ACTRN12622000207718招募中2 期
An ALLG phase II study of CHOP And Tislelizumab in elderly patients with Hodgkin Lymphoma - Australasian Leukaemia and Lymphoma Group (ALLG) HD12
Australasian Leukaemia and Lymphoma Group0 个研究点目标入组 35 人开始时间: 2022年2月7日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 35
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
入排标准
- 年龄范围
- 61 Years 至 o limit（—）
- 性别
- All
入选标准
- •1.Histologically confirmed diagnosis of classical HL according to the current World Health Organisation (WHO). Diagnosis must be made on a core or excision biopsy of a suitable target lesion.
- •2.Aged 61 years or older
- •3.Clinical stage IIA (unfavourable as per German Hodgkin Study Group (GHSG) criteria) to IVB
- •4.Has provided written informed consent
- •5.Life expectancy at least 3 months
- •6.Men who are sexually active with women of child-bearing potential must use any highly effective contraceptive method during the study (failure rate less than 1% per year) and for a period of 120 days after the last dose of therapy
- •7.PET-CT avid disease at baseline.
- •8.Adequate haematological, renal, hepatic and cardiac function at Screening as defined by:
- •a.ANC (segs + bands) equal to or greater than 1.0 x 10^9/L
- •b.Platelet count equal to or greater than 75 x 10^9/L (or 50 if bone marrow is involved)
- •c.Total bilirubin equal to or less than 1.5 x ULN (unless rise in bilirubin is due to Gilbert’s syndrome or of non-hepatic origin
- •d.ALT and AST equal to or less than 3 x ULN
- •e.Creatinine clearance equal to or greater than 30ml / min / 1.73m2
- •f.LVEF within institutional normal limits (determined either by echocardiography or gated heart pool scan).
- •9.An ECOG performance status score of 0 or 1 at Screening
排除标准
- •1.Central nervous system involvement
- •2.Requirement of urgent treatment due to life threatening complications of the disease.
- •3.Immunosuppressive therapy within the last 2 months, apart from inhaled or topical corticosteroids or systemic corticosteroids at low doses (equal to or greater than 10mg prednisone per day or equivalent)
- •4.Has active auto-immune disease that has required systemic treatment in the prior 2 years with immunosuppressive agents. Replacement therapy such as thyroxine, insulin or physiological steroid replacement for adrenal or pituitary insufficiency is not considered a form of systemic therapy, and hence patients on these therapies are allowed.
- •5.History of inflammatory bowel disease or pneumonitis
- •6.Prior treatments with chemotherapy or radiotherapy within 15 days prior to registration.
- •7.Prior anthracycline use equivalent to greater than 150mg/m2 of doxorubicin.
- •8.History of malignancy during the past 2 years except for locally curable cancers, that have had curative surgical treatment. Examples are:
- •-Treated carcinoma in situ at any site (e.g. cervix, breast)
- •Adequately treated non melanoma skin cancer
- •-Superficial bladder cancer, adequately treated with surgical/cauterisation. (BCG treatment is excluded)
- •-Untreated chronic lymphocytic leukaemia with a less than 50% rise in the lymphocyte count in the preceding 6 months
- •-Low risk early-stage prostate adenocarcinoma (Gleason score equal to or less than 6).
- •-Pre-malignant lesions (e.g. monoclonal gammopathy of uncertain significance, monoclonal B cell lymphocytosis) are allowed.
- •9.Uncontrolled active infection (defined as an infection that requires intravenous anti-microbial treatment,) at the time of first dose of therapy.
研究者
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