EUCTR2011-004146-18-GB进行中（未招募）不适用
Cyclophosphamide, doxorubicin, vincristine and prednisolone (CHOP) versus gemcitabine, cisplatin and methyl prednisolone (GEM-P) in the first line treatment Of T-cell Lymphoma, a multicentre randomised phase II study - CHEMO-T
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 186
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Previously untreated, histologically proven T-cell Lymphoma (any of the following): - Peripheral T-cell lymphoma Not Otherwise Specified (PTCL NOS) - Systemic Anaplastic large cell lymphoma (ALCL) ALK negative cases only - Angioimmunoblastic T-cell lymphoma - Hepatosplenic gamma/ delta T-cell lymphoma 2. Bulky stage I not being considered for reduced chemotherapy plus involved field radiotherapy or stage II, III or IV. 3. Age =18 years on the day of signing informed consent. 4. WHO performance status 0, 1 or 2. 5. Baseline 18FDG-PET scans must demonstrate FDG avid disease compatible with CT defined anatomical tumour sites. 6. Adequate bone marrow, cardiac, renal, hepatic and respiratory function.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 150
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 36
排除标准
- •1. Documented or symptomatic central nervous system involvement or leptomeningeal disease. 2. Patients with negative FDG-PET/CT scan at baseline 3. Any other clinically significant disease or co-morbidity which may adversely affect the safe delivery of treatment within this trial. 4. Prior malignancy within the last 5 years 5. Treatment with another investigational agent within 30 days of commencing study treatment. 6. Known positive tests for human immunodeficiency virus (HIV) infection, hepatitis C virus, acute or active hepatitis B infection. 7. Patients with poorly controlled diabetes mellitus
研究者
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