EUCTR2013-005541-36-FI进行中（未招募）1 期
A phase II trial of ibrutinib, lenalidomide and rituximab for patients with relapsed/refractory mantle cell lymphoma. - PHILEMO
ordic Lymphoma Group0 个研究点目标入组 50 人开始时间: 2015年2月20日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 50
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. Age >18 years
- •2. Histologically confirmed (according to the WHO 2008, and upcoming 2015 classification) mantle cell lymphoma stage II-IV,
- •3. Received at least 1 prior rituximab-containing chemotherapy regimen.
- •4. Documented relapse or disease progression following the last anti-MCL treatment
- •5. At least 1 measurable site of disease (>1.5 cm long axis)
- •6. WHO performance status 0 – 3
- •7. Written informed consent.
- •8. Female subjects of childbearing potential must:
- •a. Understand that the study medication is expected to have a teratogenic risk
- •b. Agree to use, and be able to comply with, effective contraception without interruption, 4 weeks before starting study drug, throughout study drug therapy (including dose interruptions) and for 3 months after
- •the end of study drug therapy, even if she has amenorrhoea.
- •c. Women of childbearing potential must have a negative serum (betahuman chorionic gonadotropin [ß-hCG]) or urine pregnancy test at screening. Women who are pregnant or breastfeeding are ineligible for
- •this study.
- •9. Male subjects must
- •a. Agree to use condoms throughout study drug therapy, during any dose interruption and for one month after cessation of study therapy if their partner is of childbearing potential and has no contraception.
- •b. Agree not to donate semen during study drug therapy and for one week after end of study drug therapy.
- •10. All subjects must
- •a. Agree to abstain from donating blood while taking study drug therapy and for one week following discontinuation of study drug therapy.
- •b. Agree not to share study medication with another person and to return all unused study drug to the investigator.
- •11. Hematology values must be within the following limits:
- •a. Absolute neutrophil count (ANC) = 1000/mm3 independent of growth factor support
- •b. Platelets =100,000/mm3 or =50,000/mm3 if bone marrow involvement independent of transfusion support in either situation
- •12. Biochemical values within the following limits:
- •a. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) = 3 x upper limit of normal (ULN)
- •b. Total bilirubin = 1.5 x ULN unless bilirubin rise is due to Gilbert's syndrome or of non-hepatic origin
- •c. Serum creatinine = 2 x ULN or estimated Glomerular Filtration Rate (Cockroft-Gault) = 40 mL/min/1.73m2
- •13. Sign (or their legally-acceptable representatives must sign) an informed consent document indicating that they understand the purpose of and procedures required for the study, including biomarkers, and are
- •willing to participate in the study.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 2
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 6
排除标准
- •1. Chemotherapy or radiotherapy within 3 weeks, therapeutic antibodies within 4 weeks, radioimmunotherapy within 10 weeks, or major surgery
- •within 4 weeks of inclusion.
- •2. Known central nervous system lymphoma.
- •3. Other active malignancy.
- •4. Psychiatric illness or condition which could interfere with the subjects' ability to understand the requirements of the study.
- •5. Requirement of corticosteroid therapy at a dose >10 mg prednisolone/day.
- •6. Major surgery within 4 weeks of inclusion.
- •7. History of stroke or intracranial hemorrhage within 6 months prior to inclusion.
- •8. Requirement of anticoagulation treatment with warfarin or equivalent vitamin K antagonists (eg, phenprocoumon).
- •9. Requirement of treatment with strong or moderate CYP3A inhibitors (see Appendix 4).
- •10. Clinically significant cardiovascular disease such as uncontrolled or symptomatic arrhythmias, congestive heart failure, or myocardial infarction within 6 months of screening, or any Class 3 (moderate) or Class 4 (severe) cardiac disease as defined by the New York Heart Association Functional Classification.
- •11. Vaccination with live, attenuated vaccines within 4 weeks of inclusion.
- •12. Known history of human immunodeficiency virus (HIV) or active Hepatitis C Virus or active Hepatitis B Virus infection or any uncontrolled active systemic infection requiring intravenous (IV) antibiotics.
- •13. Any life-threatening illness, medical condition, or organ system dysfunction which, in the investigator's opinion, could compromise the subject's safety, interfere with the absorption or metabolism of ibrutinib
- •capsules or lenalidomide tablets, or put the study outcomes at undue risk.
- •14. Known hypersensitivity or allergy to rituximab, lenalidomide or ibrutinib.
研究者
相似试验
进行中（未招募）
1 期
A phase II trial of ibrutinib, lenalidomide and rituximab for patients with relapsed/refractory mantle cell lymphoma.EUCTR2013-005541-36-SEordic Lymphoma Group50
进行中（未招募）
1 期
A phase II trial of ibrutinib, lenalidomide and rituximab for patients with relapsed/refractory mantle cell lymphoma.Relapsed/refractory mantle cell lymphoma,MedDRA version: 20.0Level: LLTClassification code 10026799Term: Mantle cell lymphoma NOSSystem Organ Class: 100000004864EUCTR2013-005541-36-DKordic Lymphoma Group50
已完成
2 期
A Phase II Study of Ibrutinib, Rituximab and mini-CHOP (cyclophosphamide, doxorubicin, vincristine, and prednisone) therapy in very elderly patients with newly diagnosed Diffuse Large B-Cell Lymphoma (DLBCL)ACTRN12615000551594Australasian Leukaemia and Lymphoma Group80
进行中（未招募）
1 期
Lenalidomide and Ibrutinib in Treating Patients With Relapsed or Refractory B-Cell Non-Hodgkin LymphomaRecurrent Diffuse Large B-Cell LymphomaRecurrent Follicular LymphomaRecurrent Lymphoplasmacytic LymphomaRecurrent Mantle Cell LymphomaRecurrent Marginal Zone LymphomaRefractory Diffuse Large B-Cell LymphomaRefractory Follicular LymphomaRefractory Lymphoplasmacytic LymphomaRefractory Mantle Cell LymphomaRefractory Marginal Zone LymphomaNCT01955499National Cancer Institute (NCI)39
进行中（未招募）
1 期
Rituximab, Lenalidomide, and Ibrutinib in Treating Patients With Previously Untreated Stage II-IV Follicular LymphomaAnn Arbor Stage II Grade 1 Contiguous Follicular LymphomaAnn Arbor Stage II Grade 1 Non-Contiguous Follicular LymphomaAnn Arbor Stage II Grade 2 Contiguous Follicular LymphomaAnn Arbor Stage II Grade 2 Non-Contiguous Follicular LymphomaAnn Arbor Stage II Grade 3 Contiguous Follicular LymphomaAnn Arbor Stage II Grade 3 Non-Contiguous Follicular LymphomaAnn Arbor Stage III Grade 1 Follicular LymphomaAnn Arbor Stage III Grade 2 Follicular LymphomaAnn Arbor Stage III Grade 3 Follicular LymphomaAnn Arbor Stage IV Grade 1 Follicular LymphomaAnn Arbor Stage IV Grade 2 Follicular LymphomaAnn Arbor Stage IV Grade 3 Follicular LymphomaNCT01829568National Cancer Institute (NCI)33