奇达胺联合阿扎胞苷、米托蒽醌脂体和强的松(camp方案)治疗treatment-naÏve tfh源性外周t细胞淋巴瘤

IF 3.3 4区 医学 Q2 HEMATOLOGY
H. Liu, W. Liu, W. Huang, L. Qiu, D. Zou
{"title":"奇达胺联合阿扎胞苷、米托蒽醌脂体和强的松(camp方案)治疗treatment-naÏve tfh源性外周t细胞淋巴瘤","authors":"H. Liu,&nbsp;W. Liu,&nbsp;W. Huang,&nbsp;L. Qiu,&nbsp;D. Zou","doi":"10.1002/hon.70094_392","DOIUrl":null,"url":null,"abstract":"<p><b>Objective:</b> Peripheral T-cell lymphoma (PTCL) is a rare but challenging malignancy, in which the TFH (T follicular helper)-derived PTCL subtype has a poor prognosis and limited treatment options. In this study, chidamide in combination with azacitidine, mitoxantrone liposomes and prednisone (CAMP regimen) was used for the treatment of treatment-naïve TFH-derived peripheral T-cell lymphoma, aiming to evaluate the efficacy and safety of this treatment regimen and provide a new treatment option for clinical practice.</p><p><b>Methods:</b> This study is a multicenter, prospective phase II clinical trial (clinical trial ID: IIT2023003), the main purpose of which is to investigate the safety and preliminary efficacy (ORR rate) of chidamide in combination with azacitidine, mitoxantrone liposome and prednisone (CAMP regimen) in the treatment of treatment-naïve TFH-derived PTCL. Eligible treatment-naïve TFH-derived PTCL patients were included in the program who received CAMP regimen combination therapy, the specific regimen was: chidamide 30 mg/day orally, biw; azacitidine 75 mg/m<sup>2</sup> subcutaneously, d1-d7; mitoxantrone liposome 16 mg/m<sup>2</sup> d1; prednisone 60 mg/m<sup>2</sup>, d1–5; 28 days is a cycle of treatment. Patients who achieve CR/PR after four-six cycles could choose to undergo autologous hematopoietic stem cell transplantation, followed by chidamide maintenance therapy for 2 years.</p><p><b>Results:</b> A total of 13 treatment-naïve patients with TFH-derived PTCL were enrolled, of whom 46% were male, with a median age of 61 (39–70) years, 92% of whom had Ann Arbor stage III-IV, 31% of the patients had B symptoms, 69% of the patients had extranodal involvement, and 54% of the patients were EBER-positive. 46% of patients were IPI score 3, and 62% of patients were PIT score ≥ 2. The median number of treatment courses was 4 (4–7), and 3 patients (23%) underwent autologous hematopoietic stem cell transplantation, with a complete response (CR) rate of 100% and an overall best objective response rate (ORR) of 100%. At a median follow-up of 7 (4–12) months, with a median PFS of 7 (4–12) months, two patients (15%) experienced disease progression and one patient died due to disease progression. During CAMP regimen therapy, 6 patients (46%) developed grade 1–2 myelosuppression, which could be recovered after supportive therapy. Four patients (31%) developed pulmonary or urinary tract infections and were cured with active anti-infective therapy.</p><p><b>Conclusion:</b> Chidamide combined with azacitidine, mitoxantrone liposome and prednisone (CAMP regimen) in the treatment of treatment-naïve TFH-derived PTCL has a high complete response rate and a controllable safety profile, which is expected to become a new treatment option for treatment-naïve TFH-derived PTCL, but the cohort needs to be further expanded to verify its safety and efficacy.</p><p><b>Research</b> <b>funding declaration:</b> Clinical and translational medicine research project of Chinese Academy of Medical Sciences (2024-I2M-C&amp;T-B-083)</p><p><b>Encore Abstract:</b> Regional or national meetings with up to 1000 attendees</p><p><b>Keywords:</b> aggressive T-cell non-Hodgkin lymphoma; combination therapies; ongoing trials</p><p>No potential sources of conflict of interest.