A Randomised Study of High Dose Chemotherapy/Radiotherapy and Autologous Bone Marrow Transplantation in Patients With High Grade Malignant Non-Hodgkin's Lymphoma (Kiel Classification) According to Prognostic Groups
试验速览
- 阶段
- 3 期
- 发起方
- 试验地点
- 2
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage cancer cells. Bone marrow transplantation may allow doctors to give higher doses of chemotherapy drugs and kill more cancer cells.
PURPOSE: Randomized phase III trial to study the effectiveness of chemotherapy and radiation therapy plus bone marrow transplantation in treating patients who have aggressive non-Hodgkin's lymphoma.
详细描述
OBJECTIVES:
- Assess the rate of remission in patients with aggressive non-Hodgkin's lymphoma treated with high-dose chemotherapy and radiotherapy plus autologous bone marrow transplantation.
- Determine the efficacy and toxic effects of this regimen in these patients.
OUTLINE: This is a randomized, placebo-controlled, multicenter study. Patients are stratified according to risk group (good vs intermediate vs poor).
Patients undergo harvest of autologous bone marrow stem cells after priming chemotherapy and before transplantation.
Patients receive induction chemotherapy comprising the CHOP or VAPEC-B regimen. The CHOP regimen consists of vincristine (VCR) IV, cyclophosphamide (CTX) IV, and doxorubicin (DOX) IV on day 1 and oral prednisolone (PRDL) on days 1-5. Treatment repeats every 3 weeks for six courses. The VAPEC-B regimen consists of DOX IV on days 1, 15, 29, 43, 57, and 71; CTX IV on days 1, 29, and 57; VCR IV on days 8, 22, 36, 50, and 64; bleomycin IV on days 8, 36, 64; oral etoposide (VP-16) on days 15-19, 43-47, and 71-75; and oral PRDL daily for 13 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 主要目的
- Treatment
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
- •DISEASE CHARACTERISTICS:
- •Histologically confirmed aggressive non-Hodgkin's lymphoma requiring chemotherapy
- •Stage II, III, or IV
- •Centroblastic
- •Immunoblastic
- •Large cell anaplastic
- •Non-Burkitt lymphoblastic
- •Pleomorphic medium cell
- •Pleomorphic large cell
- •Immunoblastic
- •Large cell anaplastic
- •Lymphoblastic
- •No Burkitt (L3) subtype
- •No large mediastinal mass OR
- •Stage I, II, III, or IV
- •Bulk disease greater than 10 cm
- •Nodal or extranodal site
- •No primary localized gut lymphoma
- •No CNS involvement
- •PATIENT CHARACTERISTICS:
- •Performance status:
- •Not specified
- •Life expectancy:
- •Not specified
- •Hematopoietic:
- •No concurrent bone marrow dysplastic syndromes
- •Bilirubin no greater than 2.5 times upper limit of normal (ULN)
- •Creatinine no greater than 2.5 times ULN
- •No other malignancy except skin cancer or stage I cervical cancer
- •Not pregnant
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy:
- •Not specified
- •Chemotherapy:
- •See Disease Characteristics
- •No prior chemotherapy
- •Endocrine therapy:
- •Not specified
- •Radiotherapy:
- •Not specified
- •Not specified
排除标准
- 未提供