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临床试验/NCT03884205
NCT03884205Unknown不适用

GDPE/CEOPE Compared With CEOPE as the First-line Therapy for Newly Diagnosed Patients With Peripheral T-Cell Lymphoma

Shandong Provincial Hospital1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2019年4月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
120
试验地点
1
主要终点
RR

研究概览

简要总结

Peripheral T-cell Lymphoma (PTCL) is a heterogenic malignancy with poor outcome. There is no standardized treatment protocol for this kind of lymphoma. So, clinical trials are encouraged by National Comprehensive Cancer Network (NCCN) for those patients. Former studies confirmed that GDP (Gemcitabine, Dexamethasone, and Cis-platinum) is superior with CHOP (Cyclophosphamide, Adriamycin, Vincristine, and Prednisone). Combination with etoposide can improve the outcome of some patients with high risk factors. The aim of our study is to compare the response and survival rate of GDPE/CEOPE (gemcitabine, cis-platinum, etoposide, and dexamethasone/cyclophosphamide, vincristine, pharmorubicin, etoposide, and prednisone) with those of CEOPE regimen, looking forward to its superiority in efficacy and safety for the newly diagnosed adult patients with PTCL.

详细描述

Peripheral T-cell Lymphoma (PTCL) is a heterogenic malignancy with poor outcome. Five-year PFS (progression-free survival) and OS (overall survival) for these patients received classic CHOP regimen is less than 30%. High-dose intensive chemotherapy doesn't demonstrate better response. At present, there is no standardized treatment protocol for this kind of lymphoma. So, clinical trials are encouraged by NCCN for those patients.

For the less efficacy of CHOP or CHOP-like regimen, multi-drug combination strategy has been the therapy tendency in PTCL. Zhang et al, reported that GDP compared with CHOP as the therapy strategy for PTCL-NOS (Not Otherwise Specified). The response rate was 78.57% in GDP group and 60.00% in CHOP group, respectively. DFS (disease-free survival) was 9.79 and 4.2 months in above two groups. They concluded that GDP is superior to CHOP. The main side-effect of two regimens is hematological toxicity. Combination with etoposide can improve the outcome of some patients with high risk factors. Furthermore, high-dose combined with ASCT (autologous stem cell transplantation) has been the first-line therapy for PTCL. Some refractory/relapsed patients with PTCL will benefit from allogeneic bone marrow transplantation. However, about 30% patients with PTCL have no chance to receive ASCT for multiple reasons. So, it is urgent to explore new combination-therapy regimen to improve the outcome for patients with PTCL.

The aim of our study is to compare the response and survival rate of GDPE/CEOPE (gemcitabine, cis-platinum, etoposide, and dexamethasone/cyclophosphamide, vincristine, pharmorubicin, etoposide, and prednisone) with those of CEOPE (/cyclophosphamide, vincristine, pharmorubicin, etoposide, and prednisone ) regimen, looking forward to its superiority in efficacy and safety for the newly diagnosed adult patients with PTCL.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
16 Years 至 75 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Peripheral T Cell Lymphoma, Not Otherwise Specified
  • Angioimmunoblastic T Cell Lymphoma
  • ALK-negative Anaplastic Large Cell Lymphoma
  • Enteropathy Associated T Cell Lymphoma
  • Subcutaneous Panniculitis Like T Cell Lymphoma
  • Acute T-cell Leukemia/Lymphoma

排除标准

  • woman in pregnancy or lactation
  • allergic to any intervention drug
  • unsuitable to the study due to severe complication
  • enrolled to other study during the past 6 months
  • NK/T lymphoma ALK-positive Anaplastic Large Cell Lymphoma

结局指标

主要结局

RR

时间窗: 1 year

Response Rate (including complete response \& partial response)

次要结局

  • PFS(1 year)

研究者

申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Wang Xin

Department Director

Shandong Provincial Hospital

研究点 (1)

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