NCT01279252已完成2 期
A Phase II Trial of Broad Spectrum Antibiotic Therapy for Early Stage, Non-progressive Chronic Lymphocytic Leukaemia Without Adverse Prognostic Factors
King's College Hospital NHS Trust1 个研究点 分布在 1 个国家目标入组 71 人开始时间: 2011年7月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 71
- 试验地点
- 1
- 主要终点
- Overall response rate [Complete Remission (CR) + Partial Remission (PR)]
研究概览
简要总结
The purpose of this study is to evaluate whether patients with previously untreated, early stage CLL respond to empirical broad spectrum antibiotics and therefore test the hypothesis that occult bacterial infections are involved in the induction and maintenance of CLL.
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
- •Age > 18
- •ECOG performance status of 2 or less.
- •CLL with a diagnostic score of 4 or
- •Clinical stage A disease.
- •No disease progression over a minimum of 1 month prior to commencement of therapy.
- •Less than 2 adverse prognostic factors.
- •Absence of adverse cytogenetics.
- •Expected survival > 6 months.
- •Able to give informed consent.
- •No clinical evidence of active infection at the time of study entry.
- •No known allergy to any of the study medications.
- •Renal and liver function tests within normal limits.
排除标准
- •Disease progression during screening period.
- •Known positivity for HIV types 1 or
- •Active infection at the time of screening.
- •Pregnancy or lactation.
- •Females of childbearing potential† and males not willing to practice an effective method of contraception whilst receiving the antibiotic regimen and for 4 weeks after the last dose.
- •Concomitant medication likely to produce serious interaction with study drugs including warfarin type oral anticoagulants and anti-epileptics.
研究组 & 干预措施
Antibiotic regimen
Experimental
干预措施: metronidazole, clarithromycin, ciprofloxacin and lansoprazole (Drug)
结局指标
主要结局
Overall response rate [Complete Remission (CR) + Partial Remission (PR)]
时间窗: 6 months
次要结局
- Incidence of CTCAE grade 2 or above treatment related toxicity(From day 1 to 6 weeks)
- Bone marrow Minimal Residual Disease (MRD) status in patients who achieve CR(6 months)
研究者
研究点 (1)
Loading locations...
相似试验
撤回
2 期
Lenalidomide and Obinutuzumab for Previously Untreated CLLChronic Lymphocytic LeukemiaNCT02371590University of California, San Diego
终止
2 期
RESPeCT: Revlimid Early Stage Poor Prognosis Chronic Lymphocytic Leukaemia (CLL) TrialChronic Lymphocytic LeukaemiaNCT01127542The Christie NHS Foundation Trust1
已完成
1 期
Fludarabine/Rituximab Combined With Escalating Doses of Lenalidomide in Untreated CLLChronic Lymphocytic LeukemiaCLLNCT01703364Arbeitsgemeinschaft medikamentoese Tumortherapie12
招募中
2 期
DZD8586 in Patients With Relapsed or Refractory CLL/SLL (TAI-SHAN8)Chronic Lymphocytic Leukemia/Small Lymphocytic LymphomaNCT06539182Dizal Pharmaceuticals155
已完成
1 期
Safety and Tolerability Open Label Dose Escalation Study of Acadesine in B-CLL PatientsLeukemia, B-Cell, ChronicNCT00559624Advancell - Advanced In Vitro Cell Technologies, S.A.40