A Phase I/II Study of Immunologically Engineered rhG-CSF Mobilized Peripheral Blood Stem Cells (PBSC) for Allogeneic Transplant From HLA Identical, Related Donors for Treatment of Myeloid Malignancies
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Incidence of grade II, III, and IV graft-versus-host disease
研究概览
简要总结
RATIONALE: Giving chemotherapy drugs before a donor peripheral blood stem cell transplant helps stop the growth of cancer and abnormal cells and helps stop the patient's immune system from rejecting 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. Giving colony-stimulating factors, such as G-CSF, to the donor helps the stem cells move from the bone marrow to the blood so they can be collected and stored.
PURPOSE: This phase I/II trial is studying how well donor peripheral stem cell transplant works in treating patients with myelodysplastic syndrome, acute myeloid leukemia, or myeloproliferative disorder.
详细描述
OBJECTIVES:
- Determine the incidence of grades II, III, and IV graft-vs-host disease (GVHD) in patients with myelodysplastic syndromes (MDS), acute myeloid leukemia transformed from MDS, or myeloproliferative disorders treated with immunologically engineered, filgrastim (G-CSF)-mobilized, allogeneic peripheral blood stem cell transplantation.
- Determine the incidence of graft failure, relapse, and transplant-related mortality by day 100 in patients treated with this regimen.
- Determine the incidence of chronic GVHD, in terms of number and duration of immunosuppressant therapies, in patients treated with this regimen.
- Determine the feasibility of partial T-cell depletion in G-CSF-mobilized peripheral blood stem cells.
OUTLINE: Patients receive conditioning with oral busulfan every 6 hours on days -7 to -4 and cyclophosphamide IV on days -3 and -2. Immunologically engineered, filgrastim (G-CSF)-mobilized, allogeneic peripheral blood stem cells are infused on day 0.
Patients receive graft-vs-host disease prophylaxis comprising methotrexate IV on days 1, 3, 6, and 11 and cyclosporine IV over 1-4 hours (orally twice daily when tolerated) on days -1 to 80 and then gradually tapered over 5 months beginning on day 81.
Patients are followed regularly through day 100 and then at 1 year.
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Diagnosis of 1 of the following:
- •Myelodysplastic syndromes (MDS) that has advanced beyond refractory anemia (RA)
- •RA with excess blasts (RAEB) (greater than 5% blasts)
- •RAEB in transformation (greater than 20% but less than 30% blasts)
- •Acute myeloid leukemia (greater than 30% blasts) that evolved from MDS
- •Myeloproliferative disorder, including chronic myelomonocytic leukemia, agnogenic myeloid metaplasia, polycythemia vera, or essential thrombosis
- •No chronic myelogenous leukemia with or without excess (greater than 5%) blasts
- •Must have an HLA-identical, related donor
- •PATIENT CHARACTERISTICS:
- •Performance status
- •Not specified
- •Life expectancy
- •At least 6 months
- •Hematopoietic
- •Not specified
- •Bilirubin less than 2 times upper limit of normal (ULN)*
- •SGOT/SGPT less than 2 times ULN* NOTE: * Unless due to malignancy
- •Creatinine no greater than 2.0 mg/dL OR
- •Glomerular filtration rate at least 60 mL/min
- •Cardiovascular
- •Cardiac ejection fraction at least 45%
- •DLCO at least 60% of predicted
- •HIV negative
- •Human antimouse antibody negative
- •Not pregnant or nursing
- •Fertile patients must use effective contraception
- •No other medical condition that would preclude study participation
- •No hypersensitivity to cyclosporine
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy
- •No prior marrow transplantation
- •No concurrent growth factors for 21 days after study transplantation
- •Chemotherapy
- •Not specified
- •Endocrine therapy
- •Not specified
- •Radiotherapy
- •Not specified
- •Not specified
排除标准
- 未提供
结局指标
主要结局
Incidence of grade II, III, and IV graft-versus-host disease
次要结局
未报告次要终点