Phase II Study of a Geriatric Assessment-Driven, Risk-Adapted Allogeneic Hematopoietic Cell Transplant Strategy for Older Patients With Myeloid Malignancies
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 33
- 试验地点
- 7
- 主要终点
- cumulative incidence of non-relapse mortality (NRM)
研究概览
简要总结
This study will evaluate whether a geriatric assessment can lead to better treatment outcomes in older patients (age 60+) with a myeloid malignancy including acute myeloid leukemia, ,myelodysplastic syndromes, myeloproliferative neoplasms, or related blood disorders who are going to receive chemotherapy or another treatment to prepare the body for an allogeneic hematopoietic stem cell transplant (allo-HCT). The geriatric assessment includes looking at patients' cognitive function (thinking processes), physical function, mobility (ability to move the body), mood, nutrition, and current medications to help decide the type of treatment they'll receive.
Another purpose of this study is to see whether use of the geriatric assessment improves participants' quality of life. We will evaluate participants' quality of life through questionnaires.
详细描述
This is a prospective, phase II study evaluating the efficacy of a risk-adapted, personalized allo-HCT strategy based on geriatric vulnerabilities identified by pre-transplant GA. The less vulnerable/fit older patients are recommended to receive MA conditioning and the more vulnerable older patients are recommended to receive RIC/NMA conditioning.
- HCT-CI/Age ≤4 AND no IADL impairment (less vulnerable/fit) -> MA regimen
- HCT-CI/Age >4 AND/OR any IADL impairment (more vulnerable) -> RIC/NMA regimen
- Chemotherapies: busulfan, fludarabine, melphalan, cyclophosphamide, thiotepa, clofarabine
- Radiation therapy: total body irradiation (TBI)
- Other therapy: anti-thymocyte globulin (ATG)
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •are 60 years or older
- •have a pathologically confirmed myeloid malignancies including acute myeloid leukemia, ,myelodysplastic syndrome, myeloproliferative neoplasms, or related blood disorders including chronic myelomonocytic leukemia, atypical chronic myeloid leukemia, and myelodysplastic/myeloproliferative overlapping syndrome
- •have <10% blasts in bone marrow prior to transplant
- •have a matched related or unrelated donor, mismatched unrelated donor, or haploidentical donor
- •Meet institutional standard criteria for allogeneic transplantation as determined by the primary transplant physician
- •Undergoes transplantation using the allocated conditioning regimen intensity defined by the protocol-specified criteria below:
- •HCT-CI/Age <5 and IADL normal = myeloablative regimen
- •HCT-CI/Age ≥5 and/or IADL impairment = RIC/NMA regimen
排除标准
- •Prior hematopoietic cell transplantation
- •Cord blood donors
- •Persons with active, refractory disease defined by ≥10% blasts in bone marrow prior to transplant
研究组 & 干预措施
Geriatric participants with various blood disorders
- Geriatric assessment (GA) pre-transplant
- Risk-adapted allocation of conditioning intensity based on GA
- GA-directed, longitudinal supportive care management
干预措施: Geriatric assessment (GA) pre-transplant (Other)
Geriatric participants with various blood disorders
- Geriatric assessment (GA) pre-transplant
- Risk-adapted allocation of conditioning intensity based on GA
- GA-directed, longitudinal supportive care management
干预措施: conditioning regimen (Drug)
Geriatric participants with various blood disorders
- Geriatric assessment (GA) pre-transplant
- Risk-adapted allocation of conditioning intensity based on GA
- GA-directed, longitudinal supportive care management
干预措施: Allogeneic CD34+ selected stem cells (Procedure)
结局指标
主要结局
cumulative incidence of non-relapse mortality (NRM)
时间窗: 1 year
defined as death in the absence of relapse/disease progression.
次要结局
未报告次要终点