Brentuximab Vedotin Plus AVD in Non-bulky Limited Stage Hodgkin Lymphoma
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 34
- 试验地点
- 4
- 主要终点
- Complete Response Rate
研究概览
简要总结
Brentuximab is an antibody-drug conjugate (ADC), which is the combination of an antibody (a protein that binds to cells) and a chemotherapy molecule. Brentuximab works by using the antibody portion to enter into the Hodgkin lymphoma cells and then releasing the chemotherapy portion, which attempts to destroy the cell.
The intravenous chemotherapy drugs Adriamycin, Vinblastine and Dacarbazine (AVD) which you will receive in this research study are approved for use in people with Hodgkin Lymphoma. A drug called bleomycin is usually included with AVD, but since it appears to be a less effective drug with significant potential risks, it is being replaced in this study with the drug brentuximab.
In this research study, the investigators are looking to see whether brentuximab in combination with AVD is effective in treating limited-stage Hodgkin Lymphoma.
详细描述
Each treatment cycle is 28 days. You will receive brentuximab alone on Day 1 and 15 of the first cycle (lead-in cycle). After cycle 1, you will receive brentuximab combined with AVD on Day 1 and 15 for 4-6 cycles, depending on your response to therapy. Brentuximab and AVD will be given to you by intravenous infusion (IV).
The following test and procedures will be performed on Days 1 and 15 of each cycle:
- Review of any side effects you have experienced and all medications you are taking
- Performance Status
- Physical exam and vital signs
- Routine blood tests
- Questionnaire to evaluate symptoms of neuropathy
- Research blood sample to look at markers to see how your body is responding to study medication
- PET-CT scan prior to completing cycle 2 of combination brentuximab/AVD
After the final dose of the study drug: The following assessments will be performed within one month of your last dose of study medication:
- Review of any side effects you have experienced and all medications you are taking
- Performance Status
- Physical exam and vital signs
- Routine blood tests
- Questionnaire to evaluate symptoms of neuropathy
- Research blood sample to look at markers to see how your body is responding to study medication
- PET-CT scan Follow up will include the following
- Review of any side effects you have experienced and all medications you are taking
- Performance Status
- Review and Physical exam
- Routine blood tests
- Questionnaire to evaluate symptoms of neuropathy
- CT scans
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Previously untreated stage IA, IB, IIA or IIB classical Hodgkin Lymphoma
- •Non-bulky disease defined as less than 10 cm in maximal diameter
- •Measurable disease greater than or equal to 1.5 cm
- •ECOG performance status of 0 or 2
- •Willing to use 2 effective forms of birth control
排除标准
- •No prior chemotherapy or radiotherapy for Hodgkin lymphoma
- •Not receiving any other investigational agents
- •No history of allergic reactions attributed to compounds of similar chemical or biologic composition to Adriamycin, Vinblastine, Dacarbazine or brentuximab
- •No pre-existing grade 3 or greater neuropathy
- •No uncontrolled intercurrent illness
- •Not pregnant or breastfeeding
- •No history of a different malignancy unless disease free for at least one year
研究组 & 干预措施
Treatment Arm
Brentuximab Vedotin in combination with Adriamycin, Vinblastine and Dacarbazine
干预措施: Brentuximab Vedotin (Drug)
Treatment Arm
Brentuximab Vedotin in combination with Adriamycin, Vinblastine and Dacarbazine
干预措施: Adriamycin, vinblastine, and dacarbazine (Drug)
结局指标
主要结局
Complete Response Rate
时间窗: End of Therapy (median duration of four months)
Complete response rate at the end of therapy as measured by Positron emission tomography-computed tomography (PET/CT). Response is evaluated using Revised International Working Group Criteria. Complete response is defined as disappearance of all evidence of disease.
次要结局
- Overall Response Rate After One Cycle of Brentuximab(28 days)
- Overall Response Rate(End of Therapy (median duration of four months))
- Grade III or IV Adverse Events(2 years)
研究者
Jeremy Abramson, MD
Principal Investigator
Massachusetts General Hospital