Positron Emission Tomography Guided Therapy of Aggressive Non-Hodgkin's Lymphomas
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 1,073
- 试验地点
- 1
- 主要终点
- Time to treatment failure
研究概览
简要总结
The main purpose of the PETAL trial is to determine whether patients with aggressive non-Hodgkin's lymphomas with a persistently positive PET scan after two cycles of chemotherapy benefit from a change of the treatment protocol.
详细描述
Positron emission tomography performed after two cycles of (R-)CHOP chemotherapy (interim-PET) has been shown to predict long-term outcome in patients with aggressive non-Hodgkin's lymphomas. Patients with early normalization of pathological PET findings have an excellent prognosis, while patients with a persistently pathological PET scan have a high risk of non-response or relapse.
Patients with a negative interim-PET scan (part A of the trial) will be randomized to receive either another four cycles of the (R-)CHOP regimen (arm A1) or four cycles of the (R-)CHOP regimen plus two additional doses of rituximab (arm A2). Randomisation in part A of the trial was stopped when the number of patients required was reached (128 patients in each treatment arm). Since then patients have been uniformly treated according to arm A2.
Patients with a persistently positive interim-PET scan (part B of the trial) will be randomized to either continue treatment with another six (R-)CHOP cycles (arm B1) or switch to an alternative protocol used for the treatment of Burkitt's lymphoma (arm B2: six blocks according to the so-called B-ALL protocol of the German ALL study group).
Patients refractory to or relapsing within two years after treatment according to parts A or B of the trial will receive age-adapted salvage protocols (patients < 60 years: high-dose chemotherapy with autologous stem cell transplantation; patients > 60 years: (R-)ESHAP protocol)(part C of the trial).
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aggressive B-cell or T-cell non-Hodgkin's lymphoma
- •Pathological pre-treatment PET scan
- •Performance status ECOG 0-3
- •Age 18 - 80 years
- •Ability to understand the purpose of the study and act accordingly
- •Willingness to use adequate contraception
- •Informed consent
排除标准
- •Burkitt's lymphoma
- •Primary central nervous system lymphoma
- •Previous chemo- and/or radiotherapy
- •Other cancer within preceding 5 years
- •HIV infection, active viral hepatitis or other uncontrolled infection
- •Other medical conditions precluding administration of planned therapy
- •Pregnancy or lactation
研究组 & 干预措施
B1
Six cycles of the (R-)CHOP regimen.
干预措施: (R-)CHOP protocol (Drug)
B2
Six blocks of the B-ALL protocol.
干预措施: B-ALL protocol (Drug)
A1
Four cycles of the (R-)CHOP regimen.
干预措施: (R-)CHOP protocol (Drug)
A2
Four cycles of the (R-)CHOP regimen plus two additional doses rituximab.
干预措施: (R-)CHOP protocol (Drug)
结局指标
主要结局
Time to treatment failure
时间窗: Two years
次要结局
- Response rate, overall survival, disease-free survival, toxicity, quality of life(Two years)
研究者
Ulrich Duehrsen
Prof. Dr. Ulrich Duehrsen
University Hospital, Essen