ACTRN12618000028202已完成2 期
A phase 2, open label trial to evaluate safety, tolerability and efficacy of guadecitabine (SGI-110) in patients with T-cell lymphoma
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 20
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Non-randomised trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 o limit（—）
- 性别
- All
入选标准
- •1)Age >18 years old
- •2)ECOG performance status 0-3.
- •3)Histologically confirmed diagnosis of a mature T-cell neoplasm, as defined by the 2016 World Health Organisation (WHO) classification system and including (but not restricted to):
- •a)Anaplastic large cell lymphoma (ALCL), ALK positive or negative
- •b)Angioimmunoblastic T-cell lymphoma (AITL)
- •c)Cutaneous T-cell lymphomas (CTCL) including mycosis fungoides (MF) and Sezary syndrome (SS).
- •d)Enteropathy associated T-cell lymphoma (EATL)
- •e)Hepatosplenic T-cell lymphoma (HSTL)
- •f)Peripheral T-cell lymphoma not otherwise specified (PTCL-NOS)
- •g)T-cell prolymphocytic leukaemia (T-PLL)
- •4)Measurable disease as defined by disease presentation utilising standard response criteria for systemic (Cheson et al, Blood 2014) or cutaneous disease (Olsen et al, J Clin Oncol 2011).
- •a)Subjects with relapsed or refractory disease who are unsuitable for high-dose therapy and/or autologous stem cell transplantation in the opinion of the investigator.
- •b)Subjects with relapsed or refractory disease despite high-dose therapy and/or prior stem cell transplantation.
- •c)Subjects with newly diagnosed and previously untreated disease who are unfit to receive CHOP/CHOP-like therapy or the disease specific standard of care in the opinion of the investigator.
- •6)An interval of at least two weeks since treatment with chemotherapy, immunotherapy or biological therapy prior to enrolment. Corticosteroids up to 20mg per prednisolone equivalent per day are permitted for non-lymphoma indications and autoimmune manifestations of lymphoma (e.g. haemolysis).
- •7)Life expectancy > 3 months.
排除标准
- •1)Prior treatment with guadecitabine or other DNA hypomethylating agent (e.g. azacitidine, decitabine).
- •2)Hypersensitivity to guadecitabine , azacitidine, decitabine or their excipients.
- •3)Second malignancy currently requiring active therapy except:
- •a.Breast or prostate cancer stable on or responding to endocrine therapy.
- •b.Pre-existing or concurrently diagnosed MDS (including chronic myelomonocytic leukaemia), or AML with bone marrow blasts <31%.
- •c.Non-melanomatous skin cancers such as basal or squamous cell carcinomas.
- •4)Patients with known active central nervous system involvement.
- •5)Renal impairment with creatinine clearance (as estimated by the Cockroft-Gault or other medically acceptable formula) <30ml/min.
- •6)Liver cirrhosis / chronic liver disease Child-Pugh B or C; total serum bilirubin >2.5x upper limit of normal (ULN), except for subjects with Gilbert’s syndrome for whom the direct bilirubin is <2.5 ULN.
- •7)Known active human immunodeficiency virus (HIV), hepatitis B virus (HBV), or hepatitis C virus (HCV) infection not controlled on antiviral therapy. Inactive hepatitis carrier status or low viral hepatitis titre on antivirals is permitted.
- •8)Inability to understand and comply with study procedures, or unable to provide written informed consent before any study-specific procedure.
- •9)Refractory congestive heart failure unresponsive to medical treatment; active infection resistant to all antibiotics; or advanced pulmonary disease requiring >2 litres per minute (LPM) oxygen.
- •10)Known illness or condition that, in the opinion of the investigator, predisposes the subject to high risk of noncompliance with the protocol.
- •11)Any uncontrolled intercurrent medical condition or laboratory abnormality, which would in the opinion of the investigator make participation unsafe.
- •12)Women of child-bearing potential must not be pregnant or breastfeeding and must have a negative pregnancy test at screening. Women of child-bearing potential and men with female partners of child-bearing potential must agree to practice 2 highly effective contraceptive measures during the study and for at least 3 months after completing treatment and must agree not to become pregnant or father a child while receiving treatment with guadecitabine and for at least 3 months after completing treatment.
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