NCT02836639Unknown2 期
Phase II Study for Safety and Efficacy of BEB (Bendamustine, Etoposide, Busulfan) Conditioning Regimen for ASCT in Non-Hodgkin's Lymphoma
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Progression-free survival
研究概览
简要总结
Phase II study for safety and efficacy of BEB (Bendamustine, Etoposide, Busulfan) conditioning regimen for ASCT in non-Hodgkin's lymphoma
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
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with histologically diagnosed non-Hodgkin's lymphoma
- •16 ≤ Age ≤ 65 years
- •Adequate cardiac function with cardiac ejection fraction greater than 50% by echocardiogram or multiple gated acquisition scan(MUGA)
- •Adequate kidney function with serum creatinine< 2.0 mg/dL
- •Adequate liver function with /serum bilirubin lower than 2 times the normal upper limit, Aspartate aminotransferase(AST)/ Alanine aminotransaminase(ALT) lower than 3 times the normal upper limit. In case of DLBCL liver invasion; serum bilirubin lower than 5 times the normal upper limit, AST/ALT lower than 5 times the normal upper limit.
- •Adequate bone marrow function with absolute neutrophil count ≥ 1,500/µL; platelets ≥ 75,000/µL; hemoglobin ≥ 9.0 g/dL
- •Patients who voluntarily gave informed consent before performing any test that is not part of routine care of patients
- •Candidate for ASCT
排除标准
- •Positive serology for HIV, hepatitis C virus(HCV) If the hepatitis B virus(HBV) patient was administrated prophylactic antiviral agents. It would be eligible following the judgment of the investigator
- •Pregnant or breast-feeding. Females of childbearing potential who do not agree to undergo pregnancy tests or repeated use effective birth control while included in the clinical trial.
- •Patients with serious or uncontrolled medical condition; 1) Abnormalities in cardiac function or clinically significant heart disease such as congestive heart failure, arrhythmia, unstable angina with treatment within 6 months or acute myocardial infarction; 2) Previous history of serious neurological or psychiatric disease; 3) Acute, severe active infection requiring immediate treatment(Virus, Bacteria, Fungal infection); 4) chronic obstructive pulmonary disease requiring oral steroid therapy or Forced expiratory volume 1 sec(FEV1)<0.8 L less than the test of pulmonary function at rest; 5) If there are other diseases that are deemed inappropriate as a target of the present clinical trial following the Investigator's judgment; 6) Congenital or acquired bleeding disorders
- •Patients receiving any other investigational systemic therapy (Hormone, Immune, chemotherapy)
- •Allergic to the investigational drug
- •Patients who have difficulty understanding the informed consent form or patients who did not give consent
- •Serum bilirubin upper than 2 times the normal upper limit
- •Major surgery procedure within 30 days prior to start of investigational treatment
- •Patients vaccinated against yellow fever
研究组 & 干预措施
Busulfan, Etoposide, Bendamustine
Experimental
All patients will receive the conditioning regimen followed by autologous stem cell transplantation.
干预措施: Busulfan (Drug)
Busulfan, Etoposide, Bendamustine
Experimental
All patients will receive the conditioning regimen followed by autologous stem cell transplantation.
干预措施: Etoposide (Drug)
Busulfan, Etoposide, Bendamustine
Experimental
All patients will receive the conditioning regimen followed by autologous stem cell transplantation.
干预措施: Bendamustine (Drug)
结局指标
主要结局
Progression-free survival
时间窗: 3 years after ASCT
次要结局
- Overall survival(1 year and 3 year after ASCT)
- Complete response rate(1 year and 3 year after ASCT)
- Incidence of adverse events(1 year and 3 year after ASCT)
研究者
Ho-Jin Shin
Professor department of hematooncology
Pusan National University Hospital
研究点 (1)
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