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 30mg/day orally, biw; azacitidine 75mg/m2 subcutaneously, d1-d7; mitoxantrone liposome 16mg/m2 d1; prednisone 60mg/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 20 treatment-naïve patients with TFH-derived PTCL were enrolled, of whom 45% were male, with a median age of 56 (39-70) years, 95% of whom had Ann Arbor stage III-IV, 45% of the patients had B symptoms, 75% of the patients had extranodal involvement, and 55% of the patients were EBER-positive. 40% of patients were IPI score 3, and 50% of patients were PIT score≥2.

The median number of treatment courses was 5 (4-8), and 4 patients (20%) underwent autologous hematopoietic stem cell transplantation, with a complete response (CR) rate of 95%，a partial response (PR) rate of 5% and an overall best objective response rate (ORR) of 100%. At a median follow-up of 10 (3-17) months, the estimated 1-year PFS and OS rate of all patients was 61% and 78% respectively. During CAMP regimen therapy, 13 patients (65%) developed myelosuppression, with a 25% incidence of grade 3-4 myelosuppression, which could be recovered after supportive therapy. Eight patients (40%) 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.

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2025
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