NCT01418430已完成4 期
HTLV-I Associated Adult T-cell Leukaemia/Lymphoma (ATLL) Pilot Study of Combination Therapy With CHOP-Zenapax (CHOP-daclizumab)
King's College Hospital NHS Trust1 个研究点 分布在 1 个国家开始时间: 2011年8月17日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 试验地点
- 1
研究概览
简要总结
The purpose of this study is to determine the safety of the combination of CHOP plus daclizumab in patients with ATLL previously untreated with anthracycline based chemotherapy.
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
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
- •Histologically confirmed ATLL requiring treatment
- •Frank acute leukaemia or lymphoma subtypes
- •Chronic and smouldering cases should be considered if they are symptomatic and require therapy, or there is evidence of disease progression
- •No previous treatment with anthracycline based cytotoxic chemotherapy
- •a. Patients may have received interferon and /or zidovudine and/or non-anthracycline based therapy
- •Age 18-75 years
- •Written informed consent
排除标准
- •HIV 1 or 2 positivity
- •Pregnancy or breast-feeding
- •Concomitant chemo-radiotherapy
- •Prior hepatic or renal insufficiency with a bilirubin or transaminases greater than 5 times the normal range or a creatinine greater than 150μmol/l (not related to hypercalcaemia) following rehydration
- •Other concomitant neoplasms not related to HTLV-I
- •Cardiac or respiratory insufficiency with an ECOG score of greater than 3
- •Any serious active uncontrolled infection
研究组 & 干预措施
CHOP-daclizumab
Experimental
干预措施: CHOP-daclizumab (Drug)
研究者
研究点 (1)
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