PRELIMINARY RESULTS OF A PHASE 2 STUDY OF CHIDAMIDE, GEMCITABINE, VINORELBINE, AND MITOXANTRONE LIPOSOME (CHI‐GVM) IN RELAPSED/REFRATORY PERIPHERAL T‐CELL LYMPHOMA

Introduction: Patients with relapsed or refractory peripheral T-cell lymphoma (R/R PTCL) have a poor prognosis. There is no effective treatment for these patients. Mitoxantrone hydrochloride liposome showed high antitumor activity and low toxicity in lymphoma. In phase II clinical study of mitoxantrone monotherapy R/R lymphoma, the overall response rate (ORR) complete remission (CRR) PTCL, not otherwise specified (PTCL, NOS) reached 34.4% 18.8%. Our aimed to explore whether combination chemotherapy regimen containing liposomes can improve efficacy survival PTCL. Methods: A Phase II, multicenter, single-arm, open-label planned at our center. All patients enrolled are PTCL will receive induction therapy chidamide (20 mg, twice week), gemcitabine (1 g/m2, d1), vinorelbine mg/m2, d1) (Chi-GVM) 2–4 cycles. aged 60 years younger (CR) / unconfirmed (CRu) partial (PR) after cycles received autologous stem cell transplantation (ASCT) prior maintenance therapy. ASCT over old CR/CRu/PR mg week) until intolerance disease progression (PD). Efficacy was assessed by contrast-enhanced CT PET-CT every 2 during treatment. The primary endpoint ORR secondary duration (DOR) and1-year progression-free (1y-PFS). Results: total 7 were treated Chi-GVM between September 2022 February 2023, including 3 NOS; two ALK negative anaplastic large (ALCL, ALK-); monomorphic epitheliotropic intestinal (MEITL). Five male female included, mean age 57 years, one patient post-ASCT. Two re-staged stage I–II five III–IV treatment, extranodal lesions stomach, skin intestinal. Four evaluable efficacy, 1 lost follow-up, did reach assessment time. Of patients, had best CR experienced PD, achieved consolidation ASCT. Grade adverse events occurred 5 cases leukopenia, 4 neutropenia, case thrombocytopenia, hepatic insufficiency. One myocardial damage before kept stable used. Keywords: Aggressive non-Hodgkin Chemotherapy, Late Effects Lymphoma Survivors No conflicts interests pertinent abstract.