooled it
- Real-life multicenter experience of long-term treatment with venetoclax plus azacitidine for acute myeloid leukemia in China.Scientific reports · 2026Article
- A narrative review of mutant isocitrate dehydrogenase AML in Japan based on experience with ivosidenib in AGILE.International journal of hematology · 2026Review
- Efficacy and safety of venetoclax-based regimens versus intensive chemotherapy in older adults with newly diagnosed acute myeloid leukemia: a single-center retrospective study.International journal of hematology · 2026Article
- Real-world outcomes of venetoclax and azacitidine in Japanese patients with newly diagnosed acute myeloid leukemia (VENUS study).International journal of hematology · 2026Article
- Impact of myelodysplasia-related gene mutations and residual mutations at remission in venetoclax/azacitidine for AML.Leukemia · 2025Article
- 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
- Hypomethylating agent versus venetoclax combination: an electronic health records-based target trial emulation among Asian elderly patients with newly diagnosed acute myeloid leukaemia in Hong Kong.Therapeutic advances in hematology · 2025Article
- Exposure-response analyses of venetoclax combined with hypomethylating agents in myelodysplastic syndromes: a retrospective study.Frontiers in pharmacology · 2025Article
- Clinical management of patients diagnosed with acute myeloid leukemia treated with venetoclax in combination with hypomethylating agents after achieving a response: a real-life study.Annals of hematology · 2024Article
- Overexposure to venetoclax is associated with prolonged-duration of neutropenia during venetoclax and azacitidine therapy in Japanese patients with acute myeloid leukemia.Cancer chemotherapy and pharmacology · 2024Observational
- Meta‑analysis of the efficacy of venetoclax and azacitidine combination therapy and azacitidine monotherapy for treating acute myeloid leukemia.Experimental and therapeutic medicine · 2024Article
- Venetoclax: A New Partner in the Novel Treatment Era for Acute Myeloid Leukemia and Myelodysplastic Syndrome.Clinical hematology international · 2023Review
- High susceptibility of febrile neutropenia in Japanese patients receiving venetoclax plus azacitidine therapy for acute myeloid leukemia.Annals of hematology · 2023Article
- Utility of therapeutic drug monitoring of venetoclax in acute myeloid leukemia.Medical oncology (Northwood, London, England) · 2022Article
Corrections and comments
- Erratum issued
Authors and funding
23 authors at 19 institutions in 2 countries.
Funding
Abstract
backgroundThe phase 3 VIALE-A trial (NCT02993523) reported that venetoclax-azacitidine significantly prolonged overall survival compared with placebo-azacitidine in patients with newly diagnosed acute myeloid leukemia ineligible for intensive chemotherapy. Herein, efficacy and safety of venetoclax-azacitidine are analyzed in the Japanese subgroup of VIALE-A patients.
methodsEligible Japanese patients were randomized 2:1 to venetoclax-azacitidine (N = 24) or placebo-azacitidine (N = 13). Primary endpoints for Japan were overall survival and complete response (CR) + CR with incomplete hematologic recovery (CRi). Venetoclax (target dose 400 mg) was given orally once daily. Azacitidine (75 mg/m2) was administered subcutaneously or intravenously on Days 1-7 of each 28-day cycle.
resultsMedian follow-up was 16.3 months (range, 1.0-20.3). Median overall survival was not reached with venetoclax-azacitidine (hazard ratio 0.409 and 95% confidence interval: 0.151, 1.109); overall survival estimate was higher with venetoclax-azacitidine than placebo-azacitidine at 12 (67 and 46%) and 18 months (57 and 31%), respectively. CR and CRi rates were 67% with venetoclax-azacitidine and 15% with placebo-azacitidine. Most common any-grade adverse events were febrile neutropenia (79 and 39%), thrombocytopenia (54 and 77%), constipation (54 and 54%) and decreased appetite (54 and 38%) in the venetoclax-azacitidine and placebo-azacitidine arms, respectively. Only 1 patient in the venetoclax-azacitidine arm, and no patients in the placebo-azacitidine arm, had grade 4 febrile neutropenia that led to treatment discontinuation.
conclusionsThis Japanese subgroup analysis of VIALE-A demonstrates comparable safety and efficacy outcomes compared with the global study and supports venetoclax-azacitidine as first-line standard-of-care for Japanese treatment-naive patients with acute myeloid leukemia who are ineligible for intensive chemotherapy.
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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.