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 Limited0 个研究点目标入组 80 人2012年1月26日

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注册库

who.int

开始日期

2012年1月26日

结束日期

待定

最后更新

9年前

研究类型

Interventional clinical trial of medicinal product

性别

All

发起方

•Subjects eligible for enrolment in the study must meet all of the following criteria:
•1\. A diagnosis of CLL defined by:
•a. A circulating B\-lymphocyte count of \=5,000/µL at study entry or at any time in the past.
•b. 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 the IWCLL updated NCI\-WG guidelines \[Hallek 2008], defined by presence of at least any one of the following conditions:
•Evidence of progressive marrow failure as manifested by development or worsening of anaemia and/or thrombocytopenia.
•Massive (i.e. at least 6 cm below the left costal margin) or progressive or symptomatic splenomegaly.
•Massive nodes (i.e. at least 10 cm in longest diameter) 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 lymphocyte counts of less than 30x109/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 (e.g., infections) should be excluded.

•Subjects meeting any of the following criteria must not be enrolled in the study:
•1\. Refractory CLL: defined as treatment failure (failure to achieve a CR or PR) or disease progression within 6 months of the last anti\-CLL therapy \[Hallek, 2008].
•2\. Previous autologous or allogeneic stem cell transplantation.
•3\. Active autoimmune hemolytic anaemia (AIHA) and idiopathic thrombocytopenic purpura (ITP) requiring corticosteroid therapy \>25 mg prednisone (or equivalent) or chemotherapy.
•4\. Known transformation of CLL (e.g. Richter’s).
•5\. Known central nervous system involvement by CLL.
•6\. Screening laboratory values:
•a. Platelets \< 100 x 109/L (unless due to CLL involvement of the bone marrow).
•b. Neutrophils \< 1\.5 x 109/L (unless due to CLL involvement of the bone marrow).
•c. Serum creatinine \> 1\.5 times the upper limit of normal (ULN); subjects with a serum creatinine \> 1\.5 ULN will be eligible if the calculated creatinine clearance \[Cockcroft, 1976] is \= 30 mL/min.