NCT00346359已完成2 期
Conditioning For Hematopoietic Cell Transplantation With Fludarabine Plus Targeted IV Busulfan and GVHD Prophylaxis With Thymoglobulin, Tacrolimus and Methotrexate in Patients With Myeloid Malignancies
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Incidence and severity of acute graft-versus-host disease (GVHD)
研究概览
简要总结
RATIONALE: Giving low doses of chemotherapy, such as fludarabine and busulfan, before a donor peripheral stem cell transplant helps stop the growth of abnormal and cancer cells. It also stops the patient's immune system from rejecting the donor's stem cells. The donated stem cells may replace the patient's immune system and help destroy any remaining abnormal or cancer cells (graft-versus-tumor effect). Sometimes the transplanted cells from a donor can also make an immune response against the body's normal cells. Giving antithymocyte globulin, tacrolimus, and methotrexate before or after transplant may stop this from happening.
PURPOSE: This phase II trial is studying how well giving fludarabine together with busulfan followed by donor peripheral stem cell transplant and antithymocyte globulin, tacrolimus, and methotrexate works in treating patients with myeloid cancer.
详细描述
OBJECTIVES:
Primary
- Determine the incidence and severity of acute graft-versus-host disease (GVHD) in patients with myeloid malignancies treated with conditioning regimen comprising fludarabine phosphate and busulfan followed by allogeneic peripheral blood stem cell transplantation and GVHD prophylaxis comprising antithymocyte globulin, tacrolimus, and methotrexate.
- Determine the incidence of donor engraftment in patients treated with this regimen.
Secondary
- Determine the pharmacokinetics of IV busulfan, including interdose variability and evaluation of a limited sampling strategy, in these patients.
- Determine the pharmacokinetics of antithymocyte globulin in these patients.
- Determine the pharmacokinetics of fludarabine phosphate and its effect on lymphocytes in these patients.
- Determine the incidence of specific toxic effects ≥ grade 3 in patients treated with this regimen.
- Determine the incidence and severity of chronic GVHD in these patients.
- Determine the incidence of nonrelapsing mortality at 100 days and at 1 year after transplantation in these patients.
- Determine the incidence of relapse in these patients.
- Determine relapse-free survival of these patients.
- Determine the incidence of Epstein-Barr virus activation in these patients.
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
- — 至 65 Years（Child, 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 myeloid malignancies:
- •Chronic myelogenous leukemia meeting 1 of the following criteria:
- •Chronic phase
- •Accelerated phase
- •Treated blast phase
- •Acute myeloid leukemia meeting 1 of the following criteria:
- •In remission
- •In early relapse, defined as < 10% marrow blasts
- •Myelodysplastic syndromes, including all risk groups
- •Other myeloproliferative disorders
- •HLA-A, -B, -C, -DRB1, and -DQB1 matched related or unrelated donor available
- •PATIENT CHARACTERISTICS:
- •No other disease that would severely limit life expectancy
- •AST ≤ 2 times normal
- •Creatinine ≤ 2 times normal OR creatinine clearance ≥ 60 mL/min
- •No cardiac insufficiency requiring treatment
- •No symptomatic coronary artery disease
- •PO_2 ≥ 70 mm Hg AND DLCO ≥ 70% of predicted OR PO _2 ≥ 80 mm Hg AND DLCO ≥ 60% of predicted
- •HIV negative
- •Not pregnant or nursing
- •Fertile patients must use effective contraception
- •PRIOR CONCURRENT THERAPY:
- •No post-transplantation growth factor during methotrexate administration
排除标准
- 未提供
结局指标
主要结局
Incidence and severity of acute graft-versus-host disease (GVHD)
Incidence of donor engraftment
次要结局
- Pharmacokinetics of IV busulfan including interdose variability and evaluation of a limited sampling strategy
- Pharmacokinetics of antithymocyte globulin
- Pharmacokinetics of fludarabine phosphate and its effect on lymphocytes
- Incidence of specific toxic effects ≥ grade 3
- Incidence and severity of chronic GVHD
- Incidence of nonrelapsing mortality at 100 days and at 1 year after transplantation
- Incidence of relapse
- Relapse-free survival
- Incidence of Epstein-Barr virus activation and post-transplantation lymphoproliferative disease
研究者
研究点 (2)
Loading locations...
相似试验
已完成
2 期
Reduced-Intensity Busulfan and Fludarabine With or Without Antithymocyte Globulin Followed by Donor Stem Cell Transplant in Treating Patients With Hematologic Cancer or Other DiseaseChronic Myeloproliferative DisordersMultiple Myeloma and Plasma Cell NeoplasmMyelodysplastic SyndromesLymphomaLeukemiaNCT00448201UNC Lineberger Comprehensive Cancer Center71
已完成
不适用
Donor Stem Cell Transplant in Treating Patients With Hematologic Cancer or Other DiseasesChronic Myeloproliferative DisordersMultiple Myeloma and Plasma Cell NeoplasmMyelodysplastic SyndromesLymphomaLeukemiaNCT00453206Wake Forest University Health Sciences66
已完成
2 期
Hematopoietic Stem Cell Transplantation in the Treatment of Infant LeukemiaMyelodysplastic SyndromesLeukemiaChildhood Acute Myeloid Leukemia in RemissionRecurrent Childhood Acute Myeloid LeukemiaSecondary Acute Myeloid LeukemiaChildhood Acute Lymphoblastic Leukemia in RemissionPreviously Treated Myelodysplastic SyndromeSecondary Myelodysplastic SyndromeRefractory Anemia With Excess Blasts in TransformationRefractory Anemia With Excess BlastsDe Novo Myelodysplastic SyndromeChildhood Myelodysplastic SyndromeRefractory AnemiaNCT00357565Masonic Cancer Center, University of Minnesota34
已完成
1 期
Allogeneic Hematopoietic Cell Transplantation for Patients With Busulfex-based RegimenChronic Myeloproliferative DisordersMultiple Myeloma and Plasma Cell NeoplasmMyelodysplastic SyndromesLymphomaLeukemiaNCT00448357UNC Lineberger Comprehensive Cancer Center54
已完成
1 期
Busulfan, Fludarabine, and Total-Body Irradiation in Treating Patients Who Are Undergoing a Donor Stem Cell Transplant for Hematologic CancerChronic Myeloproliferative DisordersMultiple Myeloma and Plasma Cell NeoplasmMyelodysplastic SyndromesMyelodysplastic/Myeloproliferative NeoplasmsPrecancerous ConditionLymphomaLeukemiaNCT00245037OHSU Knight Cancer Institute147