CTRI/2019/04/018546招募中2 期
Phase 2 Study To Evaluate The Efficacy Of Lenalidomide Maintenance In Primary CNS Lymphoma. - PRoCLAIM
Tata Memorial Center0 个研究点目标入组 0 人开始时间: 待定最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
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
入选标准
- •1.Patients with histologically proven PCNSL
- •2.Received methotrexate based induction therapy
- •3.Radiological Complete Remission, or unconfirmed complete remission (uCR)
- •4.Received consolidation therapy after achieving CR
- •5.Age > 18 years
- •6.PS <=2 after the completion of consolidation therapy
- •7.Adequate bone marrow function with absolute leukocytes > 2000/mm3, neutrophil count (ANC) > 1000/mm3, haemoglobin > 8 g/dl and platelets > 100 000/mm3
- •8.Adequate liver function with Serum SGOT/AST or SGPT/ALT < 3.0 X Upper Limit of Normal ULN ; bilirubin < 1.5 X LNS
- •9.Creatinineclearance >30 ml/min. Patients with calculated creatinine clearance between 30 and 60ml/min lenalidomide dose will be adjusted as follows (10mg once daily)
- •10.Able to take aspirin (75 mg) daily as prophylactic anticoagulation (patients intolerant to ASA may use warfarin or low molecular weight heparin).
- •11.Able to understand the teratogenicity
- •12.Men and women of child bearing age should agree to use reliable contraception
- •13.Neuropathy of >= grade 2 severity
- •14.Able to understand and sign inform consent
排除标准
- •1.HIV infection
- •2.Prior history of organ transplantation or other cause of severe immunodeficiency
- •3.History of heart disease and/or impaired cardiac function (ECG QTc >450 msec, congenital long qt syndrome, history of ventricular tachyarrhythmia, ventricular fibrillation, congestive heart failure nyha iii/iv, uncontrolled hypertension)
- •4.Pregnancy or breast feeding
- •5.Hypersensitivity to lenalidomide
- •6.Crcl <30ml/min
- •7.Patient at high risk for deep vein thrombosis not willing to take DVT prophylaxis
- •8.Active hepatitis B or C
- •9.Prior history of malignancies other than lymphoma within 3 years
研究者
相似试验
进行中（未招募）
1 期
Phase II study evaluating the efficacy of Lenalidomide in association with Rituximab in refractory or relapse of primary central nervous system lymphomaPrimary central nervous system or Intra ocular lymphoma in relapse or refractory to previous treatmentMedDRA version: 14.1Level: LLTClassification code 10051811Term: Cerebral lymphomaSystem Organ Class: 100000004864EUCTR2012-003786-17-FRINSTITUT CURIE45
已完成
不适用
To investigate the efficacy and safety of lenalidomide and dexamethasone for elderly or frail patients with relapsed/refractory multiple myelomaMultiple MyelomaJPRN-UMIN000008576Iwate Myeloma treatment Study Group53
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
Phase II Study of the Adjunctive Use of Lenalidomide in Patients Undergoing Reduced Intensity Conditioning Allogeneic Transplantation for Multiple Myeloma - Post Transplant Lenalidomide for Multiple Myeloma (Version 1)MedDRA version: 16.1Level: LLTClassification code 10028228Term: Multiple myelomaSystem Organ Class: 100000004864Multiple MyelomaEUCTR2009-012033-30-GBniversity Hospitals Birmingham NHS Foundation Trust40
进行中（未招募）
不适用
A randomised study to test the effectiveness of LEnalidomide plus rituximab, GEmcitabine and methylprednisolone (LR-GEM) in comparison to rituximab, gemcitabine, methylprednisolone and cisplatiN (R-GEM-P) in treatment of Diffuse Large B-cell lymphoma (DLBCL) for the second time (when it has relapsed or grown despite the first treatment)EUCTR2012-002620-32-GBThe Royal Marsden NHS Foundation Trust92