A Phase II Trial to Evaluate the Use of G-CSF-Mobilized Peripheral Blood Progenitor Cells as Hematopoietic Rescue in Patients With Acute Leukemia Undergoing Allografting From an Unrelated Donor
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: Transplanted peripheral stem cells can sometimes be rejected by the body's tissues. Treating donor peripheral stem cells with filgrastim may increase the number of donor white blood cells. This may help to decrease the rejection of the transplanted cells in patients receiving them as treatment for acute leukemia.
PURPOSE: Phase II trial to study the effectiveness of filgrastim-treated donor peripheral stem cells in treating patients with acute leukemia who are undergoing peripheral stem cell transplantation.
详细描述
OBJECTIVES:
- Determine whether filgrastim (G-CSF)-mobilized allogeneic peripheral blood stem cell transplantation reduces the incidence of non-leukemic mortality in patients with acute leukemia.
- Determine the kinetics and durability of engraftment after treatment with this regimen in these patients.
- Determine the incidence and severity of acute and chronic graft-versus-host disease in patients treated with this regimen.
- Determine the leukemia-free survival of patients treated with this regimen.
OUTLINE: Donors receive filgrastim (G-CSF) subcutaneously (SC) on days -5 to -1. Donors then undergo leukapheresis on days -1 and 0.
Patients undergo total body irradiation twice daily on days -7 to -4. Patients receive 2 doses of intrathecal methotrexate per local guidelines between days -10 and -3. Patients also receive cyclophosphamide IV on days -3 and -2. Patients receive infusion of allogeneic peripheral blood stem cells on day 0.
PROJECTED ACCRUAL: A total of 5-60 patients will be accrued for this study within 3 years.
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 55 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •One of the following diagnoses:
- •Primary acute leukemia beyond first remission
- •High-risk acute myelogenous leukemia
- •Acute lymphoblastic leukemia in first remission
- •Must have HLA-matched donor identical for HLA-A, -B, and DRB1 alleles
- •No HLA-matched identical sibling or haploidentical relative incompatible for 0 or 1 HLA-A, -B, or -DRB1 loci on the non-shared haplotype
- •No leukoencephalopathy
- •PATIENT CHARACTERISTICS:
- •55 and under
- •Performance status:
- •Not specified
- •Life expectancy:
- •Not specified
- •Hematopoietic:
- •Not specified
- •SGOT no greater than 2 times normal
- •Hepatitis B surface antigen negative
- •No prior hepatitis C
- •No impaired renal function
- •Creatinine less than 2 times normal
- •Cardiovascular:
- •No symptomatic cardiac disease
- •No active pulmonary disease
- •DLCO at least 60% predicted
- •HIV negative
- •No disease or other malignancy that severely limits life expectancy
- •No severe or life-threatening infection within the past 2 weeks
- •No history of septate fungal infection or disseminated candidiasis
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy:
- •No prior bone marrow or peripheral blood stem cell transplantation
- •Chemotherapy:
- •Not specified
- •Endocrine therapy:
- •Not specified
- •Radiotherapy:
- •No prior radiotherapy greater than 3,000 cGy to whole brain
- •No prior radiotherapy of 1,500 cGy to chest or abdomen
- •At least 6 months since prior involved-field radiotherapy to chest or abdomen
- •Not specified
排除标准
- 未提供