EUCTR2008-004932-19-BE进行中（未招募）1 期
A phase III, open label, randomized, multicenter trial of Ofatumumab added to Chlorambucil vs. Chlorambucil Monotherapy in previously untreated patients with Chronic Lymphocytic Leukemia
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
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.Diagnosis of CLL defined by:
- •Circulating lymphocytes =5,000/µL
- •Flow cytometry confirmation of immunophenotype with CD5, CD19, CD20,
- •CD23, CD79b, and surface Ig prior to Visit 2
- •Lymphocytosis with less than 5,000/µL B lymphocytes displaying the CLLimmunophenotype but in the absence of other features of a B-cell
- •lymphoproliferate disorder (lymphadenopathy, organomegaly, cytopenias,
- •disease-related symptoms) is defined as monoclonal B-lymphocytosis (MBL), not
- •2.Considered inappropriate for fludarabine-based therapy, for reasons that include, but not limited to, advanced age or presence of co-morbidities
- •3. Active disease and indication for treatment based on modified NCI-WG guidelines [Hallek, 2008] defined by presenting at least any one of the following conditions:
- •Evidence of progressive marrow failure as manifested by development or worsening of anemia and/or thrombocytopenia
- •Massive (i.e. > 6cm below the left costal margin) or progressive or symptomatic splenomegaly
- •Massive nodes (i.e. > 10cm in longest diameter) or progressive or symptomatic lymphadenopathy
- •Progressive lymphocytosis with an increase of more than 50% over a two month period or an lymphocyte doubling time of less than 6 months. In patients with initial blood lymphocyte counts of less than 30x10^9/L, lymphocyte doubling time should not be used as a single parameter to define a treatment indication. In addition, factors contributing to lymphocytosis or lymphadenopathy other than CLL (eg, infections) should be excluded.
- •A minimum of any one of the following disease-related symptoms must be present:
- •a) Unintentional Weight loss =10% within the previous six months
- •b) Fevers > 100.5oF (38.0oC) for = 2 weeks without evidence of infection
- •c) Night sweats for more than 1 month without evidence of infection
- •4.Not been previously treated for CLL (prior autoimmune hemolytic anemia treatment permitted)
- •5.ECOG Performance Status of 0-2
- •6.Life expectancy of at least 6 months
- •7.Age = 18 years
- •8.Signed written informed consent prior to performing any study-specific procedures
- •French subjects: In France, a subject will be eligible for inclusion in this study only if either affiliated to or a beneficiary of a social security category.
- •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 148
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 269
排除标准
- •1.Prior immuno- or chemotherapy for CLL or small lymphocytic lymphoma (SLL) with any agent except corticosteroids used to treat autoimmune hemolytic anemia
- •2.Previous autologous or allogeneic stem cell transplantation
- •3.Active autoimmune hemolytic anemia (AIHA) requiring corticosteroid therapy > 100mg equivalent to hydrocortisone, or chemotherapy
- •4.Known transformation of CLL (e.g. Richter)
- •5.Known CNS involvement of CLL
- •6.Chronic or current 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 Hepatitis C.
- •7.Other past or current malignancy. Subjects who have been free of malignancy for at least 5 years, or have a history of completely resected non-melanoma skin cancer, or successfully treated in situ carcinoma are eligible.
- •8.Clinically significant cardiac disease including unstable angina, acute myocardial infarction within 6 months prior to Visit 1, congestive heart failure, and arrhythmia requiring therapy, with the exception of extra systoles or minor conduction abnormalities
- •9.History of significant cerebrovascular disease or event with significant symptoms or sequelae
- •10.Glucocorticoid use, unless given in doses = 100mg/day hydrocortisone (or equivalent dose of other glucocorticoid) for <7 days for exacerbations other than CLL (e.g. asthma)
- •11.Known HIV positive
- •12.Positive serology for Hepatitis B (HB) defined as a positive test for HBsAg. In addition, if negative for HBsAg but HBcAb positive (regardless of HBsAb status), a HB 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 (see Section 6.3.4). Prophylactic antiviral therapy may be initiated at the discretion of the investigator.
- •13.Screening laboratory values:
- •Creatinine > 2.0 times upper normal limit (unless normal creatinine clearance)
- •Total bilirubin > 2.0 times upper normal limit (unless due to liver involvement of CLL)
- •alanine transaminase (ALT) > 3.0 times upper normal limit (unless due to liver involvement of CLL)
- •14.Previous treatment or known or suspected hypersensitivity to ofatumumab that in the opinion of the investigator or medical monitor is a contraindication to their participation in the present study
- •15.Treatment with any known non-marketed drug substance or experimental therapy within 5 terminal half lives or 4 weeks prior to Visit 1, whichever is longer, treatment with any anti-CD20 monoclonal antibody within 3 months of Visit 1, or participation in any other interventional clinical study. Note: Participation in any other interventional clinical study after disease progression during post PD-followup is permitted.
- •16.Known or suspected inability to comply with study protocol
- •17.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 treatment 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 partner sterilization if male partner is sole p
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