</p>","PeriodicalId":12882,"journal":{"name":"Hematological Oncology","volume":"43 S3","pages":""},"PeriodicalIF":3.3000,"publicationDate":"2025-06-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.1002/hon.70094_392","citationCount":"0","resultStr":"{\"title\":\"CHIDAMIDE IN COMBINATION WITH AZACITIDINE, MITOXANTRONE LIPOSOMES, AND PREDNISONE (CAMP REGIMEN) FOR TREATMENT-NAÏVE TFH-DERIVED PERIPHERAL T-CELL LYMPHOMA\",\"authors\":\"H. Liu,&nbsp;W. Liu,&nbsp;W. Huang,&nbsp;L. Qiu,&nbsp;D. Zou\",\"doi\":\"10.1002/hon.70094_392\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><b>Objective:</b> Peripheral T-cell lymphoma (PTCL) is a rare but challenging malignancy, in which the TFH (T follicular helper)-derived PTCL subtype has a poor prognosis and limited treatment options. In this study, chidamide in combination with azacitidine, mitoxantrone liposomes and prednisone (CAMP regimen) was used for the treatment of treatment-naïve TFH-derived peripheral T-cell lymphoma, aiming to evaluate the efficacy and safety of this treatment regimen and provide a new treatment option for clinical practice.</p><p><b>Methods:</b> This study is a multicenter, prospective phase II clinical trial (clinical trial ID: IIT2023003), the main purpose of which is to investigate the safety and preliminary efficacy (ORR rate) of chidamide in combination with azacitidine, mitoxantrone liposome and prednisone (CAMP regimen) in the treatment of treatment-naïve TFH-derived PTCL. Eligible treatment-naïve TFH-derived PTCL patients were included in the program who received CAMP regimen combination therapy, the specific regimen was: chidamide 30 mg/day orally, biw; azacitidine 75 mg/m<sup>2</sup> subcutaneously, d1-d7; mitoxantrone liposome 16 mg/m<sup>2</sup> d1; prednisone 60 mg/m<sup>2</sup>, d1–5; 28 days is a cycle of treatment. Patients who achieve CR/PR after four-six cycles could choose to undergo autologous hematopoietic stem cell transplantation, followed by chidamide maintenance therapy for 2 years.</p><p><b>Results:</b> A total of 13 treatment-naïve patients with TFH-derived PTCL were enrolled, of whom 46% were male, with a median age of 61 (39–70) years, 92% of whom had Ann Arbor stage III-IV, 31% of the patients had B symptoms, 69% of the patients had extranodal involvement, and 54% of the patients were EBER-positive. 46% of patients were IPI score 3, and 62% of patients were PIT score ≥ 2. The median number of treatment courses was 4 (4–7), and 3 patients (23%) underwent autologous hematopoietic stem cell transplantation, with a complete response (CR) rate of 100% and an overall best objective response rate (ORR) of 100%. At a median follow-up of 7 (4–12) months, with a median PFS of 7 (4–12) months, two patients (15%) experienced disease progression and one patient died due to disease progression. During CAMP regimen therapy, 6 patients (46%) developed grade 1–2 myelosuppression, which could be recovered after supportive therapy. Four patients (31%) developed pulmonary or urinary tract infections and were cured with active anti-infective therapy.</p><p><b>Conclusion:</b> Chidamide combined with azacitidine, mitoxantrone liposome and prednisone (CAMP regimen) in the treatment of treatment-naïve TFH-derived PTCL has a high complete response rate and a controllable safety profile, which is expected to become a new treatment option for treatment-naïve TFH-derived PTCL, but the cohort needs to be further expanded to verify its safety and efficacy.</p><p><b>Research</b> <b>funding declaration:</b> Clinical and translational medicine research project of Chinese Academy of Medical Sciences (2024-I2M-C&amp;T-B-083)</p><p><b>Encore Abstract:</b> Regional or national meetings with up to 1000 attendees</p><p><b>Keywords:</b> aggressive T-cell non-Hodgkin lymphoma; combination therapies; ongoing trials</p><p>No potential sources of conflict of interest.</p>\",\"PeriodicalId\":12882,\"journal\":{\"name\":\"Hematological Oncology\",\"volume\":\"43 S3\",\"pages\":\"\"},\"PeriodicalIF\":3.3000,\"publicationDate\":\"2025-06-16\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"https://onlinelibrary.wiley.com/doi/epdf/10.1002/hon.70094_392\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Hematological Oncology\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://onlinelibrary.wiley.com/doi/10.1002/hon.70094_392\",\"RegionNum\":4,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q2\",\"JCRName\":\"HEMATOLOGY\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Hematological Oncology","FirstCategoryId":"3","ListUrlMain":"https://onlinelibrary.wiley.com/doi/10.1002/hon.70094_392","RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q2","JCRName":"HEMATOLOGY","Score":null,"Total":0}
引用次数: 0

