Hematopoietic Stem Cell Transplantation for the Treatment of Older Patients With Acute Myelogenous Leukemia
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 56
- 试验地点
- 1
- 主要终点
- Percentage of Participants With Relapse Free Survival at 1 Year
研究概览
简要总结
The prognosis for older individuals with acute myelogenous leukemia (AML) has been historically poor, with 2 year disease-free survival rates < 20% reported. Younger patients with AML in first complete remission are routinely treated using a full intensity (myelo-ablative) chemotherapy followed by a blood stem cell transplant. For the older patient with AML, full intensity therapy transplants have been greatly limited by increased rates of toxic effects related to this type of conditioning regimen. Reduced intensity (non-myeloablative) conditioning regimens have been used in a number of clinical settings, including AML therapy, to lessen the regimen related toxicity in the older patient. Recent data from the University of Michigan Blood and Marrow Transplant Program suggests improved survival for individuals > 55 years in age undergoing reduced intensity, transplants from unrelated donors. This study will investigate the safety and efficacy of this treatment option for older patients with AML, with the primary goal being to improve the survival and lifespan for older patients with AML.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 55 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •For Study Registration:
- •Age 55 - 70 years.
- •Subjects diagnosed with AML (> 20% myeloblasts).
- •For Proceeding to Transplant:
- •Subjects must be in either complete remission (CR) or partial remission (PR) within 14 days prior to admission.
- •Subjects must be > 21 days since completion of prior systemic chemotherapy or radiation therapy (including craniospinal XRT), prior to admission .
- •Organ function requirements for a reduced intensity (FluBu2) regimen (must be met within 21 days of admission):
- •Cardiac: LV Ejection Fraction > 40% on MUGA or Echocardiogram.
- •Pulmonary: FEV1 and FVC > 40% predicted, DLCO > 40% of predicted.
- •Renal: Serum creatinine < 2.0 mg/dl. Not on hemodialysis or continuous veno-venous filtration (CVVH).
- •Hepatic: serum total bilirubin < 3.0 mg/dl and AST / ALT < 4x ULN
- •Karnofsky > 60%.
- •Organ function requirements for a full intensity (FluBu4) regimen (must be met within 21 days of admission):
- •Cardiac: LV Ejection Fraction > 40% on MUGA or Echocardiogram.
- •Pulmonary: FEV1 and FVC > 50% predicted, DLCO (corrected for hemoglobin) > 50% of predicted.
- •Renal: serum creatinine < 2.0 mg/dl. Not on hemodialysis or continuous veno-venous filtration (CVVH)
- •Hepatic: serum total bilirubin < 3.0 mg/dl and AST / ALT < 4x ULN.
- •Karnofsky > 60%.
排除标准
- •For Study Registration:
- •Subjects with M3 AML (FAB classification)
- •For Proceeding to Transplant:
- •Subjects who exhibit signs of progressive disease (> 20% blasts) within 14 days prior to admission for transplant
- •Patients with an uncontrolled viral or fungal infection within the prior 28 days.
- •Patients who are HIV1 or HIV2 positive.
- •Uncontrollable medical or psychiatric disorder
研究组 & 干预措施
Fludarabine plus Busulfan (CR)
Patients in CR will receive a reduced intensity transplant regimen consisting of Fludarabine plus Busulfan (FluBu2).
干预措施: Fludarabine (Drug)
Fludarabine plus Busulfan (CR)
Patients in CR will receive a reduced intensity transplant regimen consisting of Fludarabine plus Busulfan (FluBu2).
干预措施: Busulfan (Drug)
Fludarabine plus Busulfan (CR)
Patients in CR will receive a reduced intensity transplant regimen consisting of Fludarabine plus Busulfan (FluBu2).
干预措施: Total Body Irradiation (Radiation)
Fludarabine plus Busulfan (CR)
Patients in CR will receive a reduced intensity transplant regimen consisting of Fludarabine plus Busulfan (FluBu2).
干预措施: Stem Cell Transplant (Procedure)
Fludarabine plus Busulfan (PR)
Patients in PR will receive a full intensity transplant regimen consisting of Fludarabine plus Busulfan (FluBu4).
干预措施: Fludarabine (Drug)
Fludarabine plus Busulfan (PR)
Patients in PR will receive a full intensity transplant regimen consisting of Fludarabine plus Busulfan (FluBu4).
干预措施: Busulfan (Drug)
Fludarabine plus Busulfan (PR)
Patients in PR will receive a full intensity transplant regimen consisting of Fludarabine plus Busulfan (FluBu4).
干预措施: Stem Cell Transplant (Procedure)
结局指标
主要结局
Percentage of Participants With Relapse Free Survival at 1 Year
时间窗: 1 year
The primary objective was to determine the 1 year relapse free survival rate (RFS) for individuals \> 55 years in age with Acute myeloid leukemia (AML) in Complete Remission (CR) or Partial Remission (PR) who undergo a 7-8/8 HLA- matched unrelated donor transplant using a reduced intensity regimen.
次要结局
- Percentage of Participants Alive at 1 Year(1 year)