Efficacy and safety of mitoxantrone hydrochloride liposome in peripheral T-cell lymphoma: A multicenter, non-interventional, ambispective cohort real-world study

Abstract Background: Peripheral T-cell lymphoma (PTCL) represents a heterogeneous group of aggressive lymphomas, accounting for 25%–30% of non-Hodgkin lymphomas (NHL) in China. The CHOP regimen remains the standard first-line treatment for PTCL, yet its long-term efficacy requires improvement. Relapsed or refractory (R/R) PTCL is highly aggressive with extremely poor survival outcomes, exhibiting a 3-year overall survival (OS) rate of less than 30%. This MOMENT study demonstrated promising efficacy and safety of the mitoxantrone hydrochloride liposome (Lipo-MIT)-based regimen in PTCL (J Leuk Lymphoma, 2023, 32(8): 457-464). Nevertheless, additional data are warranted to establish further validation. We previously reported updated real-world evidence for Lipo-MIT in treatment-naïve (TN) PTCL (2025 EHA, #PF949), showing a complete response (CR) rate of 48.2% and objective response rate (ORR) of 83.6%. Herein, we present updated survival outcomes for Lipo-MIT in TN-PTCL and provide the most recent real-world evidence regarding Lipo-MIT in R/R PTCL. Methods: This multicenter, non-interventional, ambispective cohort real-world study was registered at www.chictr.org.cn (ChiCTR2200062067). It enrolled adult patients diagnosed with TN or R/R PTCL. The primary endpoint was ORR. Secondary endpoints included CR rate, progression-free survival (PFS), OS, and safety. Results: As of February 8, 2025, 609 patients were enrolled, comprising 494 with relapsed/refractory PTCL (R/R PTCL) and 115 with treatment-naïve PTCL (TN-PTCL). The R/R cohort had a median age of 56 years (range: 19–86) with 62.1% males; subtypes included angioimmunoblastic T-cell lymphoma (AITL, 30.0%), extranodal NK/T-cell lymphoma (NKTCL, 25.9%), PTCL not otherwise specified (PTCL-NOS, 24.9%), ALK-negative anaplastic large cell lymphoma (ALCL, ALK-, 5.9%), ALK-positive ALCL (ALCL, ALK+, 2.8%), and other subtypes (10.5%). Advanced-stage (III–IV) disease was present in 67.0% pts, 27.9% had International prognostic index (IPI) scores 3–5, and 21.1% exhibited B symptoms. Prior therapy exposure included: ≥1 lines in all patients (50.4% first-line, 21.3% second-line, 28.3% ≥third-line), with 74.9% previously receiving anthracyclines. Patients received Lipo-MIT-containing regimens for a median of 3 cycles (range: 1–11), with median Lipo-MIT doses of 17.7 mg/m² (monotherapy: range 11.2–20.3 mg/m²; combination: range 5.4–23.3 mg/m²). Among 456 efficacy-evaluable R/R patients, the overall response rate (ORR) was 62.1% (283/456) and complete response (CR) rate was 29.2% (133/456), with ORR varying by subtype: AITL 68.6% (96/140), NKTCL 60.8% (73/120), PTCL-NOS 57.5% (65/113), ALCL ALK- 51.9% (14/27), and ALCL ALK+ 61.5% (8/13). Response rates decreased with prior lines: 68.1% (160/235) after first-line, 61.6% (61/99) after second-line, and 50.8% (62/122) after ≥third-line therapy. With a median follow-up of 6.5 months, median progression-free survival (PFS) was 9.9 months (95% CI: 7.1–12.7) and median overall survival (OS) was not reached. In the TN cohort (n=115), median follow-up was 11.6 months with median PFS of 14.6 months (95% CI: 10.8–18.3); 1-year PFS rates was 58.6%. Median OS was not reached, with 1-year OS rates of 88.0%. Safety analysis of the full cohort (n=609) revealed treatment-related adverse events (TRAEs) in 89.0% (542/609), with grade ≥3 TRAEs in 66.0%. Predominant hematologic toxicities included neutropenia (46.6%), leukopenia (42.2%), lymphopenia (34.5%), anemia (22.5%), and thrombocytopenia (23.0%). Non-hematologic TRAEs were primarily grade 1–2; no unexpected or serious adverse events were observed. Conclusion: Lipo-MIT-based regimens demonstrated favorable clinical efficacy and tolerability in both TN-PTCL and R/R PTCL, representing a promising therapeutic option. Continued follow-up for survival outcomes is ongoing, with additional results forthcoming.

