EUCTR2007-002917-38-IT进行中（未招募）不适用
A Randomized Phase IIb Placebo-controlled Study of R-ICE Chemotherapy (Rituximab, Ifosfamide, Carboplatin, and Etoposide) with and without SGN-40 (anti-CD40 humanized monoclonal antibody) for Second-line Treatment of Patients with Diffuse Large B-Cell Lymphoma (DLBCL) - ND
SEATTLE GENETICS INC.0 个研究点目标入组 224 人开始时间: 2007年11月9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
- 224
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. Patient has pathologically confirmed diagnosis of diffuse large B-cell lymphoma (DLBCL), including both de novo and transformed DLBCL and follicular lymphoma, Grade 3b (FL3b).38 Local pathology review is acceptable for determining eligibility. Patients who have achieved a CR since the initial pathological diagnosis must have repeat biopsy for confirmation of disease since relapse. 2. Patient has received at least four cycles of first-line therapy with R-CHOP or equivalent first-line therapy including rituximab, cyclophosphamide, anthracycline or anthracenedione, and steroid with or without additional chemotherapy agent(s). For patients who achieve CR with first-line therapy, maintenance rituximab prior to relapse is allowed. 3. Patient had a best clinical response to first-line therapy of stable disease, partial response, or complete response. 4. Patient currently has at least one site of measurable disease meeting both of the following criteria: Bidimensional measurement with longest axis greater than or equal to 1.5 cm by radiographic imaging. Positive FDG-PET scan at baseline. Local imaging review is acceptable for determining eligibility. 5. A fresh or archived tumor specimen is available for central review to confirm diagnosis, assess expression levels of CD40 and other B cell surface markers (e.g., CD79a, CD19, CD20) on malignant tumor cells, perform immunohistochemical studies to determine DLBCL subtype and/or for gene expression profiling by cDNA microarray analysis. 6. Patient has completed first-line therapy at least four weeks prior to the date of randomization. 7. Patient has an Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to 2. 8. Patient is at least 18 years old and no more than 75 years old. 9. Patient has the following required baseline laboratory data (eligibility can be based on local lab results): Platelet count greater than or equal to 75,000/mm3. Absolute neutrophil count (ANC) greater than or equal to 1,000/mm3 (may be maintained by growth factors). Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) less than or equal to 2.5 times upper limit of normal (ULN). Total serum bilirubin level less than or equal to 1.5 times ULN. Serum creatinine less than or equal to 1.5 times ULN. 10. If a female of childbearing potential, the patient has a negative urine pregnancy test result (sensitivity at least 50 mIU/mL) within three days prior to the first dose of Investigational Drug or on Day 2, prior to first dose. (Females of non-childbearing potential are those who are postmenopausal greater than one year or who have had a bilateral tubal ligation or hysterectomy) 11. If female of childbearing potential or a male patient, patient agrees to use an effective contraceptive method from the time of informed consent, during the course of the study, and for six months following the last dose of Investigational Drug. 12. Patient is available for periodic blood sampling, study-related assessments, and management of toxicity at the treating institution. 13. Patient or their legally authorized representative understands and voluntarily signs the written informed consent prior to any study-specific procedures. A copy of the signed informed consent form will be retained by the treating institution.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64
排除标准
- •1. Patient has a history or clinical evidence of leptomeningeal or central nervous system (CNS) lymphoma. 2. Patient has received any therapy for relapsed or progressive disease except for local radiation, steroids, or single-agent rituximab (less than or equal to four infusions). 3. Patient has a documented history of a cerebral vascular event (stroke or transient ischemic attack) or myocardial infarction within six months of screening. 4. Patient has received a hematopoietic stem cell transplant. 5. Patient has been previously treated with an anti-CD40 mAb or any therapeutic radiolabeled antibody. 6. Patient has had major surgery within four weeks prior to randomization. 7. Patient has a known hypersensitivity or anaphylactic reaction to any component of the planned study treatment. 1. Patient has a history or clinical evidence of leptomeningeal or central nervous system (CNS) lymphoma. 2. Patient has received any therapy for relapsed or progressive disease except for local radiation, steroids, or single-agent rituximab (less than or equal to four infusions). 3. Patient has a documented history of a cerebral vascular event (stroke or transient ischemic attack) or myocardial infarction within six months of screening. 4. Patient has received a hematopoietic stem cell transplant. 5. Patient has been previously treated with an anti-CD40 mAb or any therapeutic radiolabeled antibody. 6. Patient has had major surgery within four weeks prior to randomization. 7. Patient has a known hypersensitivity or anaphylactic reaction to any component of the planned study treatment. 14. Patient has any serious underlying medical condition that would impair their ability to receive or tolerate the planned treatment or subsequent SCT. 15. Patient has been diagnosed with dementia or has altered mental status that would preclude the understanding and/or rendering of informed consent.
研究者
相似试验
进行中（未招募）
不适用
A study for Subjects with Advanced Non-Small Cell Lung Cancer cured with either Tamibarotene or placebo plus Paclitaxel and Carboplatin as First Line Treatment.Advanced Non-Small Cell Lung CancerMedDRA version: 14.1Level: LLTClassification code 10025054Term: Lung cancer non-small cell stage IIIBSystem Organ Class: 100000004864MedDRA version: 14.1Level: LLTClassification code 10025055Term: Lung cancer non-small cell stage IVSystem Organ Class: 100000004864EUCTR2011-004982-33-BGCytRx Corporation140
招募中
2 期
A Phase 2b study with study drug and carboplatin and paclitaxel for Subjects with Advanced Non-Small Cell Lung CancerCTRI/2012/02/002410Daniel Levitt140
进行中（未招募）
1 期
A Randomised Placebo-Controlled Phase II Study of Continuous Maintenance Treatment with BIBF 1120 Following Chemotherapy in Patients with Relapsed Ovarian Cancer -EUCTR2005-002427-14-GBBoehringer Ingelheim Ltd89
进行中（未招募）
不适用
A Randomised, Phase IIb Placebo-controlled Study of R-ICE Chemotherapy (Rituximab, Isofosfamide, Carboplatin, and Etoposide) with and without SGN-40 (anti-CD40 humanized monoclonal antibody) for Second-line Treatment of Patients with Diffuse Large B-Cell Lymphoma (DLBCL) - SeaGen MARINER trialEUCTR2007-002917-38-HUSeattle Genetics, Inc.224
进行中（未招募）
不适用
A Randomised, Phase IIb Placebo-controlled Study of R-ICE Chemotherapy (Rituximab, Isofosfamide, Carboplatin, and Etoposide) with and without SGN-40 (anti-CD40 humanized monoclonal antibody) for Second-line Treatment of Patients with Diffuse Large B-Cell Lymphoma (DLBCL) - SeaGen MARINER trialDiffuse Large B-cell LymphomaMedDRA version: 9.1Level: LLTClassification code 10012818Term: Diffuse large B-cell lymphomaEUCTR2007-002917-38-DESeattle Genetics, Inc.224