Background: Peripheral T-Cell Lymphoma with T-follicular helper phenotype (PTCL-TFH), which mainly includes angioimmunoblastic T-cell lymphoma (AITL), is characterized by recurrent mutations affecting epigenetic regulators. Chidamide is an oral, subtype-selective histone deacetylase (HDAC) inhibitor that targets HDAC subtypes 1, 2, 3, and 10. It has been approved for relapsed or refractory (R/R) PTCL, advanced breast cancer, R/R adult T-cell leukemia-lymphoma, and previously untreated diffuse large B-cell lymphoma with double expression of MYC and BCL2. Single-agent chidamide has shown safety and efficacy in R/R PTCL-TFH. This study aimed to assess the efficacy and safety of chidamide in combination with CHOP (cyclophosphamide, doxorubicin, vincristine, and prednisone) in previously untreated PTCL-TFH.

Methods: This multicenter, open-label, single-arm phase II study was conducted in China (NCT05572983). Previously untreated PTCL-TFH patients received chidamide combined with CHOP for up to 6 cycles in the induction therapy phase. Patients achieving complete response (CR) received chidamide 20 mg biweekly as maintenance therapy. The primary endpoint was CR rate at the end of treatment, with secondary endpoints including overall response rate (ORR), progression-free survival (PFS), overall survival (OS), and safety profiles.

Results: Between May 2023 and May 2024, 17 previously untreated PTCL-TFH patients were enrolled in this study. The median age was 62 years (range: 38-73); 80% were male, and all had AITL subtype. Among the 14 evaluable patients, the ORR was 85.7%, with a CR rate of 71.4%. Follow-up is ongoing for PFS results. A total of 17 patients were included in the safety analysis. Common grade 3 or 4 adverse events (AE) included neutropenia (64.7%), leukopenia (52.9%), and thrombocytopenia (23.5%), respectively. The majority of AEs were reversible and clinically manageable.

Conclusions: This study demonstrated that chidamide plus CHOP is safe, well tolerated, and effective in previously untreated PTCL-TFH patients. Further randomized controlled studies are warranted to assess this promising combination.

Disclosures

No relevant conflicts of interest to declare.

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2024
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