NCT01468740Unknown2 期
A Prospective Multicenter Study on HIV-associated Hodgkin Lymphoma
Harlachinger Krebshilfe e.V.16 个研究点 分布在 1 个国家目标入组 130 人开始时间: 2004年3月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 130
- 试验地点
- 16
- 主要终点
- Number of patients with World Health Organization (WHO) grade 3 and grade 4 toxicity
研究概览
简要总结
Standard therapy for HIV-related Hodgkin lymphoma (HIV-HL) has not been defined. This trial was initiated to investigate a risk adapted treatment strategy in patients (pts) with HIV-HL as established in HIV-negative patients with HL.
Treatment schedule:
- Early stage favorable Hodgkin Lymphoma (HL): 2 cycles of doxorubicin, bleomycin, vinblastine, and dacarbazine (ABVD) plus 30 Gy involved field (IF) radiation
- Early stage unfavorable HL: 4 cycles of bleomycin, etoposide, doxorubicin, cyclophosphamide, vincristine, procarbazine, and prednisone (BEACOPP)-baseline or 4 cycles of ABVD plus 30 Gy IF radiation
- Advanced HL: 8 cycles of BEACOPP-baseline. BEACOPP should be replaced by ABVD in pts with far advanced HIV-infection. After the completion of chemotherapy sites of initial bulky disease (those at least 5 cm in diameter) and residual tumor larger than 2.5 cm in diameter receive 30 Gy of irradiation.
- Primary outcome measure: tolerability, treatment-related mortality
- Secondary outcome measure: complete remission rate, progression-free survival (PFS), overall survival (OS).
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age 18 - 75 years
- •proven infection with HIV 1 (Elisa and Western Blot)
- •histology-proven newly diagnosed Hodgkin lymphoma
- •written, informed consent.
排除标准
- •severe cardiac, hepatic or pulmonary insufficiency
- •severe renal insufficiency (creatinine > 2,0 mg/dl) not caused by lymphoma
- •bone marrow failure, not caused by lymphoma or HAART (neutrophils < 1000/µl, platelets < 70.000/µl)
- •uncontrolled infection
- •uncontrolled drug addiction or psychiatric disease
- •pregnancy or lactation period
- •prior chemotherapy of Hodgkin lymphoma
- •life expectancy < 6 weeks
- •HIV-related wasting-syndrome
- •active secondary malignancy with cervix carcinoma in situ, basalioma and Kaposi's sarcoma being excepted
结局指标
主要结局
Number of patients with World Health Organization (WHO) grade 3 and grade 4 toxicity
时间窗: 30 days after termination of chemotherapy or radiotherapy
Treatment related mortality
时间窗: 30 days after termination of chemotherapy or radiotherapy
次要结局
- Overall Survival(12 months and 24 months after termination of chemotherapy or radiotherapy)
- Progression-free survival(12 months and 24 months after termination of chemotherapy or radiotherapy)
- Complete remission rate(30 days and 90 days after termination of chemotherapy or radiotherapy)
研究者
研究点 (16)
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