NCT00521560已完成2 期
Phase I/II Study Concomitant High-Dose Radio-Immuno- and Chemotherapy With Simultaneous Application of Zevalin and BEAM Followed by Autologous Peripheral Stem Cell Transplantation in Relapsed and Refractory CD 20+ Non-Hodgkin's Lymphoma
Institut fuer anwendungsorientierte Forschung und klinische Studien GmbH1 个研究点 分布在 1 个国家目标入组 28 人开始时间: 2006年3月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- The primary outcome variable is the highest achievable dose level of 90Y-Zevalin administered immediately before BEAM high-dose therapy and followed by autologous stem cell transplantation.
研究概览
简要总结
Phase II Study Concomitant High-Dose Radio-Immuno- and Chemotherapy with simultaneous application of Zevalin and BEAM followed by autologous peripheral stem cell transplantation in relapsed and refractory CD 20+ Non-Hodgkin's lymphoma
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
- •Age: 18 - 65 years
- •Risk group: 1) Progression on primary therapy 2) Initial or subsequent relapse
- •Histology: Diagnosis of relapsed aggressive non-Hodgkin lymphoma, whenever possible confirmed by an excision biopsy of a lymph node or by a sufficiently large biopsy of an extranodal site if no lymph node lesion is present. The expression of the CD20 antigen must be demonstrated in the primary lesion or in the relapse. Specifically, the following entities can be treated in this study:
- •Grade III B follicular lymphoma Diffuse B-cell lymphoma centroblastic immunoblastic plasmoblastic anaplastic-large-cell T-cell rich B-cell lymphoma Primary effusion lymphoma Intravascular B-cell lymphoma Primary mediastinal B-cell lymphoma Mantle cell lymphoma, blastoid Variants of Burkitt's lymphoma Aggressive marginal zone lymphoma (monocytoid)
- •General condition: General condition ECOG 0-3 (Karnofsky: 40 - 100 %); for definition see Annex 14.10
- •Presence of declaration of participation of the center and the patient's written consent form
排除标准
- •Prior mediastinal or extensive abdominal irradiation
- •Prior high-dose therapy and autologous stem cell transplantation
- •Impairment of renal function (creatinine > 2.5 mg/dL, creatinine clearance < 20 mL/min)
- •Impairment of hepatic function (bilirubin > 2.0 mg/dL, cholinesterase [CHE] < 2000 U/L)
- •Impairment of pulmonary function (transfer lung factor for CO [TLCO] < 50 %, forced expiratory volume in 1 sec [FEV1] < 60 %, vital capacity [VC] < 60 %)
- •Relevant deterioration of the above organ functions on salvage therapy
- •Failure of stem cell mobilization
- •Active viral hepatitis
- •HIV infection
- •Other active or not conclusively curatively treated malignoma
- •Severe concomitant psychiatric illness or suspected lack of patient compliance
- •Pregnancy or unreliable contraception
- •Highly dynamic progress of lymphoma (lactate dehydrogenase [LDH] > 1.5 x upper limit of normal [ULN]) after salvage therapy immediately prior to radioimmunotherapy
研究组 & 干预措施
1
Experimental
干预措施: Zevalin (Drug)
结局指标
主要结局
The primary outcome variable is the highest achievable dose level of 90Y-Zevalin administered immediately before BEAM high-dose therapy and followed by autologous stem cell transplantation.
时间窗: 3 Year
次要结局
- Treatment related mortality (TRM), freedom from progression (FFP), Survival (OS), progression free survival (PFS) grade III -IV toxicity (CTC) on lung, liver and kidney(3 Years)
研究者
研究点 (1)
Loading locations...
相似试验
进行中（未招募）
不适用
Immunotherapy Combined With Chemoradiotherapy for First-line Treatment of Esophageal Squamous Cell Carcinoma（ChinECR）ESCCNCT06478355Hebei Medical University Fourth Hospital800
已完成
2 期
Pembrolizumab and Chemoradiation Treatment for Advanced Cervical CancerCervical CancerNCT02635360Linda R Duska94
已完成
不适用
Chemoradiotherapy for Limited Advanced Unresectable Thymic Epithelial TumorsThymoma and Thymic CarcinomaNCT02636556Fudan University56
已完成
2 期
Phase II Two-step Radioimmunotherapy Clinical Study in Medullary Thyroid CarcinomaThyroid NeoplasmsNCT00467506Nantes University Hospital
Unknown
2 期
CCRT With Itraconazole in Locally Advanced Squamous Esophageal CancerEsophageal NeoplasmEsophageal DiseasesEsophageal Squamous Cell CarcinomaNCT04481100Hangzhou Cancer Hospital38