Phase II study of the novel antifolate agent pralatrexate in combination with the histone deacetylase inhibitor romidepsin for the treatment of patients with mature T-cell lymphoma.
Phase II study of the novel antifolate agent pralatrexate in combination with the histone deacetylase inhibitor romidepsin for the treatment of patients with mature T-cell lymphoma.
复制标题
新型抗叶酸剂普拉曲沙联合组蛋白脱乙酰酶抑制剂罗米地辛治疗成熟 T 细胞淋巴瘤患者的 II 期研究。
DOI：
10.1080/10428194.2024.2329996
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发表时间：
2024
影响因子：
2.6
通讯作者：
Amengual,JenniferE
中科院分区：
文献类型：
--
作者：
RyuTiger,YunKyoung;Jain,Salvia;Barta,StefanK;Tolu,Seda;Estrella,Brian;Sawas,Ahmed;Lue,JenniferK;Francescone,MarkM;Pro,Barbara;Amengual,JenniferE
之前，我们在复发性/难治性（R/R）淋巴瘤患者中进行了普拉曲沙和罗米地辛联合治疗的I期研究，随后在未经治疗或R/R成熟T细胞淋巴瘤（MTCL）患者中进行了多中心II期研究。患者每2周一次接受普拉曲沙25 mg/m2和罗米地辛12 mg/m2治疗。14例患者可评价疗效。总有效率为35.7%，其中CR为14.3%，疾病控制为50%。mDOR为8.2个月，mPFS为3.6个月，mOS为20.2个月。胃肠道副作用最常见，高达33%;只有一个血液学毒性3级贫血。结合I期和II期研究的MTCL患者（N= 28）的结果，ORR为53.5%，CR为21.4%，疾病控制率为67.8%，DOR为7.2个月。该组合是安全的，但并不优于其他组合策略。试验注册：www.clinicaltrials.gov（NCT 01947140）。
Previously, we conducted a Phase I study of the combination of pralatrexate and romidepsin in patients with relapsed/refractory (R/R) lymphomas and subsequently conducted a multicenter Phase II study in patients with untreated or R/R mature T cell lymphomas (MTCL). Patients received pralatrexate 25 mg/m2and romidepsin 12 mg/m2every 2 weeks. Fourteen patients were evaluable for efficacy. Overall response rate was 35.7% with CR in 14.3% and disease control in 50%. The mDOR was 8.2 months, mPFS was 3.6 months, and mOS was 20.2 months. Gastrointestinal side effects were most common in up to 33%; there was only one hematologic toxicity of grade 3 anemia. Combining results of MTCL patients from the Phase I and II studies (N= 28), the ORR was 53.5% with CR in 21.4%, disease control in67.8%, and DOR of 7.2 months. The combination was safe however does not out-perform other combination strategies.Trial Registration:www.clinicaltrials.gov (NCT 01947140).