EUCTR2010-019575-29-GB进行中（未招募）1 期
Phase II trial of ofatumumab, dexamethasone and lenalidomide for high-risk CLL (NCRI CLL210) - CLL210 (OfaDexRev)
niversity of Liverpool0 个研究点目标入组 64 人开始时间: 2011年2月16日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 64
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
入选标准
- •CLL/SLL requiring treatment by IWCLL 2008 criteria. At least one of the following criteria should be met:
- •oEvidence of progressive marrow failure as manifested by the development of, or worsening of, anaemia and/or thrombocytopenia.
- •oMassive (i.e. at least 6cm below the left costal margin) or progressive or symptomatic splenomegaly.
- •oMassive (i.e. at least 10cm in longest diameter) or progressive or symptomatic lymphadenopathy.
- •oProgressive lymphocytosis with an increase of more than 50% over a 2-month period or lymphocyte doubling time (LDT) of less than 6 months from a baseline value of at least 30x10^9/l and not due to causes other than CLL.
- •oConstitutional symptoms defined as at least 10% unintentional weight loss within the previous 6 months, significant fatigue preventing usual activities, or fever of at least 38°C for at least 2 weeks or night sweats for at least one month in the absence of infection.
- •High risk CLL/SLL defined by at least one of the following criteria:
- •oTP53 deletion or mutation affecting at least 20% of CLL cells
- •oResistant (SD/PD) to fludarabine-containing combination therapy
- •oRelapse within 12 months of responding to fludarabine-containing combination therapy
- •No prior treatment with ofatumumab or lenalidomide
- •CLL not known to be resistant to glucocorticoids
- •No more than 3 previous treatment episodes for CLL
- •WHO performance status 0-2
- •Aged at least 18 years
- •Written Informed Consent
- •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 0
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 0
排除标准
- •Neutrophil count less than 0.5x10^9/l or platelet count less than 25x10^9/l
- •Uncontrolled auto-immune haemolytic anaemia or thrombocytopenia
- •Total bilirubin >1.5 times upper normal limit (unless due to involvement of liver or a known history of Gilbert’s disease) or ALT >2.5 times upper normal limit (unless due to disease involvement of liver)
- •Active infection
- •Active gastritis or peptic ulcer disease
- •Uncontrolled diabetes mellitus or hypertension
- •History of recurrent thromboembolism
- •Seropositivity for HIV, HCV or HBV (surface antigen)
- •Renal impairment (eGFR less than 30ml/min)
- •Hepatic impairment (serum bilirubin more than twice the upper limit of normal unless due to Gilbert’s syndrome or CLL)
- •Concurrent treatment with glucocorticoids equivalent to more than prednisolone 20mg od
- •Presence or history of CNS disease (either CNS lymphoma or leukaemic meningitis)
- •History of Richter transformation
- •Concomitant malignancies except adequately treated localised non-melanoma skin cancers and other in-situ cancers, or invasive cancers that have been in remission for a period of time considered by the local investigator to pose a negligible risk of relapse during the period of the trial.
- •Major surgery within 28 days prior to registration
- •Any serious underlying medical or psychological conditions, which could impair the ability of the patient to participate in the trial or compromise ability to give informed consent
- •Treatment within a clinical trial within 30 days prior to trial entry
- •Adult patient under tutelage (not competent to sign informed consent)
- •Pregnant or lactating women
- •Patients unwilling or not able to adhere to the Lenalidomide Pregnancy Prevention Plan
- •Women taking the oral contraceptive pill within 4 weeks of study registration owing to an increased risk of thromboembolism
- •Women of childbearing potential, including women whose last menstrual period was less than 24 months prior to screening, unable or unwilling to use adequate contraception from study start to 28 days after the last dose of protocol therapy. Adequate contraception is defined as hormonal birth control, intrauterine device, double barrier method or total abstinence. Male subjects unable or unwilling to use adequate contraception methods from study start to one year after the last dose of protocol therapy
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