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Journal
Blood
Published
2025-11-03
DOI
https://doi.org/10.1182/blood-2025-1878
Primary Topic
Lymphoma Diagnosis and Treatment
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article
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article

Efficacy and safety of mitoxantrone hydrochloride liposome in peripheral T-cell lymphoma: A multicenter, non-interventional, ambispective cohort real-world study

Zengjun Li, Pengcheng He, Dongping Huang, Kaiyang Ding et al.
Blood
Lymphoma Diagnosis and Treatment
article

Efficacy and safety of mitoxantrone hydrochloride liposome in peripheral T-cell lymphoma: A multicenter, non-interventional, ambispective cohort real-world study

Zengjun Li, Pengcheng He, Dongping Huang, Kaiyang Ding, Jun Fang, Jinhai Ren, Lihong Liu, Ming Jiang, Jun Ma, Xiangxiang Zhou, Dehui Zou, Ganggang Wang, Liqun Zou, Shuangnian Xu, Yanhong Tong, Zunmin Zhu, Kai Hu, Hongfeng Ge, Zhilin Gao, Wuping Li, Lintao Bi, Rong Fu, Xiaojing Xing, Zhixue Zhang, Yunhong Huang, Hongmei Jing, Haihua Fan, Zhimin Yan, Zhenqian Huang, Guangxun Gao, Aichun Liu, Huiqiang Huang, Dengju Li, Fang Wang, Hao Zhang, Qingshan Li, Xiaobo Wang, Xi Zhang, Wei Liu, Liang Wang, Jingbo Wang, Yi Wang, Jun Qian, Liling Zhang, Lee Jia, Jian Ge, Liangquan Geng, Jie Jin, Xiaojing Yan, Dan Luo, Liang Li, Zhiming Li, Wei Yang, Donglu Zhao, Chanjuan Shen, Liping Su, Quande Lin, Yanli Yang, Xiaonan Sun, Xiuhua Sun, Wenbin Qian, Lugui Qiu, Yao Liu, Hui Zhou
article en

Abstract

Abstract Background: Peripheral T-cell lymphoma (PTCL) represents a heterogeneous group of aggressive lymphomas, accounting for 25%–30% of non-Hodgkin lymphomas (NHL) in China. The CHOP regimen remains the standard first-line treatment for PTCL, yet its long-term efficacy requires improvement. Relapsed or refractory (R/R) PTCL is highly aggressive with extremely poor survival outcomes, exhibiting a 3-year overall survival (OS) rate of less than 30%. This MOMENT study demonstrated promising efficacy and safety of the mitoxantrone hydrochloride liposome (Lipo-MIT)-based regimen in PTCL (J Leuk Lymphoma, 2023, 32(8): 457-464). Nevertheless, additional data are warranted to establish further validation. We previously reported updated real-world evidence for Lipo-MIT in treatment-naïve (TN) PTCL (2025 EHA, #PF949), showing a complete response (CR) rate of 48.2% and objective response rate (ORR) of 83.6%. Herein, we present updated survival outcomes for Lipo-MIT in TN-PTCL and provide the most recent real-world evidence regarding Lipo-MIT in R/R PTCL. Methods: This multicenter, non-interventional, ambispective cohort real-world study was registered at www.chictr.org.cn (ChiCTR2200062067). It enrolled adult patients diagnosed with TN or R/R PTCL. The primary endpoint was ORR. Secondary endpoints included CR rate, progression-free survival (PFS), OS, and safety. Results: As of February 8, 2025, 609 patients were enrolled, comprising 494 with relapsed/refractory PTCL (R/R PTCL) and 115 with treatment-naïve PTCL (TN-PTCL). The R/R cohort had a median age of 56 years (range: 19–86) with 62.1% males; subtypes included angioimmunoblastic T-cell lymphoma (AITL, 30.0%), extranodal NK/T-cell lymphoma (NKTCL, 25.9%), PTCL not otherwise specified (PTCL-NOS, 24.9%), ALK-negative anaplastic large cell lymphoma (ALCL, ALK-, 5.9%), ALK-positive ALCL (ALCL, ALK+, 2.8%), and other subtypes (10.5%). Advanced-stage (III–IV) disease was present in 67.0% pts, 27.9% had International prognostic index (IPI) scores 3–5, and 21.1% exhibited B symptoms. Prior therapy exposure included: ≥1 lines in all patients (50.4% first-line, 21.3% second-line, 28.3% ≥third-line), with 74.9% previously receiving anthracyclines. Patients received Lipo-MIT-containing regimens for a median of 3 cycles (range: 1–11), with median Lipo-MIT doses of 17.7 mg/m² (monotherapy: range 11.2–20.3 mg/m²; combination: range 5.4–23.3 mg/m²). Among 456 efficacy-evaluable R/R patients, the overall response rate (ORR) was 62.1% (283/456) and complete response (CR) rate was 29.2% (133/456), with ORR varying by subtype: AITL 68.6% (96/140), NKTCL 60.8% (73/120), PTCL-NOS 57.5% (65/113), ALCL ALK- 51.9% (14/27), and ALCL ALK+ 61.5% (8/13). Response rates decreased with prior lines: 68.1% (160/235) after first-line, 61.6% (61/99) after second-line, and 50.8% (62/122) after ≥third-line therapy. With a median follow-up of 6.5 months, median progression-free survival (PFS) was 9.9 months (95% CI: 7.1–12.7) and median overall survival (OS) was not reached. In the TN cohort (n=115), median follow-up was 11.6 months with median PFS of 14.6 months (95% CI: 10.8–18.3); 1-year PFS rates was 58.6%. Median OS was not reached, with 1-year OS rates of 88.0%. Safety analysis of the full cohort (n=609) revealed treatment-related adverse events (TRAEs) in 89.0% (542/609), with grade ≥3 TRAEs in 66.0%. Predominant hematologic toxicities included neutropenia (46.6%), leukopenia (42.2%), lymphopenia (34.5%), anemia (22.5%), and thrombocytopenia (23.0%). Non-hematologic TRAEs were primarily grade 1–2; no unexpected or serious adverse events were observed. Conclusion: Lipo-MIT-based regimens demonstrated favorable clinical efficacy and tolerability in both TN-PTCL and R/R PTCL, representing a promising therapeutic option. Continued follow-up for survival outcomes is ongoing, with additional results forthcoming.

