EUCTR2008-008202-52-PT进行中（未招募）1 期
DOUBLE BLIND RANDOMIZED PHASE III STUDY OF LENALIDOMIDE (REVLIMID®) MAINTENANCE VERSUS PLACEBO IN RESPONDING ELDERLY PATIENTS WITH DLBCL AND TREATED WITH R-CHOP IN FIRST LINE - REMARC
YSARC0 个研究点目标入组 650 人开始时间: 2009年7月27日最近更新:
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
- 650
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
- •For patients registered at the time of initial diagnosis:
- •Patient with histologically proven CD20+ diffuse large B-cell
- •lymphoma (DLBCL) (WHO classification 2008) including clinical subtypes
- •(primitive mediastinal, intravascular, etc.). Patients with De Novo
- •Transformed DLBCL from low grade lymphoma (Follicular, other..) may
- •also be included. Patients with DLBCL associated with some small cell
- •infiltration in bone marrow may also be included
- •- 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+ Agressive B-cell lymphoma unclassifiable
- •Previously untreated with chemo- or radiotherapy
- •For patients registered after response evaluation to first line treatment
- •with R-CHOP:
- •Patient with histologically proven CD20+ diffuse large B-cell
- •lymphoma (DLBCL) (WHO classification 2008) including clinical subtypes
- •(primitive mediastinal, intravascular, etc.). Patients with De Novo
- •Transformed DLBCL from low grade lymphoma (Follicular, other...) may
- •also be included. Patients with DLBCL associated with some small cell
- •infiltration in bone marrow may also be included
- •- 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+ Agressive B-cell lymphoma unclassifiable
- •Have reached a CR or PR (Cheson 2007) after first line treatment with
- •at least 6 cycles of R-CHOP-14 regimens and up to 8 cycles of R-CHOP-21
- •Previously untreated with Radiotherapy
- •For all patients:
- •Aged from 60 to 80 years at time of registration
- •Ann Arbor stages II-IV at time of initial diagnosis
- •aaIPI = 1 at time of initial diagnosis
- •Eastern Cooperative Oncology Group [ECOG] performance status 0-2
- •Minimum life expectancy of 3 months
- •Voluntary signed informed consent before performance of any study
- •related procedure not part of normal medical care, with the
- •understanding that consent may be withdrawn by the patient at any time
- •without prejudice to future medical care.
- •The following laboratory values at screening
- •? Absolute neutrophil count (ANC) = 1 000.106/L and Platelets = 60
- •000.106/L, unless these abnormalities are related to bone marrow
- •infiltration.
- •? Aspartate transaminase (AST) = 5 x ULN; Alanine transaminase (ALT)
- •= 5 x ULN; Total bilirubin = 1.5 x ULN;
- •? Creatinine clearance > 30 ml/min (as calculated by the Cockcroft-
- •Gault formula)
- •Females of childbearing potential (FCBP)† must:
- •? Have a negative medically supervised pregnancy test prior to starting
- •of study therapy. She must agree to ongoing pregnancy testing during
- 另有 11 项未显示
排除标准
- •For all patients:
- •Any other histological type of lymphoma, Burkitt included.
- •Any history of treated or non-treated small B-cell lymphoma
- •Central nervous system or meningeal involvement by lymphoma
- •Contraindication to any drug contained in the chemotherapy regimen
- •For example: cardiac contra-indication to anthracyclines (alteration of
- •Left Ventricular Function defined by LVEF<50%) neurological
- •contraindication
- •to vincristine (peripheral neuropathy of WHO grade = 2).
- •Myocardial infarction during last 3 months or unstable coronary
- •disease or uncontrolled chronic symptomatic congestive heart
- •insufficiency NYHA III - IV
- •Uncontrolled hypertension
- •Uncontrolled diabetes mellitus as defined by the investigator
- •Active systemic infection requiring treatment.
- •Previously known HIV positive serology
- •Active hepatitis B or C
- •Prior history of malignancies other than lymphoma within 3 years
- •(except for complete resection of basal cell carcinoma, squamous cell
- •carcinoma of the skin, or in situ malignancy. 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 (ie, 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.
- •Serious medical or psychiatric illness likely to interfere with
- •participation in this clinical study.
研究者
相似试验
进行中（未招募）
1 期
STUDY OF LENALIDOMIDE IN MAINTENANCE VERSUS PLACEBO IN RESPONDING ELDERLY PATIENTS WITH B CELL LYMPHOMA AND PREVIOUSLY TREATED WITH R-CHOPDiffuse Large B Cell LymphomaMedDRA version: 14.1Level: PTClassification code 10012818Term: Diffuse large B-cell lymphomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2008-008202-52-PLYSARC650
进行中（未招募）
1 期
STUDY OF LENALIDOMIDE IN MAINTENANCE VERSUS PLACEBO IN RESPONDING ELDERLY PATIENTS WITH B CELL LYMPHOMA AND PREVIOUSLY TREATED WITH R-CHOPEUCTR2008-008202-52-ATYSARC725
进行中（未招募）
1 期
STUDY OF LENALIDOMIDE IN MAINTENANCE VERSUS PLACEBO IN RESPONDING ELDERLY PATIENTS WITH B CELL LYMPHOMA AND PREVIOUSLY TREATED WITH R-CHOPDiffuse Large B Cell LymphomaMedDRA version: 20.0 Level: PT Classification code 10012818 Term: Diffuse large B-cell lymphoma System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2008-008202-52-BEYSARC725
进行中（未招募）
3 期
Study of Lenalidomide Maintenance Versus Placebo in Responding Elderly Patients With Diffuse Large B cell Lymphoma (DLBCL) and Treated With Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone (R-CHOP)Diffuse large B cell lymphoma (DLBCL) in elderly patientsCancer - Lymphoma (non Hodgkin's lymphoma) - Low grade lymphomaACTRN12611000085976Australasian Leukaemia and Lymphoma Group54
进行中（未招募）
1 期
Trial of Lenalidomide/dexamethasone With or Without Elotuzumab in Subjects with Previously Untreated Multiple Myeloma.ntreated Multiple MyelomaMedDRA version: 21.0Level: LLTClassification code 10028228Term: Multiple myelomaSystem Organ Class: 100000004864EUCTR2010-022445-20-GRBristol-Myers Squibb International Corporation862