ArticleBlood neoplasia2025
The oral CDK9 inhibitor voruciclib combined with venetoclax for patients with relapsed/refractory acute myeloid leukemia.
Article in Blood neoplasia, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03547115 (Phase 1, Open-label, Study of Voruciclib in Subjects With Relapsed and/or Refractory B Cell Malignancies or AML After Failure of Prior Standard Therapies and Voruciclib in Combination With Venetoclax in Subjects With Relapsed/Refractory AML), which is not on this map. Cited by 3 papers.
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.
Phase 1, Open-label, Study of Voruciclib in Subjects With Relapsed and/or Refractory B Cell Malignancies or AML After Failure of Prior Standard Therapies and Voruciclib in Combination With Venetoclax in Subjects With Relapsed/Refractory AML
Who cites it
3 citing papers in PubMed.
- CDK9 and hematologic malignancies: pioneering novel therapeutic approaches.Clinical and experimental medicine · 2026Review
- Review
- Acute myeloid leukemia drug resistance: targetable nodes and the clinical trajectory of small-molecule inhibitors.Frontiers in pharmacology · 2025Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
14 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
The antiapoptotic protein myeloid cell leukemia 1 (Mcl-1) promotes cell survival in acute myeloid leukemia (AML), and its overexpression is associated with resistance to venetoclax. Voruciclib, an oral cyclin-dependent kinase 9 inhibitor, indirectly decreases Mcl-1 protein expression and has synergistic activity with venetoclax in AML preclinical models. We hypothesized that voruciclib in combination with venetoclax would induce responses in patients with AML with disease progression after venetoclax therapy. This dose-escalation study evaluated voruciclib administered on days 1 to 14 of 28-day cycles with venetoclax daily. The study enrolled 41 adult patients with AML after failure of previous standard therapies. Patients had a median of 2 (range, 1-7) previous lines of therapy, 19 patients (46%) had ≥3 previous lines of therapy, and 39 (95%) had previous venetoclax. No dose-limiting toxicities were reported in 7 dose levels evaluated. The most common adverse events were nausea (34%), febrile neutropenia (32%), diarrhea (22%), dyspnea (22%), hypokalemia (22%), and thrombocytopenia (22%). Antileukemic activity was observed in 10 (24%) patients, including 3 with complete marrow remission and 7 with stable disease lasting ≥3 months. We observed a rebound of circulating blasts during the 14 days of single-agent venetoclax dosing in 40% of evaluable patients. Mcl-1 protein expression and RNA polymerase II Ser-2 phosphorylation decreased on voruciclib. Overall, the combination of voruciclib with venetoclax was tolerable in patients with relapsed/refractory AML, had antileukemic activity, and showed on-target effects in heavily pretreated patients with disease progression after venetoclax. This trial was registered at www.ClinicalTrials.gov as #NCT03547115.
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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.