EUCTR2012-001900-39-GB进行中（未招募）1 期
A multicentre randomised phase II clinical trial of Inotuzumab Ozogamicin plus Rituximab and CVP (IO-R-CVP) versus Gemcitabine plus Rituximab and CVP (Gem-R-CVP) for the first line treatment of patients with diffuse large B cell lymphoma who are not suitable for anthracycline containing chemotherapy - INCA
niversity College London0 个研究点目标入组 132 人开始时间: 2012年9月20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
- 132
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
入选标准
- •Inclusion criteria for randomisation:-
- •a. Informed written consent for the trial
- •b. Histologically proven diffuse large B cell lymphoma (DLBCL) according to the current World Health Organisation (WHO) classification including all morphological variants. The B cell nature of the proliferation must be verified by demonstration of CD20 positivity. A concurrent (synchronous) diagnosis of low grade lymphoma (e.g. on bone marrow trephine or presence of both low grade and DLBCL in a lymph node biopsy) or previous diagnosis of low grade lymphoma which hasn’t been treated with a systemic therapy is permitted.
- •c. Bulky Stage IA (lymph node or lymph node mass =10cm in maximum diameter), stage IB, stage II, stage III and stage IV disease
- •d. ECOG performance status 0-2
- •e. Measurable disease
- •f. Age 18 = years
- •g. Adequate contraceptive precautions for all patients of childbearing potential
- •h.History of malignant disease diagnosed at any time in the past with completed radical treatment and the risk of relapsing within the next 5 years is <10%. Patients previously treated should be free of sequelae of treatment which would compromise the delivery of study drugs as compared with other eligible patients. Cases with second malignancy where eligibility is uncertain should be discussed in the first instance with the CTC.
- •i. No previous chemotherapy, radiotherapy or other investigational drug for this indication – previous corticosteroids up to a dose equivalent to prednisolone 1mg/kg/day for up to 14 days are permitted prior to randomisation
- •j. Unsuitable for anthracycline-containing chemotherapy due to impaired cardiac function defined by an ejection fraction of =50%
- •Left ventricle ejection fraction >50% but in the presence of significant co-morbidities (diabetes mellitus, hypertension or ischaemic heart disease) precluding anthracycline-containing chemotherapy as determined by treating physician. Co-morbidities must be documented on the randomisation form and CIRS score recorded
- •k. Adequate bone marrow function (Platelets >100x109/l, WBC >3.0x109/l, Neutrophils >1.5x109/l) at time of study entry unless attributed to bone marrow infiltration by DLBCL
- •l. Life expectancy >3 months
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 10
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 122
排除标准
- •Exclusion criteria for randomisation:-
- •a. Symptomatic central nervous system or meningeal involvement by DLBCL
- •b. Previous diagnosis of low grade lymphoma which has been treated with a systemic therapy
- •c. Non-bulky stage IA disease
- •d. ECOG performance status 3-4
- •e. History of chronic liver disease or suspected alcohol abuse
- •f. Serum bilirubin greater than upper limit of normal unless attributable to Gilberts syndrome or haemolysis
- •g. Alanine and/or aspartate aminotransferase levels (ALT and/or AST) and alkaline phosphatase (ALP) greater than 2.5 times the upper limit of normal
- •h. Glomerular filtration rate (GFR) <30ml/min. GFR calculated by Cockroft-Gault (not eGFR).
- •i. Serological evidence of active hepatitis B or C infection whether acute or chronic (defined as positive anti-HCV serology; positive HBsAg). All positive HBcAb results should also be excluded on safety grounds regardless of HBsAg or HBV DNA status. Antibodies to Hepatitis B surface antigen (anti-HBs) due to a history of past vaccination is acceptable
- •j. Known history of HIV seropositive status
- •k. Medical or psychiatric conditions compromising the patient’s ability to give informed consent
- •l. Women who are pregnant or lactating
- •m. LVEF >50% in the absence of significant co-morbidities that preclude anthracycline use
- •n. Patients with a history of severe allergic/anaphylactic reaction to any humanised monoclonal antibody
- •o. Patients with serious active infection
- •p. Patients with a history of Venoocclusive Disease (VOD) and Sinusoidal Obstructive Syndrome (SOS)
- •q. Patients with a screening of QTcF interval >470msec
研究者
相似试验
进行中（未招募）
1 期
A multicentre randomised phase II clinical trial comparing oxaliplatin (Eloxatin), capecitabine (Xeloda) and pre-operative radiotherapy with or without cetuximab followed by total mesorectal excision for the treatment of patients with magnetic resonance imaging (MRI) defined high risk rectal cancer. - EXPERT-CHigh risk operable rectal adenocarcinomaMedDRA version: 13.1 Level: PT Classification code 10038038 Term: Rectal cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2004-004707-38-GBRoyal Marsden NHS Trust164
已完成
不适用
A multicentre randomised phase II clinical trial comparing oxaliplatin (Eloxatin), capecitabine (Xeloda) and pre-operative radiotherapy with or without cetuximab followed by total mesorectal excision for the treatment of patients with magentic resonance imaging defined high risk rectal cancerRectal cancerCancerISRCTN99828560Royal Marsden NHS Foundation Trust (UK)164
进行中（未招募）
不适用
A multicentre randomised phase II clinical trial comparing oxaliplatin (Eloxatin), capecitabine (Xeloda) and pre-operative radiotherapy with or without cetuximab followed by total mesorectal excision for the treatment of patients with magnetic resonance imaging (MRI) defined poor risk rectal cancer. - EXPERT-CPoor risk operable rectal adenocarcinomaEUCTR2004-004707-38-SEProf David Cunningham164
进行中（未招募）
不适用
A multicentre randomised Phase II clinical trial to demonstrate equivalent pharmacodynamic efficacy and tolerability of two updosing schedules for ALK-Flex SQEUCTR2008-006921-14-DEALK-Abelló Arzneimittel GmbH
尚未招募
不适用
Evaluating the efficacy of radiation therapy compared to surveillance in men with prostate cancer that has returned after surgery and negative Prostate specific membrane antigen positron emission tomography/computed tomography (PSMA PET/CT) scan.Cancer - ProstateProstate cancerACTRN12622001478707The Australian and New Zealand Urogenital and Prostate Cancer Trials Group Ltd100