Combination of mitoxantrone hydrochloride liposome with cyclophosphamide, vincristine, and prednisone for patients with treatment-naive peripheral T-cell lymphoma: A multicenter, open-label, single-ar
3 hours ago
- #Phase 1b trial
- #CMOP regimen
- #PTCL
- Study evaluates mitoxantrone hydrochloride liposome (Lipo-MIT) combined with cyclophosphamide, vincristine, and prednisone (CMOP) for untreated peripheral T-cell lymphoma (PTCL).
- Phase 1b trial with dose-escalation (12-21 mg/m² Lipo-MIT) and expansion phases; recommended phase 2 dose (RP2D) established at 18 mg/m².
- 38 patients enrolled; no dose-limiting toxicities reported. Grade ≥3 adverse events included neutrophil decrease (76.3%) and white-cell count decrease (73.7%).
- Complete response rate (CRR) was 54.3%, overall response rate (ORR) 88.6%. At RP2D, CRR and ORR improved to 64.7% and 94.1%, respectively.
- Median progression-free survival was 20.8 months; median overall survival not reached. Lipo-MIT showed favorable pharmacokinetics and manageable safety.