BloodVol. 146(Supplement 1)
Wannan Medical College (CN), Shangrao Normal University (CN), Hebei Medical University (CN), Jiangsu University (CN), Beijing Tongren Hospital (CN), Union Hospital (HK), Guiyang Medical University (CN), Army Medical University (CN), Harbin Medical University (CN), Sun Yat-sen University (CN), Bengbu Medical College (CN), Shanxi Medical University (CN), Dalian Medical University (CN), Anhui Medical University (CN), Changzhi Medical College (CN), Chinese Academy of Medical Sciences & Peking Union Medical College (CN), Peking University (CN), Harbin Institute of Technology (CN), Sichuan University (CN), Tianjin Medical University General Hospital (CN), West China Hospital of Sichuan University (CN), Shaanxi Provincial People's Hospital (CN), Jiangxi Provincial Cancer Hospital (CN), First Affiliated Hospital of Guangzhou Medical University (CN), Fourth Affiliated Hospital of China Medical University (CN), Second Hospital of Hebei Medical University (CN), Red Cross Hospital (GR), Second Affiliated Hospital of Dalian Medical University (CN), Central People's Hospital of Zhanjiang (CN), Guizhou Cancer Hospital (CN), Third Affiliated Hospital of Harbin Medical University (CN), Fourth Hospital of Hebei Medical University (CN), Tongren Hospital (CN), Aerospace Center Hospital (CN), Beijing Anding Hospital (CN), Gannan Medical University (CN), Bozhou People's Hospital (CN), Hunan Cancer Hospital (CN), Shandong Provincial Hospital (CN), Xinqiao Hospital (CN), First Affiliated Hospital of Xi'an Jiaotong University (CN), Wuhan Union Hospital (CN), Anhui Provincial Hospital (CN), Southwest Hospital (CN), Henan Provincial People's Hospital (CN), First Affiliated Hospital of Gannan Medical University (CN), First Affiliated Hospital of Anhui Medical University (CN), Zhuzhou Central Hospital (CN), First Hospital of China Medical University (CN), First Affiliated Hospital of Dalian Medical University (CN), Peking University Third Hospital (CN), Henan Cancer Hospital (CN), First Bethune Hospital of Jilin University (CN), Zhenjiang City Fourth People's Hospital (CN), Sun Yat-sen University Cancer Center (CN), Institute of Hematology & Blood Diseases Hospital (CN), First Affiliated Hospital of Bengbu Medical College (CN), Qujiang People's Hospital (CN), Chongqing Cancer Hospital (CN), Second Affiliated Hospital of Zhejiang University (CN), Shanxi Academy of Medical Sciences (CN), Xijing Hospital (CN), Tongji Hospital (CN), Shanxi Provincial People’s Hospital (CN), Liaoning Cancer Hospital & Institute (CN), Affiliated Hospital of Jining Medical University (CN), Loudi Central Hospital (CN), Shandong First Medical University (CN), Union Hospital (CN), Yuxian People's Hospital (CN), First Affiliated Hospital Zhejiang University (CN), First Affiliated Hospital of Wannan Medical College (CN), Huazhong University of Science and Technology (CN), China Medical University (CN), Guangzhou Medical University (CN), Air Force Medical University (CN)
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