810MO - Combination of mitoxantrone hydrochloride liposome with chidamide in patients with relapsed or refractory peripheral T cell lymphoma: A phase l/II study

Background

Relapsed or refractory (R/R) peripheral T cell lymphoma (PTCL) is an aggressive and heterogeneous malignancy without standard treatment. Either mitoxantrone hydrochloride liposome (PLM60) monotherapy or chidamide (CHI) monotherapy has shown certain efficacy and safety in R/R PTCL. This study aimed to explore the safety and efficacy of PLM60 plus CHI (PLM60-CHI) in patients (pts) with R/R PTCL.

Methods

Phase I was 3+3 design with three levels of PLM60 (14, 17 and 20mg/m²) plus chidamide 20mg administered (Biw). After the first cycle, dose-limiting toxicity (DLT) was assessed to determine the maximum tolerated dose (MTD) of PLM60. Phase II consisted of dose expansion at the recommended phase II dose (RP2D) to further evaluate the safety and efficacy of the PLM60-CHI regimen.

Results

At data cutoff on March 10, 2024, the study has enrolled 21 pts (phase I, n=9 and phase II, n=12). Among all pts (median age: 49 years, range: 26-64 years; IPI score 3-5 with 8 pts (38.1%)) who had disease stage, 16 pts (76.2%) were in stage III-IV. Additionally, 13 pts (61.9%) were refractory to prior therapy. No DLTs were observed at 14, 17 and 20 mg/m². RP2D was determined to be PLM60 at 20 mg/m² in combination with CHI at 20 mg. The grade 3/4 treatment-related adverse events (TRAEs) with an incidence ≥10% were leucopenia (52.4%), neutropenia (66.7%), lymphopenia (42.9%), thrombocytopenia (23.8%) and anemia (23.8%). At date cutoff, the phase II study is ongoing. Eight pts in phase II were evaluable, showing an objective response rate (ORR) of 75% (6/8) and a complete response (CR) rate of 37.5% (3/8). The ORR of 16 pts in phases I and II was 56.3% (9/16) and the CR rate was 31.3% (5/16). After a median follow-up of 3.8 months, both the median progression-free survival (PFS) and median overall survival (OS) have not yet been reached. Table: 810MO

Conclusions

PLM60-CHI regimen proves a promising efficacy in R/R PTCL with manageable safety.

Clinical trial identification

NCT05527275.

Editorial acknowledgement

Legal entity responsible for the study

Sun Yat-sen University Cancer Center.

Funding

Has not received any funding.

Disclosure

All authors have declared no conflicts of interest.