NCT00970385已完成3 期
Multicentric Study About Treatment of High Grade Peripheral T Cell Lymphoma in Adults. LTP Study Comparison Between VIP ABVD Versus CHOP
University Hospital, Grenoble1 个研究点 分布在 1 个国家目标入组 95 人开始时间: 1995年1月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 95
- 试验地点
- 1
- 主要终点
- Comparison between EFS rate of CHOP/21 versus VIP-rABVD in newly diagnosed PTCL.
研究概览
简要总结
This is a multicenter randomized trial evaluating induction treatment with VIP-reinforced-ABVD (VIP-rABVD) versus CHOP/21 in patients with newly diagnosed peripheral T cell lymphoma.
详细描述
Induction therapy:
ARM 1: 6 Chemotherapy courses = 3 VIP alternated with 3 ABVD ARM 2: 8 Chemotherapy courses = CHOP every 21 days
Consolidation therapy:
For all patients if CR = radiotherapy 40GY / 5X1,8 GY per week
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
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •newly diagnosed untreated PTCL
- •age 18 and 70 years
- •performance status ≤ 2
- •Ann Arbor stage I to IV
- •normal cardiac ventricular ejection fraction over 50%
- •normal hepatic function (asat, ALAT, PAL < 2.5 ULN)
排除标准
- •cutaneous form of PTCL
- •previous treatment
- •age < 18 and > 70
- •performance status > 2
- •abnormal cardiac or hepatic functions
- •HIV-, HCV- or HBV- positivity
研究组 & 干预措施
CHOP 21
Active Comparator
Induction therapy CHOP every 21 days:
- cyclophosphamide 750 mg/m2 intravenously (IV) day 1
- doxorubicin 50 mg/m2 IV day 1
- vincristine 1,4 mg/m2 (maximum 2 mg) day 1
- prednisone 100 mg/m2/D from D1 to D5.
干预措施: CHOP21 (Drug)
CHOP 21
Active Comparator
Induction therapy CHOP every 21 days:
- cyclophosphamide 750 mg/m2 intravenously (IV) day 1
- doxorubicin 50 mg/m2 IV day 1
- vincristine 1,4 mg/m2 (maximum 2 mg) day 1
- prednisone 100 mg/m2/D from D1 to D5.
干预措施: Radiotherapy consolidation (Radiation)
VIP/ABVD arm
Experimental
VIP cycle:
- etoposide 100 mg/m2/D IV from D1 to D3
- ifosfamide 1000 mg/m2/D from D1 to D5
- cisplatin 20 mg/m2/D as a continuous infusion from D1 to D5
ABVD cycle:
- doxorubicin50 mg/m2/D on D1 and D14
- bleomycin 10 mg/m2/D
- vinblastine 10 mg/m2/D
- dacarbazine 375 mg/m2/D Each alternating cycle was repeated three times for a total of 6 cycles (3 VIP, 3 rABVD).
干预措施: VIP/ABVD (Drug)
VIP/ABVD arm
Experimental
VIP cycle:
- etoposide 100 mg/m2/D IV from D1 to D3
- ifosfamide 1000 mg/m2/D from D1 to D5
- cisplatin 20 mg/m2/D as a continuous infusion from D1 to D5
ABVD cycle:
- doxorubicin50 mg/m2/D on D1 and D14
- bleomycin 10 mg/m2/D
- vinblastine 10 mg/m2/D
- dacarbazine 375 mg/m2/D Each alternating cycle was repeated three times for a total of 6 cycles (3 VIP, 3 rABVD).
干预措施: Radiotherapy consolidation (Radiation)
结局指标
主要结局
Comparison between EFS rate of CHOP/21 versus VIP-rABVD in newly diagnosed PTCL.
时间窗: 2 years
次要结局
- Overall survival (OS)(6 years)
- response rate at the end of the treatment(6-8 months)
- progression free survival (PFS)(6 years)
- hematotoxicity(6 months)
研究者
研究点 (1)
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