Abstract
Peripheral T-cell lymphoma (PTCL) is a heterogeneous and aggressive group of lymphoma, accounting for 25%~30% of non-Hodgkin lymphomas in China. The standard initial treatments for PTCL are CHOP or CHOEP, but the outcomes remain suboptimal. The Phase I study of mitoxantrone hydrochloride liposome (Lipo-MIT) in combination with cyclophosphamide, vincristine, etoposide and prednisone (CMOEP) regimen was presented at the 2024 ASH (Abstract #PB6403) and published in Frontiers in Immunology (2025 Apr 11;16:1551723.), demonstrating promising efficacy and manageable safety in treatment-naïve (TN) PTCL patients (pts). Based on these findings, a phase II study (NCT06433362) is currently underway, with interim data disclosed at this conference.
Eligible pts were aged 18-65 years with histologically confirmed TN PTCLs. Pts received Lipo-MIT (18 mg/m2) combined with COEP regimen (cyclophosphamide at 750 mg/m2 on day 1, vincristine at 1.4 mg/m2 on day 1, etoposide at 60 mg/m2 on days 1-3, and prednisone at 100 mg on days 1-5) every 21 days for six cycles. The primary endpoint was the complete response rate (CRR), with key secondary endpoints including the objective response rate (ORR), progression-free survival (PFS), overall survival (OS), and safety. Adverse events (AEs) were documented according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) v5.0.
From June 25, 2024 to March 28, 2025, the study had enrolled 20 pts, including 11 with PTCL-NOS (peripheral T-cell lymphoma not otherwise specified), 5 with AITL (angioimmunoblastic T-cell lymphoma), and 4 with ALCL (anaplastic large cell lymphoma; 2 ALK +, 2 ALK-).
The median age was 58 years (Q1-Q3: 40-66), with 10 males (50.0%). Sixteen (80.0%) pts were diagnosed with stage III-IV, and 4 pts had IPI score of 3-5. The median dose of Lipo-MIT was 16.8 mg/m2 (Q1-Q3: 13.0-17.9), and the median treatment duration were 6 cycles. At data cutoff, 19 pts had undergone at least one efficacy assessment, showing a CRR of 68.4% (13/19) and an ORR of 94.7% (18/19). Among 8 PET/CT-evaluable patients, the CRR was 87.5% (7/8) with ORR 100.0% (8/8). With a median follow-up of 4.2 months, the median PFS and OS were not reached, and the 6-month duration of response (DoR) rate was 100.0%.
The most common ≥ grade 3 treatment-related adverse events (TRAEs) with an incidence ≥10% were lymphocytopenia (55.0%), leucopenia (45.0%), neutropenia (45.0%), anemia (15.0%), thrombocytopenia (15.0%), pneumonia (25.0%) and febrile neutropenia (15%).
Conclusion:Building on the completed phase I results, initiation of a phase II trial has demonstrated encouraging efficacy and manageable safety in pts with TN-PTCL. The Phase II trial is currently ongoing.
