EUCTR2013-000450-22-PT进行中（未招募）1 期
Sub-cutaneous Rituximab-miniCHOP versus Sub-cutaneous Rituximab-miniCHOP + lenalidomide (R2-miniCHOP) in Diffuse Large B Cell Lymphoma for patients of 80 years old or more. A multicentric phase III study of the LYSA. - SENIOR
YSARC0 个研究点目标入组 250 人开始时间: 2015年1月8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
- 250
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
- •Patients must satisfy all following criteria to be enrolled in the study:
- •1. Patient with histologically proven CD20+ diffuse large B-cell lymphoma (DLBCL) (WHO classification 2008) including all clinical subtypes (primary mediastinal, intravascular, etc…), with all aaIPI. May also be included:
- •- De Novo transformed DLBCL from low grade lymphoma (Follicular, other...) and DLBCL associated with some small cell Infiltration in bone marrow or lymph node
- •- Or CD20+ B-cell lymphoma, with intermediate features between DLBCL and Burkitt or with intermediate features between DLBCL
- •and classical Hodgkin lymphoma
- •- Or CD20+ Follicular lymphoma grade 3B
- •- Or CD20+ Aggressive B-cell lymphoma unclassifiable
- •2. With a CD10 immunostaining performed by the participating center pathologist
- •3. Aged = 80 years old
- •4. Ann Arbor stage II, III or IV
- •5. Patient previously untreated for DLBCL
- •6. ECOG performance status = 2
- •7. With a minimum life expectancy of 3 months
- •8. Negative HIV, HBV and HCV serologies test within 4 weeks before inclusion (except after hepatitis B vaccination or for patients who are HBs Ag negative, anti-HBs positive and/or anti-HBc positive but viral DNA negative)
- •9. Patient able to give his consent and having signed a written Informed consent
- •10. Patient affiliated to social security system, if applicable
- •11. Male patients must practice complete abstinence or agree to use a condom during sexual contact with a pregnant female or a female of childbearing potential while participating in the study, during dose interruptions, and for 3 months following study drug discontinuation, even if they have undergone a successful vasectomy
- •12. All patients must agree to fulfill the global Lenalidomide Pregnancy Prevention Risk Management Plan as applicable according to the randomization arm (experimental arm)
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 250
排除标准
- •Presence of any of the following will exclude a patient from enrollment:
- •1. Any other histological type of lymphoma, Burkitt included
- •2. Any history of treated or non-treated small-B cell lymphoma
- •3. Central nervous system or meningeal involvement by lymphoma
- •4. Contra-indication to any drug contained in the chemotherapy regimens ; for anthracycline use, ejection fraction should be > 50%
- •5. Any serious active disease (according to the investigator’s decision)
- •6. History of deep venous thrombosis or arterial thromboembolism events within the past 12 months before inclusion
- •7. Poor renal function (creatinine clearance < 40 ml/min, according to MDRD formula)
- •8. Poor hepatic function (total bilirubin level >30 µmol/l, transaminases >2.5 maximum normal level) unless these abnormalities are related to the lymphoma
- •9. Poor bone marrow reserve as defined by neutrophils <1.5 G/l or platelets <100 G/l, unless related to bone marrow infiltration
- •10. Any history of cancer during the last 5 years with the exception of non-melanoma skin tumors or stage 0 (in situ) cervical carcinoma Patients previously diagnosed with prostate cancer are eligible if (1) their disease was T1-T2a, N0, M0, with a Gleason score =7, and a
- •prostate specific antigen (PSA) =10 ng/mL prior to initial therapy, (2) they had definitive curative therapy (i.e., prostatectomy or radiotherapy) 2 years before Day 1 of Cycle 1, and (3) at a minimum 2 years following therapy they had no clinical evidence of prostate cancer, and their PSA was undetectable if they underwent prostatectomy or <1 ng/mL if they did not undergo prostatectomy
- •11. Treatment with any investigational drug within 30 days before planned first cycle of chemotherapy and during the study
- •12. Prior treatment with anti-CD20 monoclonal antibody or alemtuzumab within 3 months prior to start of therapy
- •13. Prior use of lenalidomide
- •14. Prior = Grade 3 allergic reaction/hypersensitivity to thalidomide
- •15. Prior = Grade 3 rash or any desquamating (blistering) rash while taking thalidomide
- •16. Subjects with = Grade 2 neuropathy
- •17. Adult patient under tutelage
- •18. Female of childbearing potential are excluded. (Note: Females are defined as not of childbearing potential if there is documentation of natural menopause for at least 24 consecutive months, a hysterectomy or bilateral oophorectomy”)
研究者
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