{"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, W. Liu, W. Huang, L. Qiu, 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&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, W. Liu, W. Huang, L. Qiu, 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&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}
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.
Researchfunding 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
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.