ISRCTN51837425进行中（未招募）3 期
A Randomised Evaluation of Molecular guided therapy for Diffuse large B-cell Lymphoma with Bortezomib
Southampton University Hospitals NHS Trust (UK)0 个研究点目标入组 1,128 人开始时间: 2011年3月30日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 1,128
研究概览
简要总结
2019 results in https://www.ncbi.nlm.nih.gov/pubmed/30948276 (added 24/04/2019)
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Histologically confirmed Diffuse large B-cell lymphoma (DLBCL), expressing CD20
- •2. Sufficient diagnostic material should be available to forward to Haematological Malignancy Diagnostic Service (HDMS) for gene expression profiling and central pathology review
- •3. Core biopsies are acceptable, however the molecular profiling success rate is inferior compared to larger surgically acquired tissue samples
- •4. Best diagnostic practice encourages investigators to seek the latter approach whenever clinically appropriate
- •5. Not previously treated for lymphoma and fit enough to receive combination chemoimmunotherapy with curative intent
- •6. Age >18 years
- •7. Stage IAX (bulk defined as lymph node diameter >10cm) to stage IV disease and deemed to require a full course of chemotherapy
- •8. Eastern Cooperative Oncology Group (ECOG) performance status 0-2
- •9. Adequate bone marrow function with platelets >100x109/L; neutrophils >1.0x109/L at study entry, unless lower figures are attributable to lymphoma
- •10. Serum creatinine <150µmol/L, measured or calculated creatinine clearance >30mls/min, serum bilirubin <35µmol/L and transaminases <2.5x upper limit of normal at the time of study entry, unless attributable to lymphoma
- •11. Cardiac function sufficient to tolerate 300mg/m2 of doxorubicin
- •12. A pre-treatment echocardiogram is not mandated, but recommended in patients considered at higher risk of anthracycline cardiotoxicity
- •13. No concurrent uncontrolled medical condition
- •14. Life expectancy >3 months
- •15. Adequate contraceptive precautions for all patients of child bearing potential
- •16. A negative serum pregnancy test for females of child bearing potential or those <2 years after the onset of the menopause
- •17. Patients will have provided written informed consent
- •18. Target gender: male and female
- •19. Lower age limit 18 years
排除标准
- •1. Previous history of treated or untreated indolent lymphoma, however newly diagnosed patients with DLBCL who are found to also have small cell infiltration of the bone marrow or other diagnostic material (discordant lymphoma) will be eligible.
- •2. Uncontrolled systemic infection
- •3. History of cardiac failure of uncontrolled angina
- •4. Clinical CNS involvement
- •5. Serological positivity for Hepatitis C, B or known HIV infection. Viral serological testing is not mandated for study entry, but considered standard of care. Patients who are HepBsAg positive will not be eligible.
- •6. Serious medical or psychiatric illness likely to affect participation or that may compromise the ability to give informed consent
- •7. Active malignancy other than fully excised squamous or basal cell carcinoma of the skin or carcinoma in situ of the uterine cervix in the preceding 5 years
- •8. History of allergic reaction to substances containing boron or mannitol
- •9. Patient unwilling to abstain from green tea and preparations made from green tea as bortezomib may interact with these
- •10. Any co-existing medical or psychological condition that would compromise ability to give informed consent
研究者
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