A Phase II, Multicenter, Prospective, Non-randomised, Open-label, Clinical Trial to Evaluate Effectiveness and Safety of BeEAC Conditioning Regimen in Malignant Lymphoma Subjects With Indications to Autologous Hematopoietic Stem-cell Transplantation
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Incidence of Treatment-Emergent Adverse Events
研究概览
简要总结
Nowadays there is no randomized trials for comparison the effectiveness and tolerability of different conditioning regimens.
Bendamustine is a unique chemotherapeutic agent that combines alkylating action of nitrogen mustard and the activity of purine antimetabolite. Bendamustine has shown its effectiveness for the treatment of patients with chronic lymphoproliferative diseases such as chronic lymphocytic leukemia and several indolent lymphomas. The literature also presents evidence of the effectiveness bendamustine in patients with Hodgkin's lymphoma who received multiple lines of prior chemotherapy, including high dose chemotherapy and transplantation of peripheral hematopoietic stem cells. There are also data of using bendamustine as a part of conditioning regimen.
In this context, it was planned a study for evaluation the safety and effectiveness of the BeEAC (bendamustine, etoposide, cytarabine, cyclophosphamide) conditioning regimen prior to autologous transplantation of peripheral hematopoietic stem cells for the treatment of relapsed/refractory malignant lymphomas.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Be willing and able to provide written informed consent for the trial
- •Be ≥ 18 years of age on day of signing informed consent
- •Eastern Cooperative Oncology Group (ECOG) <
- •Relapsed/refractory malignant lymphoma patients with indications to autologous hematopoietic stem-cell transplantation
排除标准
- •Participation in another clinical trials
- •Clinically relevant heart disease:
- •Myocardial infarction during previous 6 months
- •Unstable angina during previous 3 months
- •Congestive heart failure (III-IV NYHA)
- •Clinically relevant ventricular arrhythmias
- •corrected QT interval (QTc) > 460 мс on ECG (calculated using Frederics formula)
- •Left ventricular ejection fraction ≤ 45% on Echocardiogram
- •Atrial Hypotension (systolic pressure < 86 mmHg) or bradycardia (< 50 per minute, exclusion - drug-induced bradycardia)
- •Uncontrolled arterial hypertension (systolic pressure > 170 mmHg or diastolic pressure > 105 mmHg)
- •Severe renal dysfunction (serum creatinine > 250 µmol/l)
- •Severe hepatic dysfunction (total bilirubin > 40 µmol/l)
- •Known history of Human Immunodeficiency Virus or active Hepatitis B and C
- •Psychiatric or substance abuse disorders that would interfere with the cooperation with the requirements of the trial
- •Hypersensitivity to investigational drugs
- •Pregnant or breastfeeding females or males and females with childbearing potential must be willing to use an adequate method of birth control (intrauterine device, vasectomy of female subjects' male partner, contraceptive rod implanted into the skin, combination method - (requires use of two of the following) diaphragm with spermicide, cervical cap spermicide, contraceptive sponge, condom, hormonal contraceptive)
研究组 & 干预措施
Relapsed/refractory malignant lymphomas
Malignant Lymphoma Subjects With Indications to Autologous Hematopoietic Stem-cell Transplantation using BeEAC (Bendamustine, Cytarabine, Etoposide, Cyclophosphamide) conditioning regimen
干预措施: Bendamustine (Drug)
结局指标
主要结局
Incidence of Treatment-Emergent Adverse Events
时间窗: From admission till discharge from the hospital (approximately 30 days)
The primary safety analysis will be based on subjects who experienced toxicities as defined by CTCAE criteria. Safety will be assessed by quantifying the toxicities and grades experienced by subjects who have received BeEAC including serious adverse events (SAEs). Adverse experiences will be graded and recorded throughout the study and during the follow-up period according to NCI CTCAE 4.03. Toxicities will be characterized in terms regarding seriousness, causality, toxicity grading and action taking with regard to trial treatment (Incidence of Treatment-Emergent Adverse Events).
次要结局
- Retrospective Comparison of Overall Survival between Carmustine, Etoposide, Cytarabine, Melphalan (BEAM), Cyclophosphamide, Carmustine, Etoposide(CBV) and BeEAC conditioning regimens(2 years)
- Progression-Free Survival(2 years)
- Overall Survival(2 years)
- Retrospective Comparison of Progression-Free Survival between Carmustine, Etoposide, Cytarabine, Melphalan (BEAM), Cyclophosphamide, Carmustine, Etoposide(CBV) and BeEAC conditioning regimens(2 years)