Pilot Study of Abbreviated Chemotherapy Based on Positron Emission Tomography in Hodgkin Lymphoma
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 6
- 试验地点
- 1
- 主要终点
- 36-Month Progression-free Survival Rate
研究概览
简要总结
The primary objective of the study is to determine the progression-free survival [PFS] at 36 months for patients with Hodgkin lymphoma who achieve a complete metabolic response as demonstrated by a negative fluorodeoxyglucose (FDG)-PET scan after one cycle of ABVD (adriamycin, bleomycin, vinblastine, dacarbazine) who undergo abbreviated ABVD chemotherapy (3 cycles).
详细描述
The proposed study is based on the repeated demonstration that patients with Hodgkin lymphoma who attain a negative PET scan early in therapy (after one or 2 cycles of chemotherapy) have a uniformly excellent outcome, with long term disease free survival of 90-95%. We propose to abbreviate chemotherapy in those patients showing a complete metabolic response as measured by FDG-PET after one cycle of ABVD. These patients will undergo two more cycles of ABVD chemotherapy, for a total of 3 cycles. Those patients failing to achieve a complete metabolic response as demonstrated by residual FDG avidity will go off study and be treated as per their primary treating physician.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically documented classical Hodgkin lymphoma according to the WHO Classification. Nodular lymphocyte predominant Hodgkin lymphoma is excluded
- •No prior treatment (chemotherapy or radiation therapy) for Hodgkin lymphoma
- •Measurable disease must be present either on physical examination or imaging studies. Any tumor mass measurable in two dimensions and > 2 cm is acceptable (or 1.5 cm if 0.5 cm slices are used as in spiral CT scans)
- •Patients must have at least one hypermetabolic lesion identifiable on initial PET scan
- •LVEF by ECHO or MUGA within institutional normal limits
- •Initial laboratory data should be compatible with the administration of standard doses of ABVD chemotherapy
排除标准
- •Patient has no known HIV infection
- •Patient is non-pregnant and non-lactating. Due to the teratogenic potential of the agents used in this study, pregnant or nursing women may not be enrolled. Women and men of reproductive potential should agree to use an effective means of birth control
- •No other history of lymphoproliferative disorder or granulomatous disease
研究组 & 干预措施
Early Stage Disease
Group A
干预措施: ABVD chemotherapy (Drug)
Advance Stage Disease
Group B
干预措施: ABVD chemotherapy (Drug)
结局指标
主要结局
36-Month Progression-free Survival Rate
时间窗: 36 months
Progression-free survival is defined as the length of time from study intervention to disease progression or death
次要结局
未报告次要终点