CEOP/IVE/GDP Compared With CEOP as the First-line Therapy for Newly Diagnosed Adult Patients With Peripheral T-cell Lymphoma (PTCL)
试验速览
- 阶段
- 2 期
- 入组人数
- 106
- 试验地点
- 4
- 主要终点
- Percentage of patients with complete remission （CR）
研究概览
简要总结
Peripheral T-cell Lymphoma (PTCL) is a heterogenic malignancy with poor outcome. Five-year PFS and OS for these patients received classic CHOP regimen (cyclophosphamide, vincristin, doxorubicin and prednisone) 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.
详细描述
For the less efficacy of CHOP or CHOP-like regimen, multi-drug combination strategy has been the therapy tendency in PTCL. The novel regimen IVE/MTX (ifosfamide, etoposide，epirubucin/methotrexate)-ASCT(autologous stem-cell transplantation ) was piloted for patients eligible for intensive treatment, followed by auto-stem cell transplantation. Five-years PFS (progression-free survival) and OS (overall survival) were 52% and 60% respectively, significantly improved compared with the historical group treated with anthracycline-based chemotherapy. The encouraged results were extended to the peripheral T cell lymphoma-non specified (PTCL-NOS). Former studies reported that GDP (gemcitabine, cis-platinum, and dexamethasone) 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 with CHOP. The main side-effect of two regimens is hematological toxicity. Furthermore, high-dose combined with ASCT has been the first-line therapy for PTCL. However, only about 30% patients with PTCL have 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 CEOP/IVE/GDP (cyclophosphamide, vincristin, epirubucin and prednisone/ ifosfamide, epirubucin, and etoposide/ gemcitabine, cis-platinum, and dexamethasone) with those of CEOP 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
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Newly diagnosed, histologically confirmed the following pathology subtype according to WHO 2008 classification: 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, and hepatosplenic T-cell lymphoma.
- •≥ 16 years of age.
- •Performance status of 2 or less.
- •Has no history of malignancy.
- •Has radiologically measurable disease.
- •Life expectancy ≥6 months.
- •Voluntarily sign an informed consent.
排除标准
- •Pathology subtype with NK/T cell lymphoma, ALK positive-ALCL.
- •Primary central nervous system (CNS) lymphoma.
- •Previous systemic chemotherapy or local therapy.
- •Has undergone hematopoietic stem-cell transplantation (HSCT).
- •Has active infectious disease requiring general antibiotics, anti-fungal or anti-virus therapy.
- •Has uncontrollable cardiocerebrovascular, coagulative, autoimmune, or serious infectious disease.
- •Echocardiography shows left ventricular ejection fraction (LVEF) ≤ 50%.
- •Inadequate renal, hepatic or bone marrow function
- •Active liver or biliary disease.
- •Has other uncontrollable medical condition that may interfere with their participation in the study.
- •Woman in pregnancy or lactation.
- •Patient is known to be positive for Human immunodeficiency virus (HIV) infection.
研究组 & 干预措施
CEOP/IVE/GDP chemotherapy regimen
2 cycles of CEOP(cyclophosphamide,vincristine, epirubucin and prednisone),2 cycles of IVE(ifosfamide, epirubucin, etoposide)and 2 cycles of GDP(gemcitabine, cis-platinum, and dexamethasone)
干预措施: CEOP/IVE/GDP chemotherapy regimen (Drug)
CEOP chemotherapy regimen for 6 cycles
6 cycles of CEOP regimen(cyclophosphamide,vincristin,epirubucin and prednisone)
干预措施: CEOP chemotherapy regimen for 6 cycles (Drug)
结局指标
主要结局
Percentage of patients with complete remission （CR）
时间窗: 6 months
次要结局
- progression-free survival(2 year since randomization)
- overall survival(2 year since randomization)
- overall response rate(6 months)
- adverse events(from randomization to one month after last cycle of treatment)
研究者
Wang Xin
Director of Hematology Department
Shandong Provincial Hospital