NCT00101140撤回2 期
Phase II Study of Haploidentical Allogeneic Peripheral Blood Stem Cell Transplantation in Patients With High-Risk Acute Myeloid Leukemia in First Remission
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 撤回
研究概览
简要总结
RATIONALE: A peripheral stem cell transplant may be able to replace blood-forming cells that were destroyed by chemotherapy or radiation therapy. Sometimes the transplanted cells from a donor can make an immune response against the body's normal cells. Giving total-body irradiation together with fludarabine, thiotepa, and antithymocyte globulin before transplant may stop this from happening.
PURPOSE: This phase II trial is studying how well a donor stem cell transplant works in treating patients with acute myeloid leukemia in remission.
详细描述
OBJECTIVES:
Primary
- Determine the safety and antileukemia activity of haploidentical allogeneic peripheral blood stem cell transplantation in patients with high-risk acute myeloid leukemia in first remission.
Secondary
- Determine the early treatment-related mortality (before day 100) of patients treated with this regimen.
- Determine the incidence of acute graft-versus-host disease in patients treated with this regimen.
- Determine the incidence of graft failure in patients treated with this regimen.
- Correlate a mismatch in the expression of the natural killer cell inhibitory receptors CD158a and CD158b with engraftment and disease recurrence in patients treated with this regimen.
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
入排标准
- 年龄范围
- 18 Years 至 59 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Morphologically confirmed acute myeloid leukemia of 1 of the following subtypes:
- •Acute myeloblastic leukemia (M0, M1, M2)
- •Acute myelomonocytic leukemia (M4)
- •Acute monocytic leukemia (M5)
- •Acute erythroleukemia (M6)
- •Acute megakaryocytic leukemia (M7)
- •Must have 1 of the following karyotypic abnormalities at the time of diagnosis:
- •Complex cytogenetic abnormalities (≥ 3 cytogenetic clones)
- •Abnormalities of chromosome 5 [-5 or del(5q)]
- •Abnormalities of the long (q) arm of chromosome 3, 9, 11, 20, or 21
- •Abnormalities of the short (p) arm of chromosome 17, monosomy 7, t(9;22), or t(6;9) (8)
- •In morphologic first complete remission*, as evidenced by all of the following for ≥ 4 weeks before study entry:
- •Absolute neutrophil count > 1,000/mm^3
- •Platelet count > 100,000/mm^3
- •Leukemic blasts not present in the peripheral blood
- •Cellularity of bone marrow biopsy > 20% with maturation of all cell lines
- •Less than 5% blasts by bone marrow biopsy
- •No extramedullary leukemia, such as CNS or soft tissue involvement NOTE: *Reduced hemoglobin concentration or hematocrit has no bearing on remission status
- •Haploidentical (3/6 or 4/6 antigen matched [A, B, and DR]) family donor available
- •PATIENT CHARACTERISTICS:
- •Performance status
- •Life expectancy
- •Not specified
- •Hematopoietic
- •See Disease Characteristics
- •Bilirubin ≤ 2.0 mg/dL
- •AST < 2 times upper limit of normal
- •Creatinine ≤ 1.5 mg/dL
- •Cardiovascular
- •Ejection fraction > 40% by MUGA or echocardiogram
- •None of the following within the past 3 months:
- •Myocardial infarction
- •Significant congestive heart failure
- •Significant cardiac arrhythmia
- •FEV_1 and DLCO > 50% of predicted
- •Immunologic
- •HIV negative
- •No active or unresolved infection
- •No evidence of invasive fungal infection (e.g., positive blood or deep tissue cultures or stains)
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception
- •No organ damage
- •No other medical problem that would preclude study participation
- •No other currently active tumor that would likely interfere with study treatment or that would likely compromise the patient's morbidity or mortality
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy
- •No concurrent routine use of filgrastim (G-CSF) or sargramostim (GM-CSF) to accelerate hematopoietic recovery post-transplantation
- •Chemotherapy
- 另有 6 项未显示
排除标准
- 未提供
研究者
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