NCT00089037已完成1 期
A Phase I/II Study of Sirolimus in Addition to Tacrolimus and Methotrexate for the Prevention of Acute-Graft-Versus-Host Disease in Patients Undergoing Hematopoietic Stem Cell Transplantation From Unrelated Donors
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 试验地点
- 1
研究概览
简要总结
RATIONALE: Sirolimus, tacrolimus, and methotrexate may be effective in preventing acute graft-versus-host disease in patients who are undergoing donor stem cell transplantation.
PURPOSE: This phase I/II trial is studying the side effects of sirolimus when given together with tacrolimus and methotrexate and to see how well they work in preventing acute graft-versus-host disease in patients who are undergoing donor stem cell transplantation for hematologic cancer.
详细描述
OBJECTIVES:
Primary
- Determine the safety and efficacy of sirolimus when administered with tacrolimus and methotrexate for the prevention of acute graft-versus-host disease (GVHD) in patients with hematological malignancies undergoing hematopoietic stem cell transplantation from unrelated donors.
Secondary
- Determine the absorption and pharmacokinetics of sirolimus in patients treated with this regimen.
- Correlate sirolimus blood concentration with prevention of GVHD or toxicity in patients treated with this regimen.
- Determine the severity of post-transplantation mucositis in patients treated with this regimen.
研究设计
- 研究类型
- Interventional
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Diagnosis of hematological malignancy
- •No chronic phase chronic myelogenous leukemia, de novo acute leukemia in first remission, or myelodysplastic syndromes with refractory anemia
- •Scheduled for hematopoietic stem cell transplantation from unrelated donors
- •Currently receiving conditioning regimen comprising cyclosporine and total body radiotherapy (1,200 to 1,350 cGy) or busulfan and cyclosporine
- •Donor must be typed to the highest level of resolution
- •One single non-serologic disparity for A, B, or C alleles allowed provided the disparity is within the third or fourth digit of the allele
- •No mismatch at DRB1 or DQB1
- •PATIENT CHARACTERISTICS:
- •Per primary treatment protocol
- •Performance status
- •Not specified
- •Life expectancy
- •Not specified
- •Hematopoietic
- •Not specified
- •SGOT and SGPT ≤ 2.0 times upper limit of normal
- •Bilirubin normal
- •Hepatitis B and C virus negative
- •Creatinine clearance ≥ 70 mL/min
- •Cardiovascular
- •No cardiac insufficiency requiring treatment
- •No coronary artery disease
- •No acute pulmonary infection by chest x-ray
- •No severe hypoxemia with pO_2 < 70 mm Hg AND DLCO < 70% of predicted
- •No mild hypoxemia with pO_2 < 80 mm Hg AND DLCO < 60% of predicted
- •Not pregnant or nursing
- •Negative pregnancy test
- •HIV negative
- •No active systemic infection
- •No known hypersensitivity to macrolide antibiotics (e.g., erythromycin, azithromycin, or clarithromycin)
- •No prior intolerance or unresponsiveness to sirolimus
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy
- •See Disease Characteristics
- •No concurrent T-cell depleted transplantations
- •Chemotherapy
- •See Disease Characteristics
- •Endocrine therapy
- •Not specified
- •Radiotherapy
- •See Disease Characteristics
- •Not specified
- •No concurrent grapefruit juice
- •No concurrent voriconazole
排除标准
- 未提供
研究者
研究点 (1)
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