Prospective Phase II Study for Treatment Peripheral T-cell Lymphoma, CHOP-14 Plus PEG-Filgrastim Followed by Alemtuzumab Consolidation
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 41
- 主要终点
- Feasibility of alemtuzumab consolidation after CHO(E)P 14 induction chemotherapy
研究概览
简要总结
Prospective Phase II Study for Treatment Peripheral T-cell Lymphoma, CHOP-14 Plus PEG-Filgrastim Followed by Alemtuzumab Consolidation
详细描述
Peripheral T cell lymphoma patients of all subtypes according to WHO are treated with an induction of 6 cycles of CHOP-etoposide-14 (if below 60 years of age) oder CHOP-14. If at least a PR is reached, consolidation with alemtuzumab, total dose 133 mg, is given i.v.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •all risk groups in international prognostic index
- •diagnosis of aggressive T-cell-lymphoma, confirmed by an excisional biopsy of a lymph node or by sufficiently extensive biopsy of an extranodal involvment, if there is no lymph node involvment.
- •these lymphomas comprise: peripheral T-cell lymphoma PTCL-NOS Lennert´s lymphoma T-zone lymphoma angioimmunoblastic T-cell-lymphoma
- •Performance status: ECOG (Eastern Cooperative Oncology Group Score) 0-3(Karnofsky index 40-100%)
- •written consent of the patient
- •Declaration of center participation
排除标准
- •Already initiated lymphoma therapy(exept for the prephase treatment specified for this study)
- •Serious accompanying disorder or impaired organ function
- •bone marrow involvement>25%
- •Known hypersensitivity to medications to be used
- •Know HIV-positivity
- •Active hepatitis infection, active CMV infection, prior florid tuberculosis
- •floride systemic infections
- •suspicion that patient compliance will be poor
- •Simultaneous participation in any the study protocol
- •prior chemo-or radiotherapy for malignancy
- •other concomitant malignant disease
- •Pregnancy or lactation period
研究组 & 干预措施
Alemtuzumab, antibody
alemtuzumab - anti CD 52 antibody administered as consolidation, total dose 133 mg
干预措施: Alemtuzumab (Drug)
结局指标
主要结局
Feasibility of alemtuzumab consolidation after CHO(E)P 14 induction chemotherapy
时间窗: average of 24 weeks (treatment duration)
A descriptive approach for the primary endpoint was chosen: Adherence to schedule of alemtuzumab consolidation (number of cycles, dosing, time) - comparison of planned vs given in pts receiving alemtuzumab
次要结局
- Overall survival(5 years)
- rate of complete remissions(at week 24 after initiation)
研究者
Lorenz, Trümper, MD
MD
University of Göttingen