KCT0007893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
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 入组人数
- 1
研究概览
简要总结
Copanlisip and gemcitabin combination therapy are safe and effective treatments in patients with recurrent/inactive 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 recurrence or refractory peripheral T-cell or NK/T-cell lymphoma according to WHO classification criteria. Excluding primary skin T-cell lymphoma and Sezary syndrome
- •: Recurrence or non-responsive disease is defined as the recurrence of the disease in a patient who has obtained a complete response from a previous combination of chemotherapy or less than a partial response from a previous combination of chemotherapy
- •Age: ???19 years old
- •ECOG Activity Status 2 2 (Appendix 1)
- •Presence of one or more measurable lesions. Defined as Lymph node longest axis > 1.5 cm or Lymph node external lesion > 1.0 cm according to the Lugano classification (Cheson BD, 2014; Appendix 2).
- •Laboratory inspection figures
- •- Serum Cr < 1.5 mg/dL or CrCl > 50 mL/min
- •- Asparagine acid amino transferase (AST)/alanine amino transferase (ALT) < 2.5 x normal upper limit (provided that there is a liver invasion of lymphoma < 5 x normal upper limit)
- •- Serum bilirubin < 1.5 x normal upper limit (however, if Gilbert syndrome or lymphomas have liver invasion < 3 x normal upper limit)
- •- PT (INR) 1.5 1.5 x normal upper limit, aPTT 1.5 1.5 x normal upper limit
- •- Lipase 1.5 1.5 x normal upper limit
- •- Hematological test results: absolute neutrophil count (ANC) 1,500 1,500/ll, platelet count 75 75,000/ll, hemoglobin 8 8 g/dL
- •Left ventricular ejection fraction ??? Normal lower limit for each organ
- •In the case of women who are likely to be pregnant or men who are likely to be pregnant, they agree to appropriate contraception.
- •- Adequate contraception is defined in such ways as intrauterine device (IUD), intrauterine hormone secretion system (IUS), bilateral ovary ligation, male spouse's vasectomy, and complete abstinence. In addition, in the case of male test subjects, blocking contraception such as condoms is performed regardless of whether the female spouse is permanently infertile. Appropriate contraception is applied from the time of signing the consent form to at least three months after the last administration of the test drug.
- •If you sign a consent form
排除标准
- •B-cell NHL, or primary skin T-cell lymphoma and Sezary syndrome
- •Patients with a history of central nervous system (CNS) invasion of lymphoma. However, patients who received only preventive chemotherapy for central nervous system invasion can be registered
- •Treatment history of conventional gemcitabin or PI3K inhibitors
- •Type 1 or type 2 diabetes with glycated hemoglobin (HbA1C) > 8.5% at the time of screening
- •Chronic hepatitis B history; HBsAg positive will be excluded from this study. However, in the case of HBcAb positive, registration is possible if it is negative in the HBV DNA quantitative test.
- •Chronic hepatitis C history; HCV IgG positive, HCV-RNA quantitative tests can register if negative.
- •Human immunodeficiency virus (HIV) infection history
- •If you have a history of interstitial lung disease, regardless of severity, or if you have severe lung failure.
- •Patients who have developed other malignant tumors within the last three years, except for basal cell carcinoma, cervical epithelial cancer, and thyroid papillary cancer, which have been completely treated for complete recovery purposes
- •Other serious diseases or medical conditions
- •- congestive heart failure > NYHA class 2 (Appendix 3)
- •- Unstable angina within 3 months of study registration or newly developed angina; myocardial infarction within 6 months of study registration
- •- A history of major neurological or psychiatric diseases, including dementia or epilepsy
- •- Hypertension that is not controlled by appropriate medical measures (at the discretion of the research physician in charge of the study)
- •- Cerebrovascular disease (including temporary cerebral ischemia), deep vein thrombosis, or thromboembolism of arteries or veins within 6 months of study registration
- •- an unrecoverable wound, ulcer, or bone fracture
- •- Uncontrolled active infection (viral, bacterial, fungal)
- •- A symptomatic hemorrhagic disease or a history thereof. Bleeding power above 3 degrees within 4 weeks prior to administration of the test drug.
- •- Urine protein/creatinine ratio > 3.5 proteinuria on urine test
- •- Simultaneous diagnosis of pheochromocytoma
- •other previous or present treatments
- •- If you are currently undergoing immunosuppressive therapy
- •- If radiation therapy or immuno/cancer treatment is received within 4 weeks prior to administration of the test drug
- •- If radioimmunotherapy or autohematopoietic stem cell transplantation is performed within 3 months prior to administration of the test drug
- •- If a white blood cell production promoter is administered within 14 days before administration of the test drug,
- •- If red blood cell or platelet transfusion is received within 7 days prior to administration of the test drug
- •- If prednisone (greater than 15 mg per day) or equivalent doses of systemic corticosteroids are required to be sustained
- •- If you have previously received a homologous hematopoietic stem cell transplant or other solid organ transplant,
- •- Major surgery or severe trauma within 28 days before administration of the test drug. Open tissue biopsy within 7 days before taking the test drug
- •- Anti-arrhythmic treatment (beta-blockers or digoxins are acceptable)
- •- Use of CYP3A4 inhibitors or derivatives (see 5.4 Restricted Concomitant Treatment)
- •Pregnant women, lactating women, or likely pregnant women who will not take appropriate contraception
- •a combination of other experimental drugs undergoing clinical trials
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