Chidamide in combination with CHOP in previously untreated peripheral T-cell lymphoma with T follicular helper phenotype: Results of the phase II SWIFT trial.

Abstract

7082 Background: Peripheral T-Cell Lymphoma with T-follicular helper phenotype (PTCL-TFH), which mainly includes angioimmunoblastic T-cell lymphoma (AITL), is a biologically distinct subtype characterized by frequent epigenetic alterations. Chidamide is an oral, histone deacetylase (HDAC) inhibitor that targets HDAC subtypes 1, 2, 3, and 10, has shown encouraging activity in R/R PTCL-TFH. This study aimed to evaluate the efficacy and safety of chidamide in combination with CHOP (cyclophosphamide, doxorubicin, vincristine, and prednisone) in previously untreated PTCL-TFH patients. Methods: This is a multicenter, open-label, single-arm phase II study (NCT05572983). Patients with previously untreated PTCL-TFH were enrolled and received chidamide (20 mg, oral, biweekly) combined with CHOP regimen for up to six induction cycles. Patients achieving complete response (CR) after induction entered a maintenance phase with chidamide for up to two years. The primary endpoint was CR rate. Secondary endpoints included overall response rate (ORR), progression-free survival (PFS), overall survival (OS), and safety. Results: Between May 2023 and July 2025, a total of 47 patients were enrolled, and enrollment was completed. All patients had the AITL subtype. The median age was 62 years (IQR, 54–67), and 25.5% were female. Advanced-stage disease (stage III–IV) was present in 85.0% of patients, and 48.9% had extranodal involvement. The median number of induction cycles was 5 (range, 1–6), with 33 patients completing six cycles of induction therapy. Among 35 patients who underwent post-treatment PET/CT evaluation, the best CR rate during the induction phase was 85.2% (30/35), with an ORR of 100%. At the end of induction therapy, the CR rate was 87.9% (29/33), and the ORR remained 100%. As of October 2025, disease progression was observed in 10 patients. The most common grade 3–4 adverse events were neutropenia (42.6%), thrombocytopenia (19.1%), infections (17.0%), anemia (6.4%), and elevated transaminases (2.1%). Conclusions: Chidamide in combination with CHOP demonstrated promising efficacy with a manageable safety profile in previously untreated PTCL-TFH patients. A randomized controlled trial is currently ongoing to further validate these findings (NCT06947967). Clinical trial information: NCT05572983 . Baseline characteristics. Characteristics Patients(n=47) Age, years (median [IQR]) 62 (54-67) Sex Male 35 (74.4%) Female 12 (25.5%) IPI score 0-2 25 (53.1%) ≥3 22 (46.9%) Ann Arbor Stage I-II 7 (14.8%) III-IV 40 (75.2%) Extranodal involvement No 24 (51.1%) Yes 23 (48.9%) Data are shown as number (%).