Multicenter Study to Optimise Therapy of B-ALL, Burkitt's NHL and High-Grade Non-Hodgkin's Lymphoma in Adults (Amend 7)
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 650
- 试验地点
- 1
- 主要终点
- Remission rate
研究概览
简要总结
The study evaluates the efficacy and tolerability of alternating short cycles of high-dose and conventional chemotherapy in combination with rituximab in CD20 positive patients, followed by local radiation therapy in the case of initial mediastinal or central nervous system (CNS) involvement or a residual tumor after chemotherapy. A dose-reduced regimen is offered for patients estimated to be over 55 years, biologically.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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 65 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Burkitt's leukemia or Burkitt's lymphoma or primary mediastinal large B-cell lymphoma or B-precursor lymphoblastic lymphoma or large cell anaplastic lymphoma
- •Age > 15 years
- •Written informed consent
排除标准
- •Serious secondary diseases, including psychiatric conditions, under which the required therapy compliance is not to be expected
- •HIV infection
- •Secondary lymphoma following prior chemotherapy/radiotherapy or active second malignancy
- •Known severe allergy to foreign proteins
- •Pre-treatment other than 1 cycle CHOP or similar; < 1 week of another chemotherapy.
- •Pregnancy or nursing
- •Participation in other studies that interfere with study therapy
研究组 & 干预措施
Experimental
This is a single arm trial with complex chemotherapy (6 cycles) stratified by age, subtype (Burkitt-leukemia vs Burkitt-lymphoma) and initial involvement
干预措施: Adriamycin (Drug)
Experimental
This is a single arm trial with complex chemotherapy (6 cycles) stratified by age, subtype (Burkitt-leukemia vs Burkitt-lymphoma) and initial involvement
干预措施: Cyclophosphamide (Drug)
Experimental
This is a single arm trial with complex chemotherapy (6 cycles) stratified by age, subtype (Burkitt-leukemia vs Burkitt-lymphoma) and initial involvement
干预措施: Cytarabine (Drug)
Experimental
This is a single arm trial with complex chemotherapy (6 cycles) stratified by age, subtype (Burkitt-leukemia vs Burkitt-lymphoma) and initial involvement
干预措施: Dexamethasone/Prednisolone (Drug)
Experimental
This is a single arm trial with complex chemotherapy (6 cycles) stratified by age, subtype (Burkitt-leukemia vs Burkitt-lymphoma) and initial involvement
干预措施: VP16 (Drug)
Experimental
This is a single arm trial with complex chemotherapy (6 cycles) stratified by age, subtype (Burkitt-leukemia vs Burkitt-lymphoma) and initial involvement
干预措施: Ifosfamide (Drug)
Experimental
This is a single arm trial with complex chemotherapy (6 cycles) stratified by age, subtype (Burkitt-leukemia vs Burkitt-lymphoma) and initial involvement
干预措施: Methotrexate (Drug)
Experimental
This is a single arm trial with complex chemotherapy (6 cycles) stratified by age, subtype (Burkitt-leukemia vs Burkitt-lymphoma) and initial involvement
干预措施: G-CSF (Drug)
Experimental
This is a single arm trial with complex chemotherapy (6 cycles) stratified by age, subtype (Burkitt-leukemia vs Burkitt-lymphoma) and initial involvement
干预措施: Rituximab (Drug)
Experimental
This is a single arm trial with complex chemotherapy (6 cycles) stratified by age, subtype (Burkitt-leukemia vs Burkitt-lymphoma) and initial involvement
干预措施: Vincristine/Vindesine (Drug)
Experimental
This is a single arm trial with complex chemotherapy (6 cycles) stratified by age, subtype (Burkitt-leukemia vs Burkitt-lymphoma) and initial involvement
干预措施: Irradiation (in specific conditions) (Procedure)
结局指标
主要结局
Remission rate
Remission duration
Disease free survival
Overall survival
次要结局
- Dose and time compliance
- Toxicity according to National Cancer Institute (NCI)-Common Toxicity Criteria (CTC)
- Death under therapy and in complete remission (CR)
- Localisations of relapse
研究者
Nicola Goekbuget
Study Coordinator
Goethe University