NCT00791947已完成2 期
A Nordic Phase II Study of Peripheral T-cell Lymphomas Based on Dose-intensive Induction and High-dose Consolidation With Autologous Stem Cell Rescue
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 166
- 试验地点
- 9
- 主要终点
- Time to treatment failure
研究概览
简要总结
This is a phase II prospective non-randomised clinical trial in newly diagnosed and previously untreated adult patients in the age range 18-60 (67) years with peripheral T-cell lymphoma.
The treatment schedule will consist of three phases: induction and high-dose consolidation, followed by autologous stem cell rescue. There will be two different induction schedules: one for patients in the age range 18-60 years and one for patients aged over 60 years.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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 67 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Previously untreated patients with newly diagnosed peripheral T-cell lymphoma of all stages. However, patients with nodal stage IA non-bulky disease (<10cm) can be treated individually at the discretion of the responsible physician.
- •Following histologic subtypes (WHO classification) are eligible for inclusion in the study:
- •Peripheral T-cell lymphomas, unspecified Angioimmunoblastic T-cell lymphoma NK/T nasal-type T-cell lymphoma Enteropathy-type T-cell lymphoma Primary systemic, alk-negative anaplastic large cell lymphoma (T-or null phenotype) Hepatosplenic T-cell lymphoma Subcutaneous panniculitis-like T-cell lymphoma
- •NB: Patients should not enter the treatment program before confirmation of the histo-pathological diagnosis by the referral center pathologist
- •Age 18-60 years. Patients in the age range 61-67 years may be included in this protocol at discretion of the treating physician.
- •formed consent based on oral and written patient information (Appendix I)
排除标准
- •Primary cutaneous T-or null-cell anaplastic large-cell lymphoma
- •Alk-positive, primary systemic T-or null-cell anaplastic large-cell lymphoma
- •WHO Performance Status grade 4 (Appendix II)
- •Patients with severe cardiac (i.e. severe heart failure requiring symptomatic treatment or a cardiac ejection fraction of less than 45%), pulmonary, neurologic, psychiatric, renal, hepatic or metabolic disease.
- •Pregnancy. N.B: Women of childbearing potential should be strongly advised to apply appropriate contraceptive precautions during the entire treatment period.
- •Patients with concomitant malignancies except for non-melanoma skin tumors or stage 0 (in situ) cervical carcinoma.
- •Patients with seropositivity for the human immunodeficiency virus.
- •Patients with other active and therapeutically uncontrolled infection.
- •Psychological, familial, social or other condition/-s potentially hampering compliance and follow-up.
结局指标
主要结局
Time to treatment failure
时间窗: 5 years
次要结局
- Overall survival(5 years)
研究者
研究点 (9)
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