A Phase II, Multi-centre Study investigating the Safety and Efficacy of Ofatumumab and Bendamustine combination in patients with untreated or relapsed Chronic Lymphocytic Leukaemia (CLL)

GLAXOSMITHKLINE RESEARCH & DEVELOPMENT LTD.0 个研究点目标入组 80 人开始时间: 2012年3月7日最近更新: 2016年4月11日

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试验速览

阶段: 不适用
状态: 进行中（未招募）
发起方: GLAXOSMITHKLINE RESEARCH & DEVELOPMENT LTD.
入组人数: 80

研究概览入排标准研究者记录与标识符相似试验

研究概览

简要总结

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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-A diagnosis of CLL defined by:a circulating B-lymphocyte count of>=5000/uL at study entry or at any time in the past/flow cytometry confirmation of immunophenotype with CD5,CD19,CD20,CD23,CD79b and surface Ig prior to first dose of study treatment 2-active disease and indication for treatment based on IWCLL updated NCI-WG guidelines, defined by presence of at least any one following conditions:-evidence of progressive marrow failure as manifested by development or worsening of anaemia and/or thrombocytopenia - massive (i.e. at least 10cm in longest diameter) or progressive or symptomatic lymphadenopathy - massive (i.e. at least 6cm below the left costal margin) or progressive or symptomatic lymphadenopathy - progressive lymphocytosis with an increase of more than 50% over a two month period or a lymphocyte doubling time of less than 6 months. In subjects with initial blood lymphocytes counts of less than 30x109/L, lymphocytes doubling time should not be used as single parameter to define a treatment indication. in addition, factors contributing to lymphocytosis or lymphoadenopathy other than CLL (e.g. infections) should be excluded - a minimum of any one of the followin disease-related symptoms must be present: a.unintentional weight loss>=10% within the previous 6months. b.fevers>38°V for >=2weeks without evidence of infection; or c.night sweats for more than 1month without evidence of infection. 3. ECOG performance status of 0-2; 4. age>=18years; 5.signed written informed consent from either the subject, or their legally acceptable representative if the subject is incapable of giving their own consent, prior to performing any study-specific tests or procedures; subject enrolled into the previously untreated subject cohort must also meet all the following criteria: 6.no prior treatment for CLL (prior corticosteroid immunosuppression treatment for autoimmune hemolytic anaemia and ITP is permitted) 7. consedered inappropriate for fludarabile-based therapy ofr reasons that include, but are not limited to, advanced age or presence of co-morbidities. subject enrolled into the relapsed subject cohort must also meet the following criteria:8.relapsed CLL:defined as a subject who has received at least one prior CLL therapy and previously achieved a complete or partial remission/response lasting at least 6months
•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 40
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 40

排除标准

•1.Refractory CLL:defined as treatment failure(failure to achieve a CR or PR) or disease progression within 6months of the last antiCLL therapy 2.Previous autologous or allogeneic stem cell transplantation 3.Active AIHA requiring corticosteroid therapy >25mg prednisone(or equivalent)or chemotherapy 4.Known transformation of CLL(e.g. Richter) 5.Known CNS involvement of CLL 6.Screening laboratory values:a.platelets <100x109/L (unless due to CLL involvment of the bone marrow).b.neutrophils<1.5x109/L (unless due to CLL involvment of the bone marrow).c.Serum Creatinine>1.5times the upper limit of normal(ULN);subjects with a serum creatinine<1.5ULN will be elegible if the calculated creatinine clearance is >=30mL/min.d.Total bilirubin >1.5times ULN(unless due to liver involvment by CLL or Gilbert's disease).e.Transaminases >2.5times ULS 7. Chronic or current active infectious disease requiring systemic antibiotics,antifungal or antiviral treatment such as,but not limited to, chronic renal infection,chronic chest infection with bronchiectasis,tuberculosis and active HepatitisC and known HIV disease.All HIV-positive subjects are excluded from this study, regardless or whether they have an AIDS defining disease and/or are on antiviral therapy. 8.Other past or current malignancy (with the exception of basal cell carcinoma of the skin or in situ carcinoma of the cervix or breast) unless the tumour was successfully treated with curative intent at least2years prior to trail entry*9.Clinically significant cardiac disease including unstable angina, acute myocardial infarction within 6months prior to first study treatment,congestive heart failure and arrhythmia requiring therapy,with the exception of extra systoles or minor conduction abnormalities*10.History of significant cerebrovascular disease or event with significant symptoms or sequelae*11.Glucocorticoid use, unless given in doses= 25mg/day prednisone (or equivalent)for<7days for exacerbations other than CLL(e.g. asthma)*12.Positive serology for(HBsAg).In addition,if negative for HBsAg but HBcAb positive, a HBV DNA test will be performed and if positive the subject will be excluded.If HBV DNA is negative,subject may be included but must undergo HBV DNA monitoring at Cycles2,3,4,5,6 depending on the number of cycles administered and during the followup phase at the 3Month and6Month post drug visits.Prophylactic antiviral therapy may be initiated at the discretion of the investigator.Please see Table5 for further details. 13.Known or suspected hypersensitivity to ofatumumab or bendamustine that in the opinion of the investigator is a contraindication to their participation in the present study 14. Treatment with any known non-marketed drug substance or experimental therapy within 5 terminal half lives or 4 weeks prior to first study treatment dose, whichever is longer, or participation in any other interventional clinical study. 15.Known or suspected inability to comply with study protocol 16. Lactating women, women with a positive pregnancy test at Visit 1 or women (of childbearing potential) as well as men with partners of childbearing potential, who are not willing to use adequate contraception from study start through one year following last ofatumumab dose. Adequate contraception is defined as abstinence, oral hormonal birth control, hormonal birth control injections, implants of levonorgestrel, estrogenic vaginal ring, percutaneous contraceptive patches, intrauterine device, and male partne

研究者

发起方

GLAXOSMITHKLINE RESEARCH & DEVELOPMENT LTD.

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