摘要

目的:外周T细胞淋巴瘤(PTCL)是一种罕见但具有挑战性的恶性肿瘤,其中TFH (T滤泡辅助细胞)衍生的PTCL亚型预后较差,治疗方案有限。本研究采用齐达胺联合阿扎胞苷、米托蒽醌脂体和强的松(CAMP方案)治疗treatment-naïve tfh源性外周t细胞淋巴瘤,旨在评价该治疗方案的有效性和安全性,为临床实践提供一种新的治疗方案。方法:本研究是一项多中心、前瞻性II期临床试验(临床试验ID: IIT2023003),主要目的是探讨小儿齐达胺联合阿扎胞苷、米托蒽醌脂体和强的松(CAMP方案)治疗treatment-naïve tfh源性PTCL的安全性和初步疗效(ORR率)。符合条件的treatment-naïve tfh源性PTCL患者纳入方案,接受CAMP方案联合治疗,具体方案为:齐达胺30 mg/天口服,口服;阿扎胞苷75mg /m2皮下注射,d1 ~ d7;米托蒽醌脂质体16 mg/m2 d1;强的松60 mg/m2, d1-5;28天是一个治疗周期。在4 - 6个周期后达到CR/PR的患者可选择自体造血干细胞移植,随后给予奇达胺维持治疗2年。结果:共纳入13例treatment-naïve tfh源性PTCL患者,其中46%为男性,中位年龄为61(39-70)岁,其中92%为Ann Arbor III-IV期,31%的患者有B症状,69%的患者有结外累及,54%的患者为eber阳性。46%的患者IPI评分为3分,62%的患者PIT评分≥2分。治疗疗程中位数为4(4 - 7)个,3例(23%)患者接受了自体造血干细胞移植,完全缓解率(CR)为100%,总体最佳客观缓解率(ORR)为100%。中位随访时间为7(4-12)个月,中位PFS为7(4-12)个月,2例患者(15%)出现疾病进展,1例患者因疾病进展而死亡。在CAMP方案治疗期间,6例患者(46%)出现1-2级骨髓抑制,经支持治疗后可恢复。4例患者(31%)出现肺部或尿路感染,经积极抗感染治疗治愈。结论:齐达胺联合阿扎胞苷、米托蒽醌脂体和泼尼松(CAMP方案)治疗treatment-naïve tfh源性PTCL具有较高的完全缓解率和可控的安全性,有望成为treatment-naïve tfh源性PTCL的一种新的治疗方案,但其安全性和有效性有待进一步扩大队列验证。研究经费申报:中国医学科学院临床与转化医学研究项目(2024-I2M-C&T-B-083)可参加摘要:1000人以下区域性或全国性会议关键词:侵袭性t细胞非霍奇金淋巴瘤;联合疗法;没有潜在的利益冲突来源。
本文章由计算机程序翻译,如有差异,请以英文原文为准。

CHIDAMIDE IN COMBINATION WITH AZACITIDINE, MITOXANTRONE LIPOSOMES, AND PREDNISONE (CAMP REGIMEN) FOR TREATMENT-NAÏVE TFH-DERIVED PERIPHERAL T-CELL LYMPHOMA

CHIDAMIDE IN COMBINATION WITH AZACITIDINE, MITOXANTRONE LIPOSOMES, AND PREDNISONE (CAMP REGIMEN) FOR TREATMENT-NAÏVE TFH-DERIVED PERIPHERAL T-CELL LYMPHOMA

Objective: Peripheral T-cell lymphoma (PTCL) is a rare but challenging malignancy, in which the TFH (T follicular helper)-derived PTCL subtype has a poor prognosis and limited treatment options. In this study, chidamide in combination with azacitidine, mitoxantrone liposomes and prednisone (CAMP regimen) was used for the treatment of treatment-naïve TFH-derived peripheral T-cell lymphoma, aiming to evaluate the efficacy and safety of this treatment regimen and provide a new treatment option for clinical practice.

