A Phase II Open Label, Multicenter, Randomized, Parallel Study Comparing the Efficacy of R-mabHD Alone and a Combination of Adriamycin, Bleomycin, Vinblastine and Dacarbazine (ABVD)in Treating Patients With Hodgkin's Disease.
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- There will be a reduction in the size of the tumor after initiating treatment.
研究概览
简要总结
120 subjects with Hodgkin's disease will be randomly divided into two groups: Group I receiving R-mabHD and Group II receiving a combination of Adriamycin,Bleomycin,Vinblastine and Dacarbazine. R-mabHD will be given once a week for eight weeks in a row. The ABVD combination will be given once every other week for 12 treatments. The hypothesis is that intervention with R-mabHD will lead to a quicker remission of Hodgkin's disease than the intervention with a combination of ABVD.
详细描述
The primary objective is to compare the efficacy of R-mabHD with a combination therapy of Adriamycin, Bleomycin,Vinblastine and Dacarbazine (ABVD) in bringing about remission of Hodgkin's lymphoma and reduction in tumor size.
Primary Study Endpoint: Primary efficacy criterion is percentage of patients achieving a functional score of 1.
Efficacy evaluation is based on assessment of functional score. At the end of six months, a functional assessment of the tumor will be undertaken to record the score as follows:
Score 1: >/= 50% reduction in size of tumor Score 2: < 50% reduction in size of tumor.
Secondary Study Endpoint: Additional secondary endpoint is the average time to achieve 50% reduction in size of tumor.
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
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Must sign an informed consent form
- •Must have histologically proven diagnosis of Hodgkin's lymphoma
- •Both genders and age between 18 and 65
- •Must have adequate bone marrow reserve (ANC.1500/mm3, Platelet>50,000/mm3)
- •Must have bidimensionally measureable disease
- •LVEF >50% by echocardiogram
- •Serum creatinine upto one fold
- •Serum bilirubin upto one fold
- •Hepatitis B surface antigen negative
- •Hodgkin's Disease patients who relapse after radiation therapy alone or surgical treatment alone or both,or previously untreated patients with stage II bulky, III and IV.
排除标准
- •HIV positive
- •Pregnant women and women of child bearing age who are not practising adequate contraception
- •Severe pulmonary disease including COPD and asthma
- •Evidence of other malignancy except superficial nonmelanoma skin carcinoma or carcinoma in situ of the cervix
- •Nursing mothers
- •Uncontrolled active infection
- •concurrent prednisone or other systemic steroid therapy
- •Less than 4 weeks since prior radiotherapy
- •Less than 30 days since prior investigational therapy.
研究组 & 干预措施
Arm I: R-mabHD
Anti-hodgkin disease agent
干预措施: R-mabHD (Drug)
Arm II: ABVD
干预措施: ABVD (Drug)
结局指标
主要结局
There will be a reduction in the size of the tumor after initiating treatment.
时间窗: Six months
次要结局
- There will be an improvement in the general condition of the patient and it will be possible to estimate the event free survival rate.(Eighteen months)