A Prospective Phase II Trial on R-CHOP Followed by High-dose BEAM and Autologous SCT and HLA-identical Allogenic SCT After Dose-reduced Conditioning in Patients Age < 55 Years With Primary Mantle-Cell-Lymphoma
试验速览
- 阶段
- 2 期
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Efficacy: ORR, OS, EFS
研究概览
简要总结
The purpose of this study is to improve the overall survival of Mantle-Cell-Lymphoma (MCL) by a new concept of treatment with primary curative intention consisting of six courses of immunochemotherapy followed by high-dose chemotherapy and autologous stem cell transplantation (SCT) and HLA-identical allogenic SCT after a dose-reduced conditioning regimen of total body irradiation (TBI) with 2 Gy and Fludarabine in younger patients with primary Mantle-Cell-Lymphoma
详细描述
With a median overall survival of approximately 3 years, MCL has the poorest prognosis of all NHL entities. No potentially curative therapy has been established yet as even more intensive therapies including high-dose chemotherapy plus autologous SCT show only moderate improvement of the prognosis of MCL. Allogenic SCT seems to have an immunological mechanism of action in NHL, which is commonly known as Graft-versus-Lymphoma effect. This trial´s purpose is to improve the overall survival in patients younger than 55 years with primary MCL by sequentially combining autologous SCT and allogenic SCT after the application of 6 courses of immunochemotherapy and high-dose chemotherapy.
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 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •First diagnosis of Mantle-Cell-Lymphoma without any previous therapies except for pre-phase treatment consisting of steroids
- •Age 18 to 55 years
- •Confirmed CD20-expression on lymphocytes
- •Effective methods of contraception and negative pregnancy test
- •Sufficient compliance
- •Written patient´s informed consent
排除标准
- •Manifest cardiac insufficiency, not compensated
- •Congestive Cardiomyopathy
- •Chronic pulmonary disease including hypoxemia
- •Severe hypertension, not condensable with drugs
- •Severe diabetes mellitus not condensable with drugs
- •Renal Insufficiency ( serum creatinin > 2,0 mg/dl, other than Lymphoma related)
- •Liver impairment ( Transaminases value more than 3 x upper normal value or Bilirubin > 2,0 mg/dl, other than Lymphoma related)
- •HIV-Infection
- •Active Hepatitis B-Infection if continuous virostatic treatment is not possible
- •Active Hepatitis C-Infection
- •Clinical signs of cerebrovascular insufficiency or cerebral damages
- •Pregnancy, lactation or inadequate contraception in women of childbearing age
- •Severe psychiatric disorders
- •Transplantation in the past
结局指标
主要结局
Efficacy: ORR, OS, EFS
时间窗: during treatment and on day 720 after allogenic SCT
次要结局
- Toxicity according to WHO-Grading(During treatment and until follow-up)
- GvL-effect after allogenic SCT(Allogenic SCT until day 720 after transplantation)
- Comparison of OS between patients completing the protocol and patients not receiving allogenic SCT(First diagnosis of MCL until day 720 after transplantation)