Total Marrow and Lymphoid Irradiation and Chemotherapy Prior to Allogeneic Hematopoietic Cell Transplant for High-Risk Acute Leukemia
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Progression-Free Survival (PFS)
研究概览
简要总结
RATIONALE: Giving chemotherapy and total marrow and lymphoid irradiation before allogeneic hematopoietic cell transplant helps stop the growth of leukemia cells. It may also stop the patient's immune system from rejecting the donor's stem cells. When the healthy stem cells from a donor are infused into the patient they may achieve brand new hematopoietic recovery. Sometimes the transplanted cells from a donor can make an immune response against the body's normal cells, resulting in graft versus-host disease.
PURPOSE: This study is to evaluate the toxicity and efficacy of total marrow and lymphoid irradiation conditioning when given together with combination chemotherapy and allogeneic peripheral blood stem cell transplant in treating patients with high-risk acute leukemia.
详细描述
Patient receives preparative therapy including cyclophosphamide and total body irradiation (TBI) of 10 Gy or total marrow and lymphoid irradiation (TMLI) of 12-20 Gy, and starts immunosuppressive therapy using cyclosporine or tacrolimus, methotrexate-based prophylaxes, followed by peripheral blood stem cell transplantation and granulocyte colony-stimulating factor administration.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 8 Years 至 65 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •High-risk acute myelogenous leukemia or acute lymphocytic leukemia based on clinical and biological characteristics, which including but not limited to poor response to induction therapy and relapse or beyond second remission.
- •Karnofsky performance status (KPS) >= 70%
- •Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control or abstinence) prior to study entry and for six months following duration of study participation; should a woman become pregnant or suspect that she is pregnant while participating on the trial, she should inform her treating physician immediately
- •All candidates for this study must have a prepared allogeneic stem cell donor, including human leukocyte antigen matched or partially mismatched donor
- •A cardiac evaluation with an electrocardiogram showing no ischemic changes or abnormal rhythm and an ejection fraction of >= 50% established by multi gated acquisition scan (MUGA) or echocardiogram
- •Patients must have a serum creatinine of less than or equal to 1.3 mg/dL or creatinine clearance >70 ml/min
- •Hepatic: bilirubin, aspartate aminotransferase (AST), alanine aminotransferase (ALT), Alkaline phosphatase (ALP) < 5 x upper limit of normal (ULN)
- •Pulmonary function: Carbon Monoxide Diffusing Capacity corrected (DLCOcorr) > 50% of normal, (oxygen saturation [>92%] can be used in child where pulmonary function tests (PFT's) cannot be obtained)
- •The time from the end last induction or re-induction attempt should be greater than or equal to 14 days
- •All subjects must have the ability to understand and the willingness to sign a written informed consent
排除标准
- •Active uncontrolled infection at time of enrollment or documented fungal infection within 3 months
- •Evidence of Human immunodeficiency virus (HIV) infection
- •Prior myeloablative transplant within the last 6 months
- •Prior radiation therapy that would exclude the use of TMLI
- •Relapsed patients who have undergone autologous or allogeneic hematopoietic stem cell transplantation previously
结局指标
主要结局
Progression-Free Survival (PFS)
时间窗: The time from start of protocol therapy to death, relapse/progression, or last follow-up, whichever comes first, assessed up to 2 years
Calculated using the Kaplan-Meier method. The cumulative incidence of relapse/progression will be calculated as a competing risk using the Gray method.
Incidence of toxicity, scored on National Cancer Institute Common Terminology Criteria version 4.03
时间窗: Up to 100 days after stem cell infusion
Toxicity information recorded will include the type, severity, and the probable association with the study regimen.
次要结局
- Incidence of transplantation-related mortality(6 months)
- Incidence of grade II-IV acute graft-versus-host disease (GVHD) after transplantation(Day +100)
- Incidence of chronic GVHD after transplantation(1 Year)
- Incidence of relapse after transplantation(1 year and 2 years)
- Overall survival after transplantation(The percentage of people in a study or treatment group who are alive for a certain period of time after they were diagnosed with or treated for a disease, such as cancer.)
- Menstrual recovery after transplantation(1 year and 2 years)
研究者
Chen Hu
Principal Investigator
Affiliated Hospital to Academy of Military Medical Sciences