Pilot Study of Telmisartan (Micardis) For the Prevention of Acute Graft vs. Host Disease Post Allogeneic Hematopoietic Stem Cell Transplantation
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Number of Subjects With Grade 3 or Greater Acute Graft vs. Host Disease (GVHD) in Patients Receiving Allogeneic HCT.
研究概览
简要总结
This is single-center, open-label, prospective study of telmisartan for the prevention of acute GVHD in approximately 60 subjects undergoing allogeneic HCT for treatment of a hematologic malignancy.
详细描述
This is single-center, open-label, prospective study of telmisartan for the prevention of acute GVHD in approximately 60 subjects undergoing allogeneic HCT for treatment of a hematologic malignancy. Subjects will receive 160 mg Micardis brand telmisartan once daily, starting 2 days prior to HCT (day -2). Once the patient is discharged post-HCT, treatment will continue through Day +98 post-HCT for a total of 101 days. After treatment discontinuation on or before day +98 post-HCT, subjects will be followed for up to 6 months for primary and secondary endpoints.
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 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of:
- •Acute myeloid or lymphoid leukemia in remission,
- •Myelodysplastic syndrome,
- •Chronic lymphoid leukemia,
- •Non-Hodgkin lymphoma,
- •Hodgkin lymphoma,
- •Chronic myeloid leukemia in chronic or accelerated phase,
- •Myeloproliferative disorder, or
- •Multiple myeloma
- •Undergoing allogeneic HSC transplantation from a related or unrelated donor matched at least at 7 of 8 of the HLA-A, -B, -C, and DR loci ("8/8" or "7/8" match)
- •Undergoing allogeneic HSC transplantation after a myeloablative TBI-, busulfan-, or (non-myeloablative) melphalan-based pre-transplant conditioning regimen. Regimens for transplantation will include at one of the following agents, given in conjunction with fludarabine or cyclophosphamide:
- •Busulfan 130 mg/m2 iv daily x 2 (reduced intensity) or 4 days
- •TBI 150 cGy bid x8 doses (1200 Gy)
- •Melphalan 140 mg/m
- •(Although melphalan is not a myeloablative regimen, it results in clinically significant mucositis and patients receiving this medication will be of considerable interest in the analysis of these data.)
- •Male or female patient age 18 years or older
- •Karnofsky performance status > 70% at time of initiation of pre-transplant conditioning
- •Transplantation-specific co-morbidity score of <5 at time of initiation of pre-transplant conditioning
- •Patients taking antihypertensive medications (including telmisartan) are eligible but the patient must discontinue treatment at least 48 hours prior to first dose of study medication
- •Capable of giving informed consent and having signed the informed consent form
排除标准
- •Inability to provide informed consent
- •Subjects with known heart failure, advanced renal impairment requiring renal replacement therapy, or liver failure although these patients would most likely not be eligible for HCT.
- •Subjects taking ACE inhibitors, potassium supplements, or spironolactone (or any other potassium-sparing diuretics) who cannot discontinue use prior to initiation of study treatment OR who require a high-potassium diet
- •Patient unable to discontinue current hypertension medication for medical or other reasons for two days prior to starting telmisartan
- •Chronic symptomatic hypotension, volume depletion.
研究组 & 干预措施
160 mg Telmisartan
60 patients will receive 160 of Telmisartan (2 80 mg tablets) for 101 days
干预措施: Telmisartan (Drug)
结局指标
主要结局
Number of Subjects With Grade 3 or Greater Acute Graft vs. Host Disease (GVHD) in Patients Receiving Allogeneic HCT.
时间窗: 100 days post-transplant
次要结局
- Number of Subjects With Grade III-IV Hypotension as Per the National Cancer Institute's Common Terminology(180 days post- transplant)