Phase III Randomized, Multi-center Study to Evaluate the Effect of R-mabHDI in Patients With Lymphocytic Predominant Hodgkin's Lymphoma
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 1,200
- 试验地点
- 1
- 主要终点
- The primary efficacy criterion is the response rates (RR) by Kaplan-Meier at 3,6,12, and 18 months.
研究概览
简要总结
Objective:
The primary objective of the study is to evaluate the effect of R-mabHDI in patients with late stage, widespread stage and recurrent Lymphocytic Predominant Hodgkin's Lymphoma.
The hypothesis is that the combination of R-mabHDI with the standard ABVD therapy in patients with late stage (Stage III and Stage IV) and recurrent stage Lymphocytic Predominant Hodgkin's Lymphoma will have a favorable outcome on the response and progress free survival. The study is also aimed at evaluating the safety of R-mabHDI .
The aim of the study is to test this hypothesis by evaluating the clinical outcome in 1200 patients receiving combination of R-mabHDI once a week for 8 weeks and ABVD therapy every other week for 12 treatments.
详细描述
The primary objective of the study is to evaluate the effect of R-mabHDI in Patients with late stage, widespread stage and recurrent Lymphocytic Predominant Hodgkin's Lymphoma.
The hypothesis is that the combination of R-mabHDI with the standard ABVD therapy in patients with late stage (Stage III and Stage IV) and recurrent stage Lymphocytic Predominant Hodgkin's Lymphoma will have a favorable outcome on the response and progress free survival. The study is also aimed at evaluating the safety of R-mabHDI .
A total of 1200 subjects will be recruited to the study from various centers. Enrollment period will last for up to one and half year and treatment period is for six months. Treatment will be considered a failure if the tumor size and signs of LPHD does not decrease after 3 months.
Subjects having late stage HD, widespread HD or recurrent HD fulfilling the inclusion and exclusion criteria will be recruited in this study. Females who are nursing babies or are pregnant will be excluded from the study.
All subjects will receive the drugs according to the randomization process. The eligible subjects will be randomly assigned to 1 of 2 "treatment" groups after screening. No matter which group the subjects are assigned to, the doses of the drugs will be the standard doses that are currently used to treat lymphoma.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 16 Years 至 65 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Must sign the informed consent form
- •Patients with proven diagnosis of Lymphocytic Predominant Hodgkin's Lymphoma in late stage HD, widespread HD and recurrent HD on histology.
- •Patients of both gender
- •Patients between ages of 16 and 65 years
- •Patients must have bi-dimensionally measurable disease
- •Patients with adequate bone marrow reserve (ANC>1500/mm3 ; Platelets> 50,000/ mm3)
- •LVEF >/= 50% as measured by echocardiogram
- •Serum creatinine < 2mg/dl
- •Serum bilirubin < 2mg/dl; AST or ALT < 2x ULN
- •International Prognostic Score of >2 (Patients must have > 2 of the following risk features: Male >/= 45 years of age, Stage IV, Albumin <4, WBC >/= 15, Lymphocytes < 8% or < 600, Hb < 10.5)
排除标准
- •Classic Hodgkin's disease
- •Known HIV infection
- •Pregnant women and women of child bearing capacity, tests positive on a urine/blood pregnancy test, is lactating/nursing, has had three or more days of amenorrhea at the time of first dose of the treatment, is contemplating pregnancy in next six months or is not using an efficient contraceptive method.
- •Severe pulmonary disease as judged by the Principal Investigator including COPD and asthma
- •Acute infection requiring treatment with intravenous therapy
- •Presence of CNS lymphoma
- •Concomitant malignancies or previous malignancies within the last 5 years
- •Active Hepatitis B or C infection
- •Uncontrolled active infection
- •Concurrent prednisone or systemic steroid therapy
研究组 & 干预措施
Arm I: R-mabHDI and ABVD
干预措施: R-mabHDI and ABVD (Drug)
Arm II: ABVD
干预措施: ABVD (Drug)
结局指标
主要结局
The primary efficacy criterion is the response rates (RR) by Kaplan-Meier at 3,6,12, and 18 months.
时间窗: 18 months
次要结局
- Additional secondary endpoint criterion is the progress free survival (PFS) by Kaplan-Meier at 18 months.(18 months)