NCT00005853已完成2 期
Therapy of Myelodysplastic Syndrome (MDS) With Antithymocyte Globulin (ATG) and TNFR:Fc
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 试验地点
- 1
研究概览
简要总结
RATIONALE: Biological therapies use different ways to stimulate the immune system and stop cancer cells from growing. Combining different types of biological therapies may kill more cancer cells.
PURPOSE: Phase II trial to study the effectiveness of biological therapy in treating patients who have myelodysplastic syndrome.
详细描述
OBJECTIVES:
- Determine the frequency of hematologic responses in patients with myelodysplastic syndrome treated with anti-thymocyte globulin and tumor necrosis factor receptor IgG chimera.
- Correlate phenotypic, cytogenetic, and functional disease characteristics with treatment responses in these patients.
- Determine the safety of this treatment regimen in this patient population.
OUTLINE: Patients receive anti-thymocyte globulin IV over 8 hours daily for 4 days followed by tumor necrosis factor receptor IgG chimera subcutaneously twice weekly for 16 weeks.
Patients are followed at 8, 16, and 20 weeks.
PROJECTED ACCRUAL: A total of 15 patients will be accrued for this study.
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Diagnosis of myelodysplastic syndrome with no greater than 20% marrow blasts with:
- •Single or multilineage cytopenia (neutrophils less than 2,000/mm^3 and/or platelet count less than 100,000/mm^3 and/or reticulocyte count less than 18,000/mm^3) OR
- •Transfusion requirement of at least 2 units packed red blood cells per month and one of the following:
- •Suitable marrow donor unavailable
- •Ineligible for a transplantation protocol
- •Unwilling to proceed with transplantation
- •No chronic myelomonocytic leukemia
- •PATIENT CHARACTERISTICS:
- •Performance status:
- •Not specified
- •Life expectancy:
- •Not specified
- •Hematopoietic:
- •See Disease Characteristics
- •Not specified
- •Not specified
- •No other severe disease that would preclude study
- •No active severe infection (e.g., pneumonia or septicemia) or severe infections within the past 2 weeks
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy:
- •See Disease Characteristics
- •At least 4 weeks since prior hematopoietic growth factors
- •No concurrent hematopoietic growth factors
- •Chemotherapy:
- •At least 4 weeks since prior cytotoxic therapy
- •No concurrent cytotoxic therapy
- •Endocrine therapy:
- •Not specified
- •Radiation therapy:
- •Not specified
- •Not specified
- •At least 4 weeks since prior immunomodulatory therapy
- •No concurrent immunomodulatory therapy
排除标准
- 未提供
研究者
研究点 (1)
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