Safety and Efficacy of Maraviroc, a CCR5-inhibitor in Prophylaxis of Graft-Versus-Host Disease in Patients Undergoing Non-Myeloablative Allogeneic Stem-Cell Transplantation
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 38
- 主要终点
- Safety of Maraviroc
研究概览
简要总结
This study investigates the effectiveness and safety of Maraviroc (an oral medication given twice daily given in addition to the standard GVHD prophylaxis) in preventing Graft versus Host Disease (GVHD) in patients undergoing non-myeloablative allogeneic stem-cell transplantation (SCT). Subjects will receive Maraviroc bid (in addition to standard GVHD prophylaxis) beginning after the last dose of the chemotherapy conditioning regimen until day 30 after stem-cell infusion.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 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
- •patients scheduled to undergo non-myeloablative allogeneic stem-cell transplantation.
- •meet institutional eligibility criteria for allogeneic SCT. Significant criteria are:
- •Renal function: Serum creatinine <2; or calculated creatinine clearance > 40 mL/min/1.72m2;
- •Hepatic function: Baseline direct bilirubin, ALT or AST lower than three times the upper limit of normal;
- •Pulmonary disease: FVC or FEV1 > 40% predicted; Cardiac ejection fraction > 40%.
排除标准
- •Patients not expected to be available for follow-up in our institution for at least 100 days after the transplant
- •Patients who are not undergoing standard non-myeloablative SCT with Flu/Bu conditioning and Tax/MTX GVHD prophylaxis
- •Patients with uncontrolled bacterial, viral or fungal infections
- •Patients who take strong inducers or inhibitors of the CYP450A4
- •Patients receiving other investigational drugs for GVHD
- •Women who are pregnant, plan to become pregnant or are breastfeeding
研究组 & 干预措施
Phase 1: 150mg Maraviroc
150mg twice daily
干预措施: Maraviroc 150 MG (Drug)
Phase 1: 300mg Maraviroc
300mg twice daily
干预措施: Maraviroc 300 mg (Drug)
Phase 2: 300mg Maraviroc
300mg twice daily
干预措施: Maraviroc 300 mg Phase II (Drug)
结局指标
主要结局
Safety of Maraviroc
时间窗: 1 year
number of Adverse Events following exposure to Maraviroc
Efficacy of Maraviroc
时间窗: 8 weeks
Efficacy is measured by number of participants progressing to acute GVHD. If acute GVHD is noted in a participant following exposure to study drug, then efficacy was not achieved. If no GVHD was noted following exposure, then efficacy was achieved in that participant
次要结局
- Number of Patients Treated With Maraviroc During SCT That Develop Chronic GVHD(1 year)
- Number of Participants Who Relapsed During Study Period(1 year and 11 months)
- Pharmacokinetic Profile of Maraviroc in Patients Undergoing Nonmyeloablative Allogeneic SCT(pre-dose, 1,2,3,4,6,12 hours post-dose)
- Rate of Early Mortality After Transplant(1 year)