A Phase II Study of Rituximab + ABVD for Patients With Hodgkin's Disease
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 85
- 试验地点
- 1
- 主要终点
- 5-year Failure-free Survival Rate for Participants With Hodgkin's Disease Given Rituximab With ABVD
研究概览
简要总结
Primary Objective:
- To determine the feasibility, toxicity, and efficacy of Rituximab with standard dose ABVD combination chemotherapy.
ABVD combination chemotherapy consists of Adriamycin, Bleomycin, Vinblastine and DTIC.
详细描述
Before treatment starts, patients will have a physical exam. Bone marrow samples will be taken. Blood samples (4 to 8 tablespoons) will be taken before and during the study. A chest x-ray, CT scans of the abdomen and pelvis, and a gallium scan will be done if necessary.
Patients in this study will receive rituximab by vein over 3 to 8 hours weekly for 6 weeks in a row. ABVD will be injected over 3 hours every other week for a total of 12 treatments. On the cycles where both rituximab and ABVD are given, rituximab will be given on day 1, and ABVD will be given on day 2. Response to therapy will be determined after 3 months and at the end of therapy (6 months). At the end, patients may receive radiation therapy to areas of large masses. All treatments can be given in an outpatient setting.
Scans and x-rays will be repeated if needed after completion of therapy and every 3 months from then on. If tumors do not shrink after 3 months of therapy, patients will be offered a different treatment.
This is an investigational study. Although ABVD is considered the standard treatment for patients with Hodgkin's disease, the combination of ABVD with rituximab is considered investigational. All drugs involved in this study are commercially available and are approved by the FDA. Up to 85 patients will take part in this study. All will be enrolled at M. D. Anderson. This protocol is partially funded by a research grant from Genentech.
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
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Hodgkin's disease patients who relapse after radiation therapy alone and previously untreated patients with stage II bulky, III and IV who are eligible for ABVD.
- •Must have histologically proven diagnosis of Hodgkin's disease (Nodular sclerosis or mixed cellularity).
- •Must have bidimensionally measurable disease.
- •Must sign a consent form.
- •Must be older than 16 years of age.
- •Must have adequate bone marrow reserve (ANC > 1,000/microL, Platelet > 100,000/microL
- •Left Ventricular Ejection Fraction (LVEF) >/= 50% by multigated acquisition (MUGA) scan or echocardiogram.
- •Serum creatinine < 2 mg/dl, serum bilirubin < 2 mg/dl
排除标准
- •HIV positive.
- •Pregnant women and women of child bearing age who are not practicing adequate contraception.
- •Prior chemotherapy.
- •Severe pulmonary disease including Chronic obstructive pulmonary disease (COPD) and asthma.
研究组 & 干预措施
Rituximab + ABVD Chemotherapy
Rituximab 375 mg/m^2 by vein (IV) over 3 to 8 hours weekly for 6 weeks in a row. ABVD Chemo: Adriamycin 25 mg/m^2 IV, Bleomycin 10 U/m^2 IV, Vinblastine 6 mg/m^2 IV, DTIC 375 mg/m^2 IV. Each but Rituximab over 3 hours every other week for a total of 12 treatments.
干预措施: Rituximab (Drug)
Rituximab + ABVD Chemotherapy
Rituximab 375 mg/m^2 by vein (IV) over 3 to 8 hours weekly for 6 weeks in a row. ABVD Chemo: Adriamycin 25 mg/m^2 IV, Bleomycin 10 U/m^2 IV, Vinblastine 6 mg/m^2 IV, DTIC 375 mg/m^2 IV. Each but Rituximab over 3 hours every other week for a total of 12 treatments.
干预措施: Adriamycin (Drug)
Rituximab + ABVD Chemotherapy
Rituximab 375 mg/m^2 by vein (IV) over 3 to 8 hours weekly for 6 weeks in a row. ABVD Chemo: Adriamycin 25 mg/m^2 IV, Bleomycin 10 U/m^2 IV, Vinblastine 6 mg/m^2 IV, DTIC 375 mg/m^2 IV. Each but Rituximab over 3 hours every other week for a total of 12 treatments.
干预措施: Bleomycin (Drug)
Rituximab + ABVD Chemotherapy
Rituximab 375 mg/m^2 by vein (IV) over 3 to 8 hours weekly for 6 weeks in a row. ABVD Chemo: Adriamycin 25 mg/m^2 IV, Bleomycin 10 U/m^2 IV, Vinblastine 6 mg/m^2 IV, DTIC 375 mg/m^2 IV. Each but Rituximab over 3 hours every other week for a total of 12 treatments.
干预措施: Vinblastine (Drug)
Rituximab + ABVD Chemotherapy
Rituximab 375 mg/m^2 by vein (IV) over 3 to 8 hours weekly for 6 weeks in a row. ABVD Chemo: Adriamycin 25 mg/m^2 IV, Bleomycin 10 U/m^2 IV, Vinblastine 6 mg/m^2 IV, DTIC 375 mg/m^2 IV. Each but Rituximab over 3 hours every other week for a total of 12 treatments.
干预措施: Dacarbazine (DTIC) (Drug)
结局指标
主要结局
5-year Failure-free Survival Rate for Participants With Hodgkin's Disease Given Rituximab With ABVD
时间窗: Baseline to 5 Years or until disease progression
Five year Event Free Survival (EFS) is proportion of surviving participants who remain event free out of total participants at 5 years after receiving Rituximab + ABVD (RABVD). Event-free Survival (EFS) analyzed every 6 months.
次要结局
未报告次要终点