KCT0003053已完成未知
Prospective, multicenter, open-labeled, phase I/II study of the efficacy and safety of copanlisib (BAY 80-6946) and gemcitabine combination in patients with relapsed/refractory peripheral T-cell or NK/T-cell lymphomas
Chonnam National University Hospital Hwasun Hospital0 个研究点目标入组 28 人开始时间: 待定最近更新:
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 28
研究概览
简要总结
Copanrisib and gemcitabine combination therapy is a safe and effective treatment option for patients with relapsed/refractory peripheral T-cell lymphoma.
研究设计
- 研究类型
- Interventional Study
入排标准
- 年龄范围
- 19(Year) 至 o Limit（—）
- 性别
- All
入选标准
- •Histologically confirmed relapsed or refractory PTCL or NK/T-cell lymphomas, excluding primary cutaneous T-cell lymphoma, and Sezary syndrome based o WHO classification
- •:relapsed or refractory disease are defined as disease relapse in patients achieved complete response from prior combination chemotherapy or partial response or less from prior combination chemotherapy
- •Age = 19
- •ECOG performance status = 2
- •At least one bi-dimensional measurable lesion, which is defined as longest diameter of lymph node > 1.5cm or extranodal lesion > 1.0cm according to the Lugano classification
- •Laboratory values
- •-Serum Cr < 1.5mg/dL or CrCl > 50mL/min
- •-Transminase(AST/ALT) <2.5 x upper normal value (or <5xULN in the pressence of the liver)
- •-Bilirubin <1.5 x upper normal value (or < 3 xULN in the presence of lymphoma involvement of the liver or Gilbert syndrome)
- •-PT(INR) = 1.5 x ULN and aPTT = 1.5 x ULN
- •-Lipase = 1.5 x ULN
- •-Hematologic functions; absolute neutrophil count (ANC) = 1,500/ul and platelet count = 75,000/ul, hemoglobin = 8 g/dL
- •Left ventricular ejection fraction (LVEF) = the lower limit of normal for the institution
- •Women of childbearing potential and men must agree to use adequate contraception when sexually active
- •-This applies since signing fo the informed consent form untill at least 3 months after the last study drug administration
- •-Adequate contraception is defined in the study as highly dffective birth control method (failure rate of less than 1%) e.g. intrauterine device(IUD), intrauterine hormone-releasing system(IUS), bilateral tubal occlusion, vasectomized partner, and sexual abstinence. The use of condoms by male patients is required unless the famale partne is permanently sterile
- •Written informed consent
排除标准
- •B-cell NHL, or primary cutaneous T-cell lymphoma and Sezary syndrome
- •Patients who had previous history of lymphoma involvement of the CNS. However, patients who have had only prophylactic chemotherapyp against CNS disease are eligible
- •History ofo previous gemcitabine or PI3K inhibitor therapy
- •Type I or II diabetes mellitus with HbA1c > 8.5% at screening
- •History of chronic hepatitis B; subjects positive for HBsAg will be excluded from this study. However, subjects with HBcAb will be eligible if they are negative for HBV DNA quantification
- •History of chronic hepatitis C; subjects positive for HCV IgG will be eligible if they are negative for HCV-RNA quantification
- •Known history of hyman immynodeficiency virus(HIV) infection
- •History or concurrent condition of intestitial lung disease of any severity and/or severely inpaired lung funcion
- •Any other malignancies within the pase 3 years except curatively treated basal cell carcinoma of the skin, carcinoma in situ of the uterine cervis, or papillary carcinoma of the thyriod
- •Other serious illness or medical conditions
- •-Congestive heart failure > NYHA class 2
- •-Unstable angina or new-onset angina within the last 3 months; Myocardial infarction within 6 months prior to study entry
- •-History of significant neurological or psychiatric disorders including dementia or seizure
- •-Uncontrolled hypertension despite optimal medical management(per investigator's opinion)
- •-Arterial or venous thrombotic or embolic events such as cerebrovascular accident (including transient ischemic attacks), deep vein thrombosis or pulmonary embolism within 6 months before start of study treatment
- •-Non-healing wound, uncer, or bone fracture
- •-Actibe uncontrolled infection (viral, bacterial, or fungal infection)
- •-Patients with ebidence or history of bleeding diathesis. Any hemorrhage or bleening event = grage 3 within 4 weeks of start of study medication
- •-Proteinuria estimated by urine protein/creatinine ratio > 3.5 on a random urine sample
- •-Concurrent diagnosis of pheochromocytoma
- •Other previous or concurrent treatments
- •-Ongoing immunosuppressive therapy
- •-Radiotherapy or immune-/chemotherapy less than 4 weeks before start of treatment
- •-Radioimmunotherapy or autologous transplant less than 3 months before start of treatment
- •-Myeloid growth factors within 14 days prior th treatment start
- •-Blood or platelet transfusion within 7 days prior to treatment start
- •-Systemic continuous corticosteroid therapy at a daily dose higher than 15mg prednisone or equivalent
- •-History of having received an allogeneic bone marrow or organ trasplant
- •-Major surgical procedure or significant trauma injury within 28days before start of study medication, open biopsy within 7days before start of study treatment
- •-Anti-arrhythmic therapy(beta-blockers or digoxin are permitted)
- •-Use of CYP3A4 inhibitor or inducer
- •Pregnant or lactating women, women of childbearing potential not remploying adequate contraception
- •Concomitant administration of any other experimental drugs under investigation
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