ITMCTR2200005910尚未招募1 期
Clinical Study on Preventing CIN for Non-Hodgkin's Lymphoma with Icaritin Soft Capsules
适应症
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional study
入排标准
- 年龄范围
- 18 至 —（—）
- 性别
- All
入选标准
- •Patients must meet all of the following criteria to be enrolled in the study:
- •1)Male or female patients aged over 18 years;
- •2)The newly diagnosed patients with non-Hodgkin's lymphoma, and the lymphoid tissue tumor type is B-cell lymphoma patients, CD20 antigen positive;
- •3)Patients who previously received R CHOP in Cycle 1-2 of chemotherapy and only experienced grade I/II neutropenia, and are goning to receive R CHOP therapy in subsequent cycles;
- •4)Bone marrow, liver and kidney function meet the following requirements (white blood cells = 3.5 × 10*9/Lneutrophils = 1.5 × 10*9/L Platelets = 80 × 10*9/L, hemoglobin = 75 g/L; serum bilirubin = 1.5 × ULN; alanine aminotransferase and aspartate aminotransferase = 2.5 × ULN or = 5 × ULN with liver metastasis; alkaline phosphatase = 2.5 × ULN or = 5 × ULN with liver metastasis; serum creatinine = 1.5 × ULN or creatinine clearance > 50 mL/min), no contraindications to chemotherapy;
- •5)Prothrombin time (PT) and international normalized ratio (INR) = 1.5 × ULN, activated partial thromboplastin time (APTT) = 1.5 × ULN;
- •6)Expected survival = 6 months;
- •7)ECOG score = 2;
- •8)No psychiatric history, no severe psychological disorders and cognitive dysfunction;
- •9)Women of childbearing potential must have a negative pregnancy test within 7 days before the start of treatment; men of childbearing potential: take effective contraceptive measures during treatment and within 3 months after the end of treatment;
- •10)Patients who did not participate in other clinical trials before screening; patients who failed in screening in other trials but met the requirements of this trial can be excluded;
- •11)Voluntary participation in this study, signed informed consent, and good compliance.
排除标准
- •Patients meeting any of the following criteria were not to be enrolled in the study
- •1)Use of drugs that have an effect on white blood cells (such as immunosuppressive agents, non-steroidal anti-inflammatory drugs, granulocyte colony-stimulating factor and other western medicine or traditional Chinese medicine with a clear increase or decrease in white blood cells), tonic drugs (such as ginseng, Cordyceps, etc.);
- •2)The adverse reactions caused by previous anti-tumor treatment have not recovered to CTCAE 5.0 grade = 1 (except for toxicities without safety risk as judged by investigators, such as alopecia, grade 2 peripheral neurotoxicity, hypothyroidism stabilized by hormone replacement therapy, etc.);
- •3)History of severe heart, liver, lung, brain, kidney and other vital organ system diseases, autoimmune diseases, myelodysplastic syndrome or severe blood system diseases accompanied by sickle cell disease;
- •4)Patients with relapsed or refractory non-Hodgkin's lymphoma;
- •5)Patients with lymphoma bone marrow infiltration confirmed by bone marrow cytology and flow cytometry;
- •6)Patients with hypersplenism;
- •7)Patients who have received hematopoietic stem cell transplantation or organ transplantation;
- •8)Human immunodeficiency virus (HIV) seropositive;
- •9)Active hepatitis B (HBsAg positive and HBV-DNA > 500 IU/ml), HCV-Ab positive and HCV-RNA > lower limit of detection in the study site;
- •10)Patients planned to receive radiotherapy at the same time;
- •11)Patients who intend to use other anti-tumor therapy during the study, or have excessive surgery or major trauma within 28 days before enrollment, or are expected to require major surgery during the study;
- •12)Patients with other malignant tumors within 5 years before enrollment, except for cured cervical carcinoma in situ and cured cutaneous basal cell carcinoma;
- •13)Active infection before enrollment or systemic anti-infective treatment within 72 hours before chemotherapy;
- •14)Patients with mechanical eating disorders such as gastrointestinal obstruction and masticatory dysphagia; patients with frequent vomiting, or patients with hematemesis and hematochezia requiring fasting;
- •15)Pregnant and lactating women;
- •16)Potential or known hypersensitivity to any component of the study medication;
- •17)Patients with poor compliance or mental disorders who cannot take medicine regularly, which affects the efficacy evaluation or safety evaluation;
- •18)Other conditions that, in the opinion of the investigator, make participation in the study unsuitable.
研究者
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