Methods: This study is a multicenter, prospective phase II clinical trial (clinical trial ID: IIT2023003), the main purpose of which is to investigate the safety and preliminary efficacy (ORR rate) of chidamide in combination with azacitidine, mitoxantrone liposome and prednisone (CAMP regimen) in the treatment of treatment-naïve TFH-derived PTCL. Eligible treatment-naïve TFH-derived PTCL patients were included in the program who received CAMP regimen combination therapy, the specific regimen was: chidamide 30 mg/day orally, biw; azacitidine 75 mg/m2 subcutaneously, d1-d7; mitoxantrone liposome 16 mg/m2 d1; prednisone 60 mg/m2, d1–5; 28 days is a cycle of treatment. Patients who achieve CR/PR after four-six cycles could choose to undergo autologous hematopoietic stem cell transplantation, followed by chidamide maintenance therapy for 2 years.

Results: A total of 13 treatment-naïve patients with TFH-derived PTCL were enrolled, of whom 46% were male, with a median age of 61 (39–70) years, 92% of whom had Ann Arbor stage III-IV, 31% of the patients had B symptoms, 69% of the patients had extranodal involvement, and 54% of the patients were EBER-positive. 46% of patients were IPI score 3, and 62% of patients were PIT score ≥ 2. The median number of treatment courses was 4 (4–7), and 3 patients (23%) underwent autologous hematopoietic stem cell transplantation, with a complete response (CR) rate of 100% and an overall best objective response rate (ORR) of 100%. At a median follow-up of 7 (4–12) months, with a median PFS of 7 (4–12) months, two patients (15%) experienced disease progression and one patient died due to disease progression. During CAMP regimen therapy, 6 patients (46%) developed grade 1–2 myelosuppression, which could be recovered after supportive therapy. Four patients (31%) developed pulmonary or urinary tract infections and were cured with active anti-infective therapy.

Conclusion: Chidamide combined with azacitidine, mitoxantrone liposome and prednisone (CAMP regimen) in the treatment of treatment-naïve TFH-derived PTCL has a high complete response rate and a controllable safety profile, which is expected to become a new treatment option for treatment-naïve TFH-derived PTCL, but the cohort needs to be further expanded to verify its safety and efficacy.

Research funding declaration: Clinical and translational medicine research project of Chinese Academy of Medical Sciences (2024-I2M-C&T-B-083)

Encore Abstract: Regional or national meetings with up to 1000 attendees

Keywords: aggressive T-cell non-Hodgkin lymphoma; combination therapies; ongoing trials

No potential sources of conflict of interest.

求助全文
通过发布文献求助,成功后即可免费获取论文全文。 去求助
来源期刊
Hematological Oncology
Hematological Oncology 医学-血液学
CiteScore
4.20
自引率
6.10%
发文量
147
审稿时长
>12 weeks
期刊介绍: Hematological Oncology considers for publication articles dealing with experimental and clinical aspects of neoplastic diseases of the hemopoietic and lymphoid systems and relevant related matters. Translational studies applying basic science to clinical issues are particularly welcomed. Manuscripts dealing with the following areas are encouraged: -Clinical practice and management of hematological neoplasia, including: acute and chronic leukemias, malignant lymphomas, myeloproliferative disorders -Diagnostic investigations, including imaging and laboratory assays -Epidemiology, pathology and pathobiology of hematological neoplasia of hematological diseases -Therapeutic issues including Phase 1, 2 or 3 trials as well as allogeneic and autologous stem cell transplantation studies -Aspects of the cell biology, molecular biology, molecular genetics and cytogenetics of normal or diseased hematopoeisis and lymphopoiesis, including stem cells and cytokines and other regulatory systems. Concise, topical review material is welcomed, especially if it makes new concepts and ideas accessible to a wider community. Proposals for review material may be discussed with the Editor-in-Chief. Collections of case material and case reports will be considered only if they have broader scientific or clinical relevance.
×
引用
GB/T 7714-2015
复制
MLA
复制
APA
复制
导出至
BibTeX EndNote RefMan NoteFirst NoteExpress
×
提示
您的信息不完整,为了账户安全,请先补充。
现在去补充
×
提示
您因"违规操作"
具体请查看互助需知
我知道了
×
提示
确定
请完成安全验证×
copy
已复制链接
快去分享给好友吧!
我知道了
右上角分享
点击右上角分享
0
联系我们:info@booksci.cn Book学术提供免费学术资源搜索服务,方便国内外学者检索中英文文献。致力于提供最便捷和优质的服务体验。 Copyright © 2023 布克学术 All rights reserved.
京ICP备2023020795号-1
ghs 京公网安备 11010802042870号
Book学术文献互助
Book学术文献互助群
群 号:604180095
Book学术官方微信