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1月6日最近更新: 2018年8月20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

•1.Adults with documented diagnosis of CLL based on the modified IWCLL updated NCI-WG guidelines [Hallek, 2008]
•2.At least PR according to the revised 2008 NCI-WG CLL criteria, within 3 months of the response assessment, after the last dose 2nd/3rd line treatment.
•3.The anti-leukemic treatment before study entry should have been at least 3 months or 3 cycles of polychemotherapy (e.g. CVP), fludarabine-containing chemotherapy or immunochemotherapy.
•4.ECOG Performance Status of 0-2
•5.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 of last anti-leukemic therapy [Hallek, 2008] NOTE: Subjects refractory to rituximab therapy as last therapy are permitted
•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 and medical monitor 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 and medical monitor 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 and medical monitor 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 or GSK medical monitor 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)
•Alanine Aminotransferase (ALT) > 2.5 times upper normal limit (unless due to liver involvement of CLL or Gilbert's syndrome)
•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 OR participation in any other

研究者

发起方

ovartis Pharma Services AG

相似试验

进行中（未招募）

1 期

Study of a new drug combination to treat LeukemiaChronic Lymphocytic LeukaemiaMedDRA version: 18.1Level: LLTClassification code 10008976Term: Chronic lymphocytic leukemiaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 18.1Level: SOCClassification code 10029104Term: Neoplasms benign, malignant and unspecified (incl cysts and polyps)System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 18.1Level: HLGTClassification code 10024324Term: LeukaemiasSystem Organ Class: 10005329 - Blood and lymphatic system disordersMedDRA version: 18.1Level: SOCClassification code 10005329Term: Blood and lymphatic system disordersSystem Organ Class: 10005329 - Blood and lymphatic system disordersMedDRA version: 18.1Level: HLTClassification code 10024295Term: Leukaemias chronic lymphocyticSystem Organ Class: 10005329 - Blood and lymphatic system disordersMedDRA version: 18.1Level: PTClassification code 10008959Term: Chronic lymphocytic leukaemia (in remission)System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)

EUCTR2008-004932-19-SEovartis Pharma Services AG444

进行中（未招募）

1 期

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 therapyEnsayo fase III, abierto, aleatorizado y multicéntrico de tratamiento de mantenimiento con ofatumumab frente a no tratamiento adicional en pacientes con leucemia linfocítica crónica (LLC) en recaída que han respondido al tratamiento de inducció

EUCTR2009-012518-39-ESGlaxoSmithKline S.A532

进行中（未招募）

1 期

EUCTR2008-004932-19-BEovartis Pharma Services AG

进行中（未招募）

1 期

Study of a new drug combination to treat LeukemiaChronic Lymphocytic LeukaemiaMedDRA version: 19.0Level: LLTClassification code 10008976Term: Chronic lymphocytic leukemiaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 19.0Level: SOCClassification code 10029104Term: Neoplasms benign, malignant and unspecified (incl cysts and polyps)System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 19.0Level: HLGTClassification code 10024324Term: LeukaemiasSystem Organ Class: 10005329 - Blood and lymphatic system disordersMedDRA version: 19.0Level: SOCClassification code 10005329Term: Blood and lymphatic system disordersSystem Organ Class: 10005329 - Blood and lymphatic system disordersMedDRA version: 19.0Level: HLTClassification code 10024295Term: Leukaemias chronic lymphocyticSystem Organ Class: 10005329 - Blood and lymphatic system disordersMedDRA version: 19.0Level: PTClassification code 10008959Term: Chronic lymphocytic leukaemia (in remission)System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)

EUCTR2008-004932-19-GBovartis Pharma Services AG

进行中（未招募）

1 期

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. - NDSubjects who are in CR or PR after 1 or 2 treatments for relapsed CLLMedDRA version: 12.1Level: LLTClassification code 10008959Term: Chronic lymphocytic leukaemia (in remission)

EUCTR2009-012518-39-ITGlaxoSmithKline Research and Development532