临床试验/NCT00186251

NCT00186251已完成不适用

Use of High Dose Chemotherapy Followed by Peripheral Blood Stem Cell Rescue for Relapsed or Resistant Hodgkin's Disease

Stanford University2 个研究点分布在 1 个国家目标入组 200 人开始时间: 1998年3月最近更新: 2012年11月12日

适应症

试验速览

阶段: 不适用
状态: 已完成
发起方: Stanford University
入组人数: 200
试验地点: 2
主要终点: Overall survival

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

To evaluate the role of high dose chemotherapy with autologous hematopoietic cell transplantation in the treatment of Hodgkin's Disease.

详细描述

Use of High Dose Chemotherapy Followed by Peripheral Blood Stem Cell Rescue for Relapsed or Resistant Hodgkin's Disease

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: 4 Weeks 至 70 Years（Child, Adult, Older Adult）
性别: All
接受健康志愿者: 否

入选标准

•adequate organ function
•recurrent HD

排除标准

•CNS disease
•no prior malignancy

结局指标

主要结局

Overall survival

FFS

Response rates

次要结局

Toxicity of high dose chemotherapy

研究者

发起方

Stanford University

申办方类型

Other

研究点 (2)

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进行中（未招募）

High-dose chemotherapy and autologous stem cell transplant or consolidating conventional chemotherapy in primary CNS lymphoma -randomized phase III trialPrimary CNS lymphoma (PCNSL) accounts for 1 to 2% of all Non-Hodgkin's lymphomas (NHL) and for 2 to 7% of all primary CNS tumors.It's incidence has increased over the past 30 years, particularly in immunocompetent individuals. Over 90% of PCNSL are lymphomas of Bcell origin, accounting to the subtype diffuse large B-cell lymphoma.(DLBCL). Prognosis without treatment resembles that of systemic highgrade NHL, and the median survival of untreated patients with PCNSL is approximately 3 months.MedDRA version: 21.0Level: PTClassification code 10007953Term: Central nervous system lymphomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)

EUCTR2012-000620-17-ITCITY OF STUTTGART, REPRESENTED BY KLINIKUM STUTTGART250

进行中（未招募）

In the presently planned multicentre Phase III trial the two therapies will be compared: Patients will be randomized after intensified induction treatment with 4 cycles rituximab, methotrexate, cytarabine and thiotepa (MATRix) between first-line high-dose chemotherapy against conventional consolidating therapy with 2 cycles of conventional chemotherapy with R-DeVIC (Rituximab, Dexamthason, Etoposide, Ifosfamide, Carboplatin).Primary CNS lymphoma (PCNSL) accounts for 1 to 2% of all Non-Hodgkin's lymphomas (NHL) and for 2 to 7% of all primary CNS tumors. It's incidence has increased over the past 30 years, particularly in immunocompetent individuals. Over 90% of PCNSL are lymphomas of B-cell origin, accounting to the subtype diffuse large B-cell lymphoma. (DLBCL). Prognosis without treatment resembles that of systemic high-grade NHL, and the median survival of untreated patients with PCNSL is approximately 3 months.

EUCTR2012-000620-17-DEandeshauptstadt Stuttgart, represented by the Executive Medical Director Klinikum Stuttgart330