[Translation] Single-arm, single-arm, first-line treatment of vebutuximab combined with cyclophosphamide, doxorubicin (hydroxydaunorubicin), and prednisone (CHP) in Chinese patients with CD30-positive (CD30+) peripheral T-cell lymphoma (PTCL) Open-label, multicenter Phase II study
主要目的
研究治疗结束后,根据恶性淋巴瘤[1]缓解修订标准,评价经IRF评估的ORR(CR和PR)。
评价A+CHP联合用药的安全性和耐受性。 次要目的
研究治疗结束后,根据恶性淋巴瘤缓解修订标准,评价经IRF评估的CR率。
根据恶性淋巴瘤缓解修订标准,评价经IRF评估的1年PFS率。
评价1年OS率。
根据2014 Lugano标准评价研究治疗结束后经IRF和研究者评估的ORR和CR率、至缓解时间(TTR)以及1年PFS率。
根据2014 Lugano标准,评价经研究者评估的缓解持续时间(DOR)。
收集血清/血浆浓度-时间数据,用于群体PK(popPK)分析。
评估免疫原性。 其他目的:
评价经研究者评估的PFS。 评价OS。
[Translation] the main purpose
After the end of the study treatment, the ORR (CR and PR) assessed by IRF was evaluated according to the revised response criteria for malignant lymphoma [1].
To evaluate the safety and tolerability of A+CHP combination therapy. secondary purpose
After the end of the study treatment, the CR rate assessed by IRF was evaluated according to the revised criteria for malignant lymphoma response.
According to the revised criteria for malignant lymphoma response, the 1-year PFS rate assessed by IRF was evaluated.
The 1-year OS rate was evaluated.
According to the 2014 Lugano criteria, the ORR and CR rate, time to remission (TTR) and 1-year PFS rate were evaluated by IRF and investigators after the end of the study treatment.
Investigator-assessed duration of response (DOR) was evaluated according to the 2014 Lugano criteria.
Serum/plasma concentration-time data were collected for population PK (popPK) analysis.
Assess immunogenicity. Other purposes:
Investigator-assessed PFS was evaluated. Evaluate OS.