AUTHOR=Yin Jia , Wan Chao-Ling , Zhang Ling , Zhang Hao , Bai Lian , Zhou Hai-Xia , Xu Ming-Zhu , Chen Li-Yun , Qian Chong-Sheng , Qiu Hui-Ying , Chen Su-Ning , Tang Xiao-Wen , Wu De-Pei , Zhang Yan-Ming , Sun Ai-Ning , Xue Sheng-Li 

TITLE=A Phase II Trial of the Double Epigenetic Priming Regimen Including Chidamide and Decitabine for Relapsed/Refractory Acute Myeloid Leukemia

JOURNAL=Frontiers in Oncology

VOLUME=11

YEAR=2021

URL=https://www.frontiersin.org/journals/oncology/articles/10.3389/fonc.2021.726926

DOI=10.3389/fonc.2021.726926

ISSN=2234-943X

ABSTRACT=<sec><title>Objective</title><p>To explore the role of chidamide, decitabine plus priming regimen in the salvage treatment of relapsed/refractory acute myeloid leukemia.</p></sec><sec><title>Methods</title><p>A clinical trial was conducted in relapsed/refractory acute myeloid leukemia patients using chidamide, decitabine, cytarabine, idarubicin, and granulocyte-colony stimulating factor, termed CDIAG, a double epigenetic priming regimen.</p></sec><sec><title>Results</title><p>Thirty-five patients were recruited. Three patients received 2 treatment cycles. In 32 evaluable patients and 35 treatment courses, the completed remission rate (CRR) was 42.9%. The median OS time was 11.7 months. The median OS times of responders were 18.4 months, while those of nonresponders were 7.4 months (P = 0.015). The presence of RUNX1 mutations was associated with a high CRR but a short 2-year OS (P = 0.023) and PFS (P = 0.018) due to relapse after treatment. The presence of IDH mutations had no effect on the remission rate (80.0% <italic>vs</italic>. 73.3%), but showed a better OS (2-year OS rate: 100.0% <italic>vs</italic>. 28.9%). Grade 3/4 nonhematological adverse events included pneumonia, hematosepsis, febrile neutropenia, skin and soft tissue infection and others.</p></sec><sec><title>Conclusion</title><p>The double epigenetic priming regimen (CDIAG regimen) showed considerably good antileukemia activity in these patients. Adverse events were acceptable according to previous experience. The study was registered as a clinical trial.</p></sec><sec><title>Clinical Trial Registration</title><p><uri xlink:href="https://clinicaltrials.gov/" xmlns:xlink="http://www.w3.org/1999/xlink">https://clinicaltrials.gov/</uri>, identifier:NCT03985007</p></sec>