Treatment of Graft Failure After Hematopoietic Stem Cell Transplantation
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Rate of donor engraftment
研究概览
简要总结
This is a guideline for the treatment of graft failure after hematopoietic stem cell transplant (HSCT). This regimen, consisting of cyclophosphamide and fludarabine with low dose total body irradiation (TBI) is designed to promote donor engraftment by day 42 after initial graft failure.
The graft will consist of bone marrow or G-CSF mobilized peripheral blood from a haploidentical related donor. The source of stem cells will be determined by the transplant team based on factors such as patient's age, medical history, donor availability and will be according to the current University of Minnesota Blood and Marrow Transplantation Program selection guidelines.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with primary or secondary graft failure, as defined below, may receive a second transplant:
- •Primary graft failure is defined as not achieving an ANC ≥0.5x10^9/L for three consecutive days by day 35 - 42 following the first transplant.
- •Secondary graft failure is defined as achieving an ANC ≥0.5x10^9/L for three consecutive days by day 35 - 42, but subsequently drops below 0.5x10^9/L without recovery.
- •Loss of chimerism is defined as achieving an ANC ≥0.5x10^9/L for three consecutive, but with less than 10% CD15+ donor cells in the marrow or peripheral blood.
- •Recipients should have acceptable organ function defined as:
- •Renal: creatinine < 2.0 (adults) and creatinine clearance >
- •For creatinine clearance < 70, consultation with a BMT pharmