EUCTR2006-007082-36-GR进行中（未招募）不适用
A Phase I/II trial of lenalidomide combined with cyclophosphamide and intermediate dose dexamethasone in patients with primary (AL) systemic amyloidosis - CDR in amyloidosis
Hellenic Oncology Cooperative Group0 个研究点目标入组 55 人开始时间: 2007年7月18日最近更新:
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 55
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.Understand and voluntarily sign an informed consent form.
- •2.Age >18 years at the time of signing the informed consent form.
- •3.Able to adhere to the study visit schedule and other protocol requirements.
- •4.Confirmed diagnosis of AL amyloidosis
- •5.Need for treatment in the judgment of their treating physician
- •6.Evaluable or measurable disease defined by any of the following:
- •I.Measurable serum free light chains > 10 mg/dL, kappa or lambda, provided ?/? ratio is abnormal (measurable disease) or abnormal ?/? ratio (evaluable)
- •II.monoclonal protein in the serum>1 g/dL
- •7.ECOG Performance Status (PS) 0, 1, 2 or 3
- •8.Laboratory test results within these ranges:
- •Absolute neutrophil count >=1.0 x 109/L
- •Platelet count >= 100 x 109/L
- •Serum creatinine <= 2.5 mg/dL
- •Total bilirubin < 2 mg/dL
- •AST (SGOT) and ALT (SGPT) < 2 x ULN or <5 x ULN if liver involvement is present.
- •9.Women of childbearing potential (WCBP)† must have a negative serum or urine pregnancy test with a sensitivity of at least 50 mIU/mL 10 – 14 days prior to therapy and repeated within 24 hours of starting study drug and must begin TWO acceptable methods of birth control, one highly effective method and one additional effective method AT THE SAME TIME, at least 4 weeks before she starts taking lenalidomide. Women must also agree to ongoing pregnancy testing. Men must agree not to father a child and agree to use a condom if his partner is of child bearing potential.
- •10.Disease free of prior malignancies for > 5 years with exception of currently treated basal cell, squamous cell carcinoma of the skin, or carcinoma insitu” of the cervix or breast
- •11.Able to take aspirin (81 or 325 mg) daily as prophylactic anticoagulation. (patients intolerant to ASA may use low molecular weight heparin).
- •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
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1.Patients with symptomatic multiple myeloma with asymptomatic biopsy confirmed AL amyloidosis
- •2.Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form.
- •3.Pregnant or breast feeding females. (Lactating females must agree not to breast feed while taking lenalidomide).
- •4.Any condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study.
- •5.Use of any other experimental drug or therapy within 28 days of baseline.
- •6.Known hypersensitivity to thalidomide.
- •7.The development of erythema nodosum if characterized by a desquamating rash while taking thalidomide or similar drugs.
- •8.Any prior use of lenalidomide.
- •9.Concurrent use of other anti-cancer agents or treatments.
- •10.Known positive for HIV or infectious hepatitis, type A, B or C.
- •11.>grade 2 peripheral neuropathy
- •12.Life expectancy < 3 months
- •13.Concurrent use of steroids (Patients may receive prednisone up to 20 mg/d, or equivalent corticosteroids for concurrent illness or adrenal replacement therapy
研究者
相似试验
进行中（未招募）
不适用
Phase I/II Trial of Lenalidomide in Combination with Vorinostat and Dexamethasone as Therapy in Relapsed or Refractory Patients with Peripheral T-Cell Non-Hodgkin’s Lymphoma (PTCL)EUCTR2008-006919-20-ATArbeitsgemeinschaft medikamentöse Tumortherapie gemeinnützige GmbH
进行中（未招募）
不适用
Phase II study of the combination of Lenalidomide and Alemtuzumab as consolidation in patients who responded to a previus chemotherapeutic regimen administered for relapsed or refractory Chronic Lymphocytic Leukemia (CLL) - len-camCLL patientsMedDRA version: 9.1Level: LLTClassification code 10008958Term: Chronic lymphocytic leukaemiaEUCTR2008-001823-71-ITAssociazione Malattie Sangue ONLUS
终止
1 期
A Phase Ib study of lenalidomide in combination with imatinib for adult patients with chronic myeloid leukaemia in second molecular remissioACTRN12615001169538South Australian Health & Medical Research Institute (SAHMRI)3
进行中（未招募）
不适用
A Phase 1/2 Study of Lenalidomide in combination with Bendamustine (LEBEN) in relapsed and primary refractory Hodgkin Lymphomarelapsed and primary refractory Hodgkin LymphomaMedDRA version: 14.1Level: LLTClassification code 10020328Term: Hodgkin's lymphomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2011-002810-35-ITISTITUTO NAZIONALE PER LO STUDIO E LA CURA DEI TUMORI - FONDAZIONE G. PASCALE
进行中（未招募）
1 期
PHASE II STUDY OF LENALIDOMIDE IN COMBINATION WITH RITUXIMAB (R) FOR THE TREATMENT OF INDOLENT NON FOLLICULAR NON HODGKIN LYMPHOMA - NDHistological proved diagnosis of B-cell CD20-positive non follicular NHL according to REAL/WHO Classification: a. small lymphocytic lymphoma b. lymphoplasmacytic lymphoma/Waldenstrom macroglobulinemia, c. nodal marginal zone lymphoma d. splenic marginal zone lymphomae. e. extranodal non-gastric marginal zone lymphomaMedDRA version: 9.1Level: LLTClassification code 10029463MedDRA version: 9.1Level: LLTClassification code 10003911MedDRA version: 9.1Level: LLTClassification code 10041652MedDRA version: 9.1Level: LLTClassification code 10025345EUCTR2008-001591-80-ITG.I.S.L. - GRUPPO ITALIANO STUDIO LINFOMI