Donor Statin Treatment for Prevention of Severe Acute GVHD After Myeloablative Hematopoietic Cell Transplantation
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 83
- 试验地点
- 3
- 主要终点
- Grade 3-4 Acute GVHD
研究概览
简要总结
This phase II trial studies donor atorvastatin treatment for the prevention of severe acute graft-versus-host disease (GVHD) in patients undergoing myeloablative peripheral blood stem cell (PBSC) transplantation. Giving chemotherapy and total-body irradiation (TBI) before a donor PBSC transplant helps stop the growth of cancer cells. It may also prevent the patient's immune system reject the donor's stem cells. When the healthy stem cells from a donor are infused into the patient they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets. Sometimes the transplanted cells from a donor can make an immune response against the body's normal cells. Giving atorvastatin to the donor before transplant may prevent this from happening.
详细描述
PRIMARY OBJECTIVES:
I. To assess whether 2 weeks of donor statin treatment reduces the risk of severe acute GVHD.
SECONDARY OBJECTIVES:
I. To assess whether 2 weeks of statin treatment of normal PBSC donors is feasible, tolerable and safe.
OUTLINE:
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 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
- •Human leukocyte antigen (HLA)-identical sibling donor
- •Myeloablative preparative regimen (i.e., >= TBI 12.0 Gy, >= busulfan (BU) 8.0 mg/kg PO, >= BU 6.4 mg/kg intravenously (IV), >= treosulfan 42 g/m^2 IV) according to investigational study or standard treatment plan; other "myeloablative" preparative regimens are acceptable as long as they are approved by the principal investigator or designee
- •Transplantation of PBSC
- •Cyclosporine (CSP)-based postgrafting immunosuppression
- •Willingness to give informed consent
- •DONOR: Age >= 18 years
- •DONOR: HLA genotypically identical sibling
- •DONOR: Willingness to give informed consent
排除标准
- •Nonmyeloablative preparative regimen
- •Participation in an investigational study that has acute GVHD as the primary endpoint
- •The allogeneic PBSC donor has a contraindication to statin treatment
- •DONOR: Age < 18 years
- •DONOR: Active liver disease (alanine aminotransferase [ALT] or aspartate aminotransferase [AST] levels > 2 times the upper limit of normal [ULN])
- •DONOR: History of myopathy
- •DONOR: Hypersensitivity to atorvastatin
- •DONOR: Pregnancy
- •DONOR: Nursing mother
- •DONOR: Current serious systemic illness
- •DONOR: Concurrent treatment with strong inhibitors of hepatic cytochrome P450 (CYP) 3A4 (i.e. clarithromycin, erythromycin, protease inhibitors, azole antifungals)
- •DONOR: Current use of statin drug
- •DONOR: Failure to meet Fred Hutchinson Cancer Research Center (FHCRC) or local criteria for stem cell donation
- •DONOR: Total creatinine kinase > 2 times the ULN
研究组 & 干预措施
Supportive care (donor statin treatment)
Donors receive atorvastatin calcium PO beginning on day -14 and continuing until the last day of stem cell collection.
干预措施: Allogeneic Hematopoietic Stem Cell Transplantation (Procedure)
Supportive care (donor statin treatment)
Donors receive atorvastatin calcium PO beginning on day -14 and continuing until the last day of stem cell collection.
干预措施: Atorvastatin Calcium (Drug)
Supportive care (donor statin treatment)
Donors receive atorvastatin calcium PO beginning on day -14 and continuing until the last day of stem cell collection.
干预措施: Peripheral Blood Stem Cell Transplantation (Procedure)
结局指标
主要结局
Grade 3-4 Acute GVHD
时间窗: First 100 days after transplant
Cumulative incidence rate of grade 3-4 acute GVHD with death as a completing risk, assessed at day 100 in the patients/recipients.
次要结局
- Chronic Extensive GVHD(2 years post transplant)
- Proportion of Donors Who Have to Discontinue Atorvastatin Because of Toxicity(Until completion of stem cell collection (on average 14 days))
- Grades II-IV Acute GVHD(First 100 days after transplant)
- Recurrent or Progressive Malignancy(Up to 3 years)
- Disease-free Survival(1 year after transplant)
- Overall Survival(1 year after transplant)
- Non-relapse Mortality(At 1 year after HCT)
- Proportion of Patients Requiring Secondary Systemic Immunosuppressive Therapy(First 100 days after transplant)
研究者
Marco Mielcarek
Principal Investigator
Fred Hutchinson Cancer Center