Freiburg ZNS-NHL Study: Therapy for Patients With Primary Non-Hodgkin Lymphoma of the CNS - Sequential High Dosage Chemotherapy With Autologous Peripheral Blood Stem Cell Plantation
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 78
- 试验地点
- 1
- 主要终点
- Complete response rate
研究概览
简要总结
The purpose of this study is to determine whether combined chemotherapy [rituximab plus high dosage methotrexate (max. 2 cycles) followed by arabinoside/thiotepa (max. 2 cycles) followed by high dosage carmustin/thiotepa] followed by peripheral blood stem cell transplantation is effective in the treatment of cerebral Non Hodgkin lymphoma [PCNSL].
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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
- •group A: first diagnosis of PCNSL, histologically confirmed
- •group B: relapse or progression of PCNSL after MTX containing chemotherapy
- •age 18 - 65 years
- •not legally incompetent, physically or mentally incapable of giving consent
- •written signed and dated informed consent of the legal representative and - if possible - of the patient
排除标准
- •manifestations of further lymphoma outside the CNS
- •sero-positive for HIV
- •severe pulmonary, cardiac, hepatic, renal impairment
- •neutrophil count < 2.000/µl, platelet count < 100.000/µl
- •pulmonary disease with IVC < 55%, DLCO < 40%
- •cardiac ejection fraction < 50%, uncontrolled malign arrhythmia
- •creatinine > 1,5 mg% or creatinine-clearance < 50ml/min
- •bilirubin > 2mg/dl
- •ascites or pleural effusion (> 500ml)
- •pregnancy o r lactation
- •women with childbearing potential without sufficient contraception
- •participation in another clinical trial within the last 30 days prior to the begin or parallel to this study
- •known or current drug or alcohol abuse
- •known hypersensitivity against methotrexate, cytarabine, thiotepa, BCNU rituximab, leukovorin, dexamethasone, neupogen and neulasta.
研究组 & 干预措施
A
first diagnosis of PCNSL: combined chemotherapy with methotrexate
干预措施: methotrexate (Drug)
A
first diagnosis of PCNSL: combined chemotherapy with methotrexate
干预措施: Rituximab (Drug)
A
first diagnosis of PCNSL: combined chemotherapy with methotrexate
干预措施: Cytarabine (Drug)
A
first diagnosis of PCNSL: combined chemotherapy with methotrexate
干预措施: Thiotepa (Drug)
A
first diagnosis of PCNSL: combined chemotherapy with methotrexate
干预措施: Carmustin (Drug)
B
Patients with relapse or progressive disease of PCNSL after methotrexate containing chemotherapy
干预措施: Rituximab (Drug)
B
Patients with relapse or progressive disease of PCNSL after methotrexate containing chemotherapy
干预措施: Cytarabine (Drug)
B
Patients with relapse or progressive disease of PCNSL after methotrexate containing chemotherapy
干预措施: Thiotepa (Drug)
B
Patients with relapse or progressive disease of PCNSL after methotrexate containing chemotherapy
干预措施: Carmustin (Drug)
结局指标
主要结局
Complete response rate
时间窗: 30 days after blood stem cell transplantation
次要结局
- Duration of response(within 5 years)
- Overall survival time(within 5 years)
- Neuropsychological state according to Mini-Mental State(within 5 years)
- Neuropsychological assessment (digit span, Hopkins verbal Learning Test-Revised, Trials 1-3, Brief Test of Attention, Trial Making Test, Grooved Pegboard, 6. HVLT-R , EORTC L C30 , EORTC BN20)(within 5 years)
- (Serious) adverse events ([S]AEs)(within 30 days after treatment)