Study Characterizing the Impact of Different Therapeutic Strategies on Event Occurrence at 2 Years, 5 Years, 10 Years, and 15 Years, According to Prognostic Groups in Patients With Hodgkin Lymphoma
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- 入组人数
- 442
- 试验地点
- 1
- 主要终点
- Event-free survival
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving drugs in different combinations may kill more cancer cells. It is not yet know which treatment regimen is more effective in treating Hodgkin lymphoma.
PURPOSE: This phase III trial is studying three different therapy regimens to compare how well they work in treating patients with previously untreated Hodgkin lymphoma.
详细描述
OBJECTIVES:
Primary
- Evaluate event-free survival.
Secondary
- Evaluate overall survival.
- Evaluate the prognostic value of FDG-PET scanning.
- Evaluate progression-free survival.
- Evaluate tolerability.
- Evaluate rate of relapse.
研究设计
- 研究类型
- Interventional
- 分配方式
- 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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Group 1 (favorable prognosis)
Patients receive ABVD and VABEM chemotherapy.
干预措施: bleomycin sulfate (Biological)
Group 1 (favorable prognosis)
Patients receive ABVD and VABEM chemotherapy.
干预措施: ABVD regimen (Drug)
Group 1 (favorable prognosis)
Patients receive ABVD and VABEM chemotherapy.
干预措施: carmustine (Drug)
Group 1 (favorable prognosis)
Patients receive ABVD and VABEM chemotherapy.
干预措施: dacarbazine (Drug)
Group 1 (favorable prognosis)
Patients receive ABVD and VABEM chemotherapy.
干预措施: doxorubicin hydrochloride (Drug)
Group 1 (favorable prognosis)
Patients receive ABVD and VABEM chemotherapy.
干预措施: etoposide (Drug)
Group 1 (favorable prognosis)
Patients receive ABVD and VABEM chemotherapy.
干预措施: methylprednisolone (Drug)
Group 1 (favorable prognosis)
Patients receive ABVD and VABEM chemotherapy.
干预措施: vincristine sulfate (Drug)
Group 1 (favorable prognosis)
Patients receive ABVD and VABEM chemotherapy.
干预措施: vindesine (Drug)
Group 2 (intermediate prognosis)
Patients receive ABVD and VABEM chemotherapy.
干预措施: bleomycin sulfate (Biological)
Group 2 (intermediate prognosis)
Patients receive ABVD and VABEM chemotherapy.
干预措施: ABVD regimen (Drug)
Group 3 (poor prognosis)
Patients receive VABEM, CEO, BEAM, and MINE chemotherapy. Patients also undergo allogeneic or autologous stem cell transplantation.
干预措施: gemcitabine hydrochloride (Drug)
Group 2 (intermediate prognosis)
Patients receive ABVD and VABEM chemotherapy.
干预措施: carmustine (Drug)
Group 2 (intermediate prognosis)
Patients receive ABVD and VABEM chemotherapy.
干预措施: dacarbazine (Drug)
Group 2 (intermediate prognosis)
Patients receive ABVD and VABEM chemotherapy.
干预措施: doxorubicin hydrochloride (Drug)
Group 2 (intermediate prognosis)
Patients receive ABVD and VABEM chemotherapy.
干预措施: etoposide (Drug)
Group 2 (intermediate prognosis)
Patients receive ABVD and VABEM chemotherapy.
干预措施: methylprednisolone (Drug)
Group 2 (intermediate prognosis)
Patients receive ABVD and VABEM chemotherapy.
干预措施: vincristine sulfate (Drug)
Group 2 (intermediate prognosis)
Patients receive ABVD and VABEM chemotherapy.
干预措施: vindesine (Drug)
Group 3 (poor prognosis)
Patients receive VABEM, CEO, BEAM, and MINE chemotherapy. Patients also undergo allogeneic or autologous stem cell transplantation.
干预措施: carmustine (Drug)
Group 3 (poor prognosis)
Patients receive VABEM, CEO, BEAM, and MINE chemotherapy. Patients also undergo allogeneic or autologous stem cell transplantation.
干预措施: cisplatin (Drug)
Group 3 (poor prognosis)
Patients receive VABEM, CEO, BEAM, and MINE chemotherapy. Patients also undergo allogeneic or autologous stem cell transplantation.
干预措施: cytarabine (Drug)
Group 3 (poor prognosis)
Patients receive VABEM, CEO, BEAM, and MINE chemotherapy. Patients also undergo allogeneic or autologous stem cell transplantation.
干预措施: dexamethasone (Drug)
Group 3 (poor prognosis)
Patients receive VABEM, CEO, BEAM, and MINE chemotherapy. Patients also undergo allogeneic or autologous stem cell transplantation.
干预措施: doxorubicin hydrochloride (Drug)
Group 3 (poor prognosis)
Patients receive VABEM, CEO, BEAM, and MINE chemotherapy. Patients also undergo allogeneic or autologous stem cell transplantation.
干预措施: etoposide (Drug)
Group 3 (poor prognosis)
Patients receive VABEM, CEO, BEAM, and MINE chemotherapy. Patients also undergo allogeneic or autologous stem cell transplantation.
干预措施: ifosfamide (Drug)
Group 3 (poor prognosis)
Patients receive VABEM, CEO, BEAM, and MINE chemotherapy. Patients also undergo allogeneic or autologous stem cell transplantation.
干预措施: melphalan (Drug)
Group 3 (poor prognosis)
Patients receive VABEM, CEO, BEAM, and MINE chemotherapy. Patients also undergo allogeneic or autologous stem cell transplantation.
干预措施: methylprednisolone (Drug)
Group 3 (poor prognosis)
Patients receive VABEM, CEO, BEAM, and MINE chemotherapy. Patients also undergo allogeneic or autologous stem cell transplantation.
干预措施: mitoguazone (Drug)
Group 3 (poor prognosis)
Patients receive VABEM, CEO, BEAM, and MINE chemotherapy. Patients also undergo allogeneic or autologous stem cell transplantation.
干预措施: vindesine (Drug)
Group 3 (poor prognosis)
Patients receive VABEM, CEO, BEAM, and MINE chemotherapy. Patients also undergo allogeneic or autologous stem cell transplantation.
干预措施: vinorelbine tartrate (Drug)
Group 3 (poor prognosis)
Patients receive VABEM, CEO, BEAM, and MINE chemotherapy. Patients also undergo allogeneic or autologous stem cell transplantation.
干预措施: allogeneic hematopoietic stem cell transplantation (Procedure)
Group 3 (poor prognosis)
Patients receive VABEM, CEO, BEAM, and MINE chemotherapy. Patients also undergo allogeneic or autologous stem cell transplantation.
干预措施: autologous hematopoietic stem cell transplantation (Procedure)
结局指标
主要结局
Event-free survival
时间窗: treatments evaluation
event free survival
次要结局
未报告次要终点