NCT01718691已完成2 期
Phase II Clinical Study of SyB L-0501 in Combination With Rituximab in Patients With Untreated, Low-grade B-cell Non-Hodgkin's Lymphoma and Mantle Cell Lymphoma (Multicenter, Open-label).
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Complete Response Rate (CR + CRu) Based on International Workshop to Standardize Response Criteria for Non-Hodgkin's Lymphomas (1999)(IWRC)
研究概览
简要总结
The purpose of this study is to assess the efficacy and safety of SyB L-0501 (two-day consecutive 90 mg/m2/day IV drip infusions) in combination with rituximab (375 mg/m2 IV drip infusion) on untreated, low-grade B cell non-Hodgkin's lymphoma and mantle cell lymphoma where hematopoietic stem cell transplantation is not indicated.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 79 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who are histopathologically confirmed to have the following cluster of differentiation 20 (CD20) positive low-grade B cell non-Hodgkin's lymphoma or mantle cell lymphoma by lymph node biopsy or evaluable tissue biopsy within 6 months before the registration WHO Classification of Tumors (fourth edition):
- •Small lymphocytic lymphoma
- •Splenic marginal zone B-cell lymphoma
- •Lymphoplasmacytic lymphoma
- •Extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue (MALT lymphoma)
- •Nodal marginal zone B-cell lymphoma
- •Follicular lymphoma (Grade 1, 2, 3a)
- •Mantle cell lymphoma
- •Patients with a measurable lesion ( > 1.5 cm in major axis on CT)
- •Patients without a medical history
- •Patients with at least 1 of the following clinical symptoms or signs (excluding mantle cell lymphoma):
- •Bulky disease measuring > 7 cm in major axis on CT (excluding spleen)
- •B symptoms
- •Fever exceeding 38.0ºC of unknown cause
- •Night sweats
- •Weight decrease exceeding 10% within 6 months before patient registration
- •Elevated serum LDH or beta 2 microglobulin
- •Three or more regional lymph nodes of > 3 cm in major axis on CT
- •Symptomatic splenomegaly
- •Intracranial pressure
- •Pleural effusion/ascites retention
- •Patients expected to live for at least 3 months
- •Patients aged between 20 and 79 years (at the time of registration)
- •Patients whose Eastern Cooperative Oncology Group (ECOG) performance status (P.S.) is 0～2
- •Patients with adequately maintained major organ function (bone marrow, heart, lungs, liver, kidneys)
- •Neutrophil count: not less than 1,500 /mm3
- •Platelet count: not less than 75,000 /mm3
- •Aspartate aminotransferase (AST)[Glutamic oxaloacetic transaminase (GOT)]: not more than 3 times the standard upper limit for the site
- •Alanine aminotransferase (ALT)[Glutamic pyruvic transaminase (GPT)]: not more than 3 times the standard upper limit for the site
- •Total bilirubin: not more than 1.5 times the standard upper limit for the site
- •Serum creatinine: not more than 1.5 times the standard upper limit for the site
- •Arterial partial pressure of oxygen (PaO2): not less than 65 mmHg
- •Electrocardiogram shows no abnormal findings that require treatment
- •Echocardiogram of left ventricular ejection fraction (LVEF): not less than 55%
- •Patients whose informed consent has been obtained in person
排除标准
- •Patients who fall under any one of the following criteria are to be excluded
- •Patients whose transformation has been confirmed histopathologically
- •Mantle cell lymphoma patients aged 65 years or younger
- •Patients who were administered or received transfusion of cytokine formulations such as G-CSF (granulocyte colony stimulating factor) and erythropoietin within 14 days before pre-registration test
- •Patients with severe active infectious disorders (receiving antibiotics, antifungals, or antivirus IV injection)
- •Patients with serious complications (such as hepatic or renal failure)
- •Patients with severe complications of cardiac disease (examples: myocardial infarction, ischemic heart disease) or its previous history within 2 years before patient registration, and patients with arrhythmia requiring a treatment
- •Patients with serious gastrointestinal conditions (persistent or severe nausea/vomiting or diarrhea)
- •Patients who are positive for hepatitis B surface (HBs) antigen, hepatitis C virus (HCV) antibody or HIV antibody [if HBs or hepatitis B core (HBc) positive, patients whose hepatitis B virus (HBV)-DNA test results indicate positive]
- •Patients with serious bleeding tendencies [such as disseminated intravascular coagulation (DIC)]
- •Patients having or suspected of having symptoms indicative of the central nervous system (CNS) involvement
- •Patients with interstitial pneumonitis, pulmonary fibrosis, pulmonary emphysema complications requiring treatment or its medical history.
- •Patients with active multiple primary cancer
- •Patients who received chemotherapy, radiotherapy, antibody therapy and antitumor steroid therapy in the past
- •Patients with complications or medical history of autoimmune haemolytic anaemia
- •Patients who were administered investigative or unapproved drugs within 3 months before patient registration
- •Patients with addiction to drugs or narcotics, or alcoholism
- •Patients who have previously received hematopoietic stem cell transplantation
- •Patients who are or may be pregnant, lactating patients
- •Patients, whether male or female, who do not agree to use contraception
- •Patients otherwise judged by the investigator or the sub-investigator to be unsuitable for inclusion in the study
研究组 & 干预措施
SyB L-0501＋rituximab
Experimental
干预措施: SyB L-0501 (Drug)
SyB L-0501＋rituximab
Experimental
干预措施: rituximab (Drug)
结局指标
主要结局
Complete Response Rate (CR + CRu) Based on International Workshop to Standardize Response Criteria for Non-Hodgkin's Lymphomas (1999)(IWRC)
时间窗: Up to 30 weeks
The criteria for CR and CRu based on IWRC are shown below. CR: Fulfills all of the following * Disappearance of all detectable disease * LN\* \> 1.5 cm must decrease to ≤ 1.5 cm CRu: Fulfills all of the following * LN \>1.5 cm; SPD\*\* decrease \>75% * indeterminate bone marrow * LN: lymph nodes or nodal masses \*\* SPD: sum of the products of the greatest diameters
次要结局
- Overall Response Rate (PR or Better) Based on "WHO Handbook for Reporting Results of Cancer Treatment (1979)"(Up to 30 weeks)
- Overall Response Rate (Antitumor Effect: PR or Better) Based on International Workshop to Standardize Response Criteria for Non-Hodgkin's Lymphomas (1999)(IWRC)(Up to 30 weeks)
- Complete Response Rate (CR) Based on Revised Response Criteria for Malignant Lymphoma (2007)(Revised RC)(Up to 30 weeks)
- Overall Response Rate (PR or Better) Based on Revised Response Criteria for Malignant Lymphoma (2007)(Revised RC)(Up to 30 weeks)
- Complete Response Rate Based on WHO Handbook for Reporting Results of Cancer Treatment (1979)(Up to 30 weeks)
- Progression-Free Survival (PFS)(Up to 30 weeks)
- Duration of Response (DOR)(Up to 30 weeks)
- Overall Survival (OS)(Up to 30 weeks)
- Number of Subjects With Adverse Event, Related Adverse Event, Serious Adverse Event, and Discontinuation Due to Adverse Event(up to 30 weeks)
- Laboratory Test Abnormalities (Biochemical Tests)(up to 30 weeks)
- Laboratory Test Abnormalities (Hematology Tests)(up to 30 weeks)
研究者
研究点 (1)
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