ISRCTN11038174进行中（未招募）2 期
Randomised, open label study of rituximab/ibrutinib vs rituximab/chemotherapy in older patients with untreated mantle cell lymphoma
niversity Hospitals Plymouth NHS Trust0 个研究点目标入组 400 人开始时间: 2015年10月21日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 400
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •Current inclusion criteria as of 18/04/2023:
- •1. Male/female patients aged 60 years and over
- •2. Pathologically confirmed MCL, with documentation of monoclonal B cells that have a chromosome translocation t(11;14)(q13;q32) and/or overexpress cyclin D1
- •3. Stage II-IV disease, measurable by imaging and requiring treatment in the opinion of the treating clinician
- •4. No previous treatment for MCL (other than localised radiotherapy or 7-day pulse of steroids for symptom control)
- •5. Performance status ECOG 0-2
- •6. Absolute neutrophil count >1.0 x 10(9)/L or platelets >100 x 10(9)/L independent of growth factor support or unless related to lymphoma
- •7. AST and/or ALT <3xULN
- •8. Total bilirubin =1.5xULN unless bilirubin rise is due to Gilbert’s syndrome or of non-hepatic origin
- •9. Calculated creatinine clearance >30 mL/min
- •10. Cardiac function sufficient to tolerate either rituximab-CHOP or rituximab-bendamustine chemotherapy
- •11. Able to give voluntary written informed consent
- •12. Willingness and ability to take Pneumocystis jiroveci pneumonia prophylaxis
- •Previous inclusion criteria:
- •1. Male/female patients 60 years and over
- •2. Pathologically confirmed MCL, with documentation of monoclonal B cells that have a chromosome translocation t(11;14)(q13;q32) and/or overexpress cyclin D1
- •3. Stage II-IV disease, measurable by imaging and requiring treatment in the opinion of the treating clinician
- •4. No previous treatment for MCL (other than localised radiotherapy or 7 day pulse of steroids for symptom control)
- •5. Performance status ECOG 0-2
- •6. Absolute neutrophil count >1.0x109/L or platelets >100x109 /L independent of growth factor support or unless related to lymphoma
- •7. AST and/or ALT <3xULN
- •8. Total bilirubin =1.5xULN unless bilirubin rise is due to Gilbert’s syndrome or of non-hepatic origin
- •9. Calculated creatinine clearance >30mL/min
- •10. Cardiac function sufficient to tolerate 300mg/m2 of doxorubicin. A pre-treatment echocardiogram is not mandated, but recommended in patients considered at higher risk of anthracycline cardiotoxicity
- •11. Able to give voluntary written informed consent
排除标准
- •Current exclusion criteria as of 18/04/2023:
- •1. Patients considered fit enough to undergo autologous or allogeneic stem cell transplant as treatment for MCL
- •2. Known serological positivity for HBV, HCV, HIV
- •3. Vaccinated with live vaccines within 4 weeks prior to Day 1 of Cycle 1
- •4. Major surgery within 2 weeks prior to Day 1 of Cycle 1
- •5. Diagnosed with or treated for any other malignancy than MCL within 2 years prior to Day 1 of Cycle 1 (except BCC, SCC or any in situ malignancy)
- •6. Active systemic infection requiring treatment
- •7. Male subjects with female partners of childbearing potential who are unwilling to use appropriate contraception methods whilst on study treatment
- •8. Women who are pregnant or breastfeeding
- •9. Serious medical or psychiatric illness likely to interfere with participation in this clinical study
- •10. Concurrent treatment with another investigational agent
- •11. CNS involvement of MCL
- •Previous exclusion criteria:
- •1. Patients considered fit enough to undergo autologous or allogeneic stem cell transplant as treatment for MCL
- •2. Known serological positivity for HBV, HCV, HIV
- •3. Vaccinated with live vaccines within four weeks prior to Day 1 of Cycle 1
- •4. Major surgery within two weeks prior to Day 1 of Cycle 1
- •5. Diagnosed with or treated for any other malignancy than MCL within 2 years prior to Day 1 of Cycle 1 (except BCC, SCC or any in situ malignancy)
- •6. Active systemic infection requiring treatment
- •7. Male subjects with female partners of childbearing potential who are unwilling to use appropriate contraception methods whilst on study treatment (see section 8.4)
- •8. Women who are pregnant or breastfeeding
- •9. Serious medical or psychiatric illness likely to interfere with participation in this clinical study
- •10. Concurrent treatment with another investigational agent
研究者
相似试验
进行中（未招募）
1 期
Ibrutinib for untreated mantle cell lymphomantreated symptomatic Mantle Cell LymphomaMedDRA version: 20.0 Level: HLT Classification code 10026798 Term: Mantle cell lymphomas System Organ Class: 100000004851EUCTR2015-000832-13-FIPlymouth Hospitals NHS Trust10
进行中（未招募）
1 期
Ibrutinib for untreated mantle cell lymphomaEUCTR2015-000832-13-GBniversity Hospitals Plymouth NHS Trust400
进行中（未招募）
1 期
Ibrutinib for untreated mantle cell lymphomantreated symptomatic Mantle Cell LymphomaMedDRA version: 20.0Level: HLTClassification code 10026798Term: Mantle cell lymphomasSystem Organ Class: 100000004851EUCTR2015-000832-13-DKniversity Hospitals Plymouth NHS Trust400
进行中（未招募）
1 期
Ibrutinib for untreated mantle cell lymphomantreated symptomatic Mantle Cell LymphomaMedDRA version: 20.0Level: HLTClassification code 10026798Term: Mantle cell lymphomasSystem Organ Class: 100000004851EUCTR2015-000832-13-SEPlymouth Hospitals NHS Trust400
进行中（未招募）
1 期
Study of Rituximab and Ibrutinib (RI) versus Dexamethasone, Rituximab and Cyclophosphamide (DRC) as initial therapy for Waldenström's macroglobulinaemiaWaldenström's macroglobulinaemiaEUCTR2019-001261-33-GBniversity College London148