A phase III, open label, randomized, multicenter trial of ofatumumab maintenance treatment versus no further treatment in subjects with relapsed chronic lymphocytic leukemia (CLL) who have responded to induction therapy

ovartis Pharma Services AG0 个研究点目标入组 532 人开始时间: 2010年3月10日最近更新: 2018年7月23日

适应症

试验速览

阶段: 1 期
状态: 进行中（未招募）
发起方: ovartis Pharma Services AG
入组人数: 532

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

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

•Subjects eligible for enrollment in the study must meet all of the following criteria:
•Adults with documented diagnosis of CLL based on the modified IWCLL updated NCIWG guidelines
•1. At least PR according to the revised 2008 NCI-WG CLL criteria within 3 months of the response assessment after the last dose of 2nd/3rd line treatment
•2. The anti-leukemic treatment before study entry should have been for at least 3 months or 3 cycles
•3. ECOG Performance Status of 0-2
•4. 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 155
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 377

排除标准

•1. Known primary or secondary fludarabine-refractory subjects, defined as treatment failure (failure to achieve a CR or PR) or disease progression within 6 months
•2. Prior maintenance therapy
•3. Known transformation of CLL (e.g. Richter’s transformation), prolymphocytic leukemia (PLL), or CNS involvement of CLL
•4. Active Autoimmune Hemolytic Anemia (AIHA) requiring treatment except if in the opinion of the investigator it is thought not to affect the subject’s safety, the conduct of the study or the interpretation of the data
•5. Previous autologous or allogeneic stem cell transplantation
•6. 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 Hepatitis B or C (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 HBV DNA test will be performed and if positive the subject will be excluded*.)
•7. 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 tumor was successfully treated with curative intent at least 2 years prior to trial entry except if in the opinion of the investigator it is thought not to affect the subject’s safety, the conduct of the study or the interpretation of the data
•8. Clinically significant cardiac disease including unstable angina, acute myocardial infarction within 6 months prior to screening, congestive heart failure, and arrhythmia requiring therapy, with the exception of extra systoles or minor conduction abnormalities except if in the opinion of the investigator it is thought not to affect the subject’s safety, the conduct of the study or the interpretation of the data
•9. History of significant cerebrovascular disease or event with symptoms or sequelae
•10. Significant concurrent, uncontrolled medical condition that in the opinion of the investigator contraindicates participation in this study
•11. Other anti-leukemic use of medications including glucocorticoids
•12. Known HIV positive
•13. Screening laboratory values:
•Platelets<50 x 10^9/L
•Neutrophils<1.0 x 10^9/L
•Creatinine > 1.5 times upper normal limit (unless normal creatinine clearance)
•Total bilirubin > 1.5 times upper normal limit (unless due to liver involvement of CLL or Gilbert’s syndrome)
•Alanine Aminotransferase (ALT) > 2.5 times upper normal limit (unless due to liver involvement of CLL)
•Alkaline phosphatase > 2.5 times upper normal limit
•14. Known or suspected hypersensitivity to ofatumumab that in the opinion of the investigator or medical monitor contraindicates study participation
•15. Subjects who have received treatment with any non-marketed drug substance or experimental therapy within 5-terminal half-lives or 4 weeks whichever is longer prior to first dose of study medication or currently participating in any other interventional clinical study
•Note: Participation in any other interventional clinical study after disease progression during post PD follow-up is permitted.
•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 ofa

研究者

发起方

ovartis Pharma Services AG

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