NCT00388193已完成2 期
Burkimab:Study Multicenter of Optimization of the Treatment of LLA-B and the Burkitt's Lymphoma in Adult Patients (From 15 Years Old)
PETHEMA Foundation15 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2006年8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
- 20
- 试验地点
- 15
- 主要终点
- Determinate the efficacy of the administration of anti-CD20 (RITUXIMAB) combined with chemotherapy.
研究概览
简要总结
The purpose of this clinical trial is to prove the efficacy of the following new regimen treatment:
- Administration of anti-CD20 (Rituximab) combined with chemotherapy.
- Combined treatment with high doses of methotrexate and high doses of cytarabine with conventional cytostatics (block C)
- Prophylactic administration of G-CSF after all chemotherapy cycles
- local irradiation after 6 cycle if CNS was affected or if there are residual tumour
详细描述
Clinical Trial with a pharmaceutical speciality in new conditions to use.
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
- 15 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients diagnosed with mature LLA-B cell (LLA-L3)
- •Patients diagnosed with Burkitt´s and Burkitt´s Like Lymphoma
- •Patients 15 years old or up
- •Written Informed Consent signed
排除标准
- •Serious complications related with LAL3/LB or Secondary illness:
- •Serious complications, uncontrollable, for example, sepsis, pneumonia with hypoxia, shock, haemorrhage at diagnosis.
- •Renal failure unconditional for the Lymphoma/Leukemia
- •Heart failure or serious liver.
- •Pulmonary obstructive disease or serious restrictive that not allow to treat the patient with intensive chemotherapy.
- •Secondary Lymphoma after chemotherapy or previous radiotherapy or second malignant tumour.
- •Known hypersensitivity to any foreign protein.
- •Previous treatment with cytostatics of the LLA-B or Burkitt´s Lymphoma (exception: administration on short time of glucocorticoids ≤ 7 days, one administration of vincristine or cyclophosphamide, one cycle of CHOP, urgent administration of the another cytostatics).
- •With another malignant tumour in the last 5 year.
- •Women in fertile age must give positive in the pregnancy test or nursing mother.
- •Mental disability or emotional or psychiatric significant disorder were the patient can't understand nor cooperate with treatment.
- •Patients is enrolled in another clinical research study.
研究组 & 干预措施
1
Experimental
干预措施: RITUXIMAB (Drug)
结局指标
主要结局
Determinate the efficacy of the administration of anti-CD20 (RITUXIMAB) combined with chemotherapy.
时间窗: 1 year
次要结局
- Combined treatment with high doses of methotrexate and high doses of cytarabine with conventional cytostatics (block C)(1 year)
- Prophylactic administration of G-CSF after all chemotherapy cycles(1 year)
- local irradiation after 6 cycle if CNS was affected or if there are residual tumour(1 year)
研究者
研究点 (15)
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