ArticleFrontiers in immunology2025
Phase 1 study of chidamide in combination with venetoclax, azacitidine, aclarubicin, cytarabine and G-CSF for refractory/relapsed acute myeloid leukemia: clinical safety, efficacy, and correlative analysis.
Article in Frontiers in immunology, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.
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1 citing paper in PubMed.
- Genome Agnostic Reprogramming of Acute Myelocytic Leukemia Hallmarks by Targeting Non-Oncogene Addictions with Azacitidine Plus Pioglitazone and All-Trans Retinoic Acid.International journal of molecular sciences · 2026Review
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11 authors.
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Abstract
Background: Relapsed or refractory AML (R/R-AML) remains a particularly adverse population necessitating improved therapeutic strategies. In this phase 1 study, we evaluated the efficacy and safety of chidamide, azacitidine, cytarabine, aclarubicin and granulocyte colony-stimulating factor (CACAG) in combination with the B cell lymphoma-2 inhibitor venetoclax (VEN) in R/R-AML. Methods: We conducted a phase 1 trial to assess the safety and efficacy of CACAG-VEN regimen as a salvage induction regimen for patients with R/R AML. The primary endpoint was the treatment-related adverse events and overall response rate (ORR) following one cycle of the CACAG-VEN regimen. We also performed single-cell RNA sequencing on eight samples of bone marrow from four patients before and after CACAG-VEN treatment. Results: From January 10, 2022, to June 8, 2024, the median follow-up was 461 days (range: 180-985 days). Thirty-four patients with refractory (n = 17) and relapsed (n = 17) AML were enrolled. The ORR was 76.5%, and the complete response rate was 73.5%. In patients with composite complete response (CRc), 44% of patients attained a measurable residual disease negative status, the 1-year overall survival (OS) rate was 82.3% (95% CI: 67.8-99.9%) and the progression-free survival rate (PFS) was 79.8%. After one cycle of CACAG-VEN, 44.1% (n = 15) of patients developed grade 3-4 myelosuppression. The median durations of neutropenia and thrombocytopenia were 17 days (95% CI: 15-22 days) and 24 days (95% CI: 22-41 days), respectively. Single-cell RNA sequencing revealed that post-treatment downregulation of MCL1, HIF1A, and ABCC1, highlighting the multi-targeted action of the regimen. Furthermore, treatment response was associated with the suppression of mitochondrial activity and the activation of the p53 signaling pathway. Conclusion: In patients with R/R AML, the CACAG-VEN regimen resulted in significant clinical benefits, with a high CRc rate and encouraging survival, as well as being well tolerated. Clinical Trial Registration: https://www.chictr.org.cn/, identifier, ChiCTR2200065634.
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