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1691 Combination of Mitoxantrone Hydrochloride Liposome with Gemcitabine, Cisplatin and Dexamethasone in Patients with Relapsed or Refractory Peripheral T Cell Lymphoma: A Phase I Study

Program: Oral and Poster Abstracts
Session: 625. T Cell, NK Cell, or NK/T Cell Lymphomas: Clinical and Epidemiological: Poster I
Hematology Disease Topics & Pathways:
Clinical trials, Research, Lymphomas, Non-Hodgkin lymphoma, Clinical Research, T Cell lymphoma, Diseases, Aggressive lymphoma, Lymphoid Malignancies
Saturday, December 7, 2024, 5:30 PM-7:30 PM

Chong Wei1*, Shengyu Zhou2*, Shuangnian Xu3*, Hongmei Jing, MD4, Hui Liu5*, Wei Zhang1* and Daobin Zhou, MD1*

1Department of Hematology, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing, China
2Department of Hematology, Cancer Hospital Chinese Academy of Medical Sciences, Beijing, China
3Department of Hematology, Southwest Hospital, Third Military Medical University,(Army Medical University), Chongqing, China, Chongqing, China
4Department of Hematology, Lymphoma Research Center, Peking University Third Hospital, Beijing, China
5Department of Hematology, Beijing Hospital, Beijing, China

Background: Peripheral T-cell lymphomas (PTCL) are a heterogeneous group of mature aggressive T-cell non-Hodgkin’s lymphomas characterized by poor prognosis, highlighting the urgent need for novel therapeutic strategies. The combination of gemcitabine, cisplatin and dexamethasone (GDP) is recommended as the second-line treatment regimen according to lymphoma guidelines. Mitoxantrone hydrochloride liposome (Lipo-MIT) is a nano-drug that has been approved as the first treatment option for relapsed/refractory (r/r) PTCL, and has shown certain efficacy and safety in a pivotal phase Ⅱ study. This study aims to investigate the safety and efficacy of combining Lipo-MIT with GDP regimen (MGDP) in patients (pts) with r/r PTCL (NCT05441761).

Methods: Pts with r/r PTCL were recruited in this prospective, multicenter, open-label phase I study with a 3+3 dose-escalation design. Lipo-MIT was administered at three dose levels (DL1: 12 mg/m2, DL2: 16 mg/m2, DL3: 20 mg/m2, d1). Gemcitabine was given at 1000 mg/m2, cisplatin at 75 mg/m2, and dexamethasone at 40 mg on day 1 of each cycle (Q3W), and up to 6 cycles of therapy were planned. The primary endpoint is to explore the recommended phase II dose (RP2D) of Lipo-MIT. Secondary endpoints were to assess the tolerability (i.e. dose-limiting toxicity (DLT)), complete response (CR) rate, objective response rate (ORR), progression-free survival (PFS), overall survival (OS) and safety.

Results: At data cut-off on 17 July 2024, 9 eligible pts (DL1: n=3, DL2: n=3, DL3: n=3) were enrolled including 3 with angioimmunoblastic T-cell lymphoma (AITL), 5 with PTCL-NOS and 1 with ALK positive anaplastic large cell lymphoma (ALCL). Among them, 6 cases (66.7%) were refractory pts. The median age of all pts is 46 (range, 31-70) years, and 4 pts (44.4%) were IPI score 3-5. 8 pts (88.9%) had advanced stage III or IV (Ann Arbor stage). No DLT occurred in this phase I study. And the RP2D was 20 mg/m2 for Lipo-MIT. The CR rate and ORR were 33.3% (3/9, 95% CI 7.5%-70.1%) and 55.6% (5/9, 95% CI 21.2%-86.3%), respectively. Besides, in refractory pts, the CR rate was 33.3% (2/6) and ORR rate was 66.7% (4/6). With a median follow-up of 5.1 (range, 0.03-20.2) months currently, the median PFS and OS will be reported after long-term follow-up. The common grade 3/4 Treatment-related adverse events (TRAEs) were mainly hematological toxicity, including neutropenia (66.7%), leucopenia (44.4%), anaemia (33.3%) and thrombocytopenia (11.1%). Overall, safety in all pts was tolerable during this study.

Conclusions: Lipo-MIT plus GDP (MGDP) regimen proves an promising efficacy in r/r PTCL pts with manageable safety profiles. A phase II, multi-center, single-arm study is ongoing to confirm and validate the findings from this study.

Disclosures: No relevant conflicts of interest to declare.

*signifies non-member of ASH