Selection of Young Patients (< 61 Years), With Good Prognosis Diffuse Large B Cell Lymphoma, According to the Immunophenotype (BCL-6 Negative) to be Treated With Chemoimmunotherapy, With R-CHOP. A Pilot Study.
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 30
- 试验地点
- 1
研究概览
简要总结
The purpose of this study is to determine whether a specific subtype of lymphoma responds optimally to treatment with rituximab and chemotherapy.
详细描述
Treatment with rituximab and chemotherapy (R-CHOP)is the accepted treatment for young patients with diffuse large B cell Non-Hodgkin's Lymphoma. However not every patient benefits with this expensive therapy. Recent data suggest that patients with BCL-6 negative lymphoma are more sensitive to Rituximab therapy. It is also known that patients with high-intermediate and high IPI risk does not benefit form standard three weekly CHOP chemotherapy.
In this study we intend to define a subgroup of patients in whom this therapy will be of maximum benefit.
We will prospectively treat a group of patients with the following characteristics:
< 60 years old low and low intermediate IPI risk BCL-6 negative B-cell NHL Treatment regimen: R-CHOP (standard dosis) for 8 cycles
研究设计
- 研究类型
- Observational
- 观察模型
- Defined Population
- 时间视角
- Prospective
入排标准
- 年龄范围
- 15 Years 至 60 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of Large B cell Non-Hodgkin Lymphoma CD20+
- •BCL-6 negative
- •Age < 61 years old
- •ECOG 2 or less
- •IPI low, low intermediate
- •Stage II, III or IV
- •Signed Informed Consent
排除标准
- •Previous treatment
- •Lymphomatous central nervous system involvement
- •Heart disease
- •Kidney failure (serum creatinine > 2 mg/dl)
- •Viral Hepatitis
- •Pregnancy