A multicentre phase III clinical trial of dual-epigenetic therapy plus CHOP compared with CHOP in previously untreated patients with peripheral T-cell lymphoma.
10 affiliations
- 1Department of Hematology, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing, China.
- 2Department of Hematology, Shanxi Cancer Hospital, Taiyuan, Shanxi, China.
- 3Department of Hematology, The Second Hospital Of Dalian Medical University, Dalian, China.
- 4Department of Hematology, Central Hospital of Dalian University of Technology, Dalian, China.
- 5Department of Lymphoma and head & neck medical Oncology, Fujian Cancer Hospital, Fujian, China.
- 6Department of Hematology, Jingzhou Hospital Affiliated to Yangtze University, Jingzhou, China.
- 7Department of Hematology, Sheng Jing Hospital of China Medical University, Shenyang, China.
- 8Department of Hematology, Sun Yat-sen University Cancer Center, Guangzhou, China.
- 9Department of Hematology, Beijing Friendship Hospital, Beijing, China.
- 10Department of Hematology, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing, China. [email protected].
Abstract
This phase 3 multicenter trial evaluated the efficacy and safety of adding dual epigenetic agents azacitidine and chidamide to CHOP (AC-CHOP) versus CHOP alone in previously untreated peripheral T-cell lymphoma (PTCL). A total of 128 patients were enrolled from 9 centers in China and assigned according to participating centers (AC-CHOP, N = 84; CHOP, N = 44). Azacitidine 200 mg on days 1-2, 100 mg on day 3 and chidamide 20 mg twice weekly were administered in the AC-CHOP arm. The AC-CHOP arm showed numerically higher ORR (60.7% vs. 54.6%) and CR rate (47.6% vs. 36.4%) than the CHOP arm, although the differences were not statistically significant. A trend toward improved PFS was observed in the AC-CHOP arm (median 10.2 months in the AC-CHOP arm vs. 8.4 months in the CHOP arm, P = 0.093), alongside a significantly improved OS (median 46.2 months vs. 24.1 months, P = 0.023). The safety profile was comparable between the two groups, with hematologic toxicity and infection being the most common adverse events. Genomic profiling showed that DNMT3A mutations were associated with lower response rates, while IDH2 and TP53 mutations were associated with inferior survival outcomes. In conclusion, the addition of chidamide and azacitidine to CHOP did not significantly improve ORR or PFS. Although OS was longer in the AC-CHOP arm, this finding should be interpreted cautiously given the imbalances in post-protocol treatments between the two arms. Integration of molecular profiling may improve risk stratification and inform future biomarker-driven therapeutic strategies in PTCL.
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BibTeX
@article{wei2026multicentre,
title = {{A multicentre phase III clinical trial of dual-epigenetic therapy plus CHOP compared with CHOP in previously untreated patients with peripheral T-cell lymphoma.}},
author = {Chong Wei and Liping Su and Xiaobo Wang and Yang Song and Ningbin Chen and Yuanyan Tang and Aijun Liao and Wei Yang and Zhiming Li and Jing Shen and Daobin Zhou and Wei Zhang},
journal = {Blood cancer journal},
year = {2026},
month = jul,
doi = {10.1038/s41408-026-01570-3},
url = {https://europepmc.org/article/MED/42901914},
note = {CC BY-NC-ND},
}
RIS
TY - JOUR
TI - A multicentre phase III clinical trial of dual-epigenetic therapy plus CHOP compared with CHOP in previously untreated patients with peripheral T-cell lymphoma.
AU - Chong Wei
AU - Liping Su
AU - Xiaobo Wang
AU - Yang Song
AU - Ningbin Chen
AU - Yuanyan Tang
AU - Aijun Liao
AU - Wei Yang
AU - Zhiming Li
AU - Jing Shen
AU - Daobin Zhou
AU - Wei Zhang
PY - 2026
DA - 2026/07/01
JO - Blood cancer journal
DO - 10.1038/s41408-026-01570-3
UR - https://europepmc.org/article/MED/42901914
AB - This phase 3 multicenter trial evaluated the efficacy and safety of adding dual epigenetic agents azacitidine and chidamide to CHOP (AC-CHOP) versus CHOP alone in previously untreated peripheral T-cell lymphoma (PTCL). A total of 128 patients were enrolled from 9 centers in China and assigned according to participating centers (AC-CHOP, N = 84; CHOP, N = 44). Azacitidine 200 mg on days 1-2, 100 mg on day 3 and chidamide 20 mg twice weekly were administered in the AC-CHOP arm. The AC-CHOP arm showed numerically higher ORR (60.7% vs. 54.6%) and CR rate (47.6% vs. 36.4%) than the CHOP arm, although the differences were not statistically significant. A trend toward improved PFS was observed in the AC-CHOP arm (median 10.2 months in the AC-CHOP arm vs. 8.4 months in the CHOP arm, P = 0.093), alongside a significantly improved OS (median 46.2 months vs. 24.1 months, P = 0.023). The safety profile was comparable between the two groups, with hematologic toxicity and infection being the most common adverse events. Genomic profiling showed that DNMT3A mutations were associated with lower response rates, while IDH2 and TP53 mutations were associated with inferior survival outcomes. In conclusion, the addition of chidamide and azacitidine to CHOP did not significantly improve ORR or PFS. Although OS was longer in the AC-CHOP arm, this finding should be interpreted cautiously given the imbalances in post-protocol treatments between the two arms. Integration of molecular profiling may improve risk stratification and inform future biomarker-driven therapeutic strategies in PTCL.
SN - 2044-5385
ER -