NCT00144677已完成2 期
Open Label Phase II Trial of Sirolimus in Combination With Tacrolimus for Graft-vs-Host Disease Prophylaxis After HLA-Matched, Unrelated, Allogeneic Hematopoietic Stem Cell Transplantation
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- To determine the feasibility of using a combination of sirolimus and tacrolimus without methotrexate for GVHD prophylaxis after stem cell transplantation.
研究概览
简要总结
The purpose of this study is to evaluate the ability of sirolimus to prevent graft versus host disease (GVHD) in patients following stem cell transplant from an unrelated donor. This trial is designed to test the hypothesis that elimination of methotrexate in the unrelated donor group would lead to less transplant-related toxicity while still preserving the effective control of GVHD.
详细描述
- Therapy to prevent GVHD will consist of an infusion of tacrolimus intravenously and sirolimus orally once daily starting 3 days before stem cell infusion. This will take place in the hospital where the patient will remain for the duration of the transplant.
- Sirolimus will continue for approximately 100 days at a stable dose, then it will be tapered slowly over the course of weeks to months to prevent a flare in GVHD.
- Patients will be seen in the clinic weekly for the first 2 months after discharge from the hospital. If GVHD is present, tapering schedule will be slower and based on the patient's clinical condition.
- Tacrolimus will also be given orally after the patient is discharged and will be tapered on the same schedule as sirolimus.
- During the year following stem cell transplant, blood tests will be performed to evaluate the immune system and graft versus host disease.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Acute myelogenous leukemia(AML) in first or subsequent remission, in untreated first relapse or any treated relapse.
- •Acute lymphoblastic leukemia(ALL) in first or subsequent remission, in untreated first relapse or any treated relapse.
- •Chronic myelogenous leukemia in first or second chronic stable phase or in accelerated phase.
- •Myelodysplastic syndromes or myeloproliferative diseases
- •Non-Hodgkin's lymphoma or Hodgkin's disease in second or greater complete remission, in partial remission, or induction failure.
- •Chronic lymphocytic leukemia, Rai stage 2-4, which has progressed after initial therapy.
- •Matched unrelated donor.
- •Age 18-55 years at the time of stem cell transplantation
- •ECOG performance status 0-2
- •Life expectancy of 100 days without stem cell transplantation
- •Total bilirubin < 2.0 mg/dl
- •AST < 90 IU
- •Serum creatinine < 2.0 mg/dl
- •Ejection fraction > 40% by echocardiogram or gated nuclear medicine study.
排除标准
- •Uncontrolled infection
- •Forced vital capacity or DLCO < 50% predicted for age
- •Uncontrolled hypertension
- •Prior hematopoietic stem cell transplant
- •Evidence of HIV infection or active Hepatitis B or C infection
- •Cholesterol > 300 mg/dl
- •Relapsed aggressive Burkitt's or Burkitt's-like lymphoma
结局指标
主要结局
To determine the feasibility of using a combination of sirolimus and tacrolimus without methotrexate for GVHD prophylaxis after stem cell transplantation.
次要结局
- To compare the rates of grade II-IV and III-IV acute GVHD with historical control
- to determine the incidence of 100 day mortality using this GVHD prophylaxis regimen
- to determine the overall survival after one year of this patient population.
研究者
Corey S. Cutler, MD, MPH
Principal Investigator
Dana-Farber Cancer Institute
研究点 (2)
Loading locations...
相似试验
已完成
2 期
Sirolimus With Tacrolimus for Graft-vs-Host Disease Prophylaxis After Related Stem Cell TransplantationHematologic MalignanciesMyelogenous LeukemiaNon-Hodgkin's LymphomaHodgkin's DiseaseAcute Lymphoblastic LeukemiaMyelodysplastic SyndromeNCT00144703Dana-Farber Cancer Institute55
已完成
2 期
Sirolimus as Treatment of Steroid-Refractory or Steroid-Dependent Chronic Graft-Versus-Host DiseaseGraft vs Host DiseaseNCT00388362Stanford University36
终止
2 期
Topical Sirolimus Ointment for Cutaneous Angiofibromas in Subjects With Tuberous Sclerosis ComplexAngiofibroma of FaceTuberous SclerosisNCT03363763Aucta Pharmaceuticals, Inc24
终止
1 期
Treating Multiple Sclerosis With Sirolimus, an Immune System SuppressorMultiple Sclerosis (MS) - Relapsing-remittingNCT00095329National Institute of Allergy and Infectious Diseases (NIAID)14
已完成
3 期
Immunosuppression in Patients Undergoing Liver Transplantation for Hepatocellular CarcinomaHepatocellular CarcinomaNCT00355862University of Regensburg525