NCT01139164终止2 期
Allogeneic Hematopoietic Stem Cell Transplantation With Reduced-Intensity Pre-Transplant Conditioning for the Treatment of High-Risk Hematological Malignancies
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 78
- 试验地点
- 1
- 主要终点
- To Determine the Treatment-related Mortality Rate of Allogeneic Stem Cell Transplants Using Reduced-intensity Conditioning Regimens Within 1st 100-days.
研究概览
简要总结
This is study is for patients that have been diagnosed with high-risk hematological malignancies. The main purpose of this study is to confirm previously published results of stem cell transplantation with reduced intensity pre-transplant conditioning. Patients will be assigned to 1 of 3 regimens depending on the patient's diagnosis. Participants will be followed by the transplant team for the remainder of the patient's life. Patient's will visit MUSC daily, then visits will be reduced to frequent visits for up to 6 months. After 6 months, the visits will be reduced more depending on the patient's condition.
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
- 1 Year 至 75 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •A proven diagnosis of one of the conditions in Table
- •Prior therapy including blood or marrow transplant will not exclude patients for reduced intensity transplant.
- •Age < 75 years. Pediatric patients are eligible from the ages of 1 month to 18 years if the transplant physician believes that co-morbid conditions significantly increase the risk for a standard transplant regimen.
- •HIV antibody negative.
- •ECOG performance status 0-3, (or equivalent Karnofsky and Lansky performance scores for patients <18yrs, see appendix 2)
- •Availability of an HLA-identical related donor or suitable alternative donor, (≥7/8 allele match at A, B, C and DRB). Syngeneic transplants will not be allowed in this protocol.
- •Due to the complexity of the study, all patients prior to enrollment will be assessed by the PI or co-PI.
- •Patient with marrow failure states or immune deficiency syndromes undergoing stem cell transplants must be reviewed by one of the investigators to determine eligibility for study.
- •Adequate insurance coverage (or financial resources) to cover the costs associated with the patient's transplant and, in the case of patients eligible for cohort C, to cover the costs associated with I 131 Tositumomab treatment.
排除标准
- •Active CNS involvement with malignant disease.
- •Pregnancy.
- •Fertile men or women unwilling to use contraceptive techniques during the study period.
- •Creatinine clearance < 30 ml/min.
- •Left ventricular ejection fraction <30% or clinical cardiac failure uncontrolled by medical therapy.
- •Pulmonary disease requiring supplemental oxygen therapy.
- •Patients with estimated life span less than 1 year due to medical illnesses other than the condition being treated on the study.
- •Donor Selection:
- •Inclusion Criteria
- •Major HLA identical relative or genotypically matched unrelated donor (7-8/8 alleles) .
- •Donors must meet the selection criteria as defined by the Foundation for the Accreditation of Cell Therapy (FACT) and will be screened per the American Association of Blood Banks (AABB) guidelines.
- •Exclusion Criterion
- •Positive anti-donor HLA antibody.
- •Identical twin.
研究组 & 干预措施
Single Arm, non-randomized study
Experimental
干预措施: Regimen A (Drug)
Single Arm, non-randomized study
Experimental
干预措施: Regimen B (Drug)
Single Arm, non-randomized study
Experimental
干预措施: Regimen C (Drug)
结局指标
主要结局
To Determine the Treatment-related Mortality Rate of Allogeneic Stem Cell Transplants Using Reduced-intensity Conditioning Regimens Within 1st 100-days.
时间窗: 8 years
Number of subject deaths prior to day 100.
次要结局
- Morbidity of Allogeneic Stem Cell Transplants(100 days)
- To Determine the Engraftment Rate of Allogeneic Stem Cell Transplants(Day +100)
研究者
研究点 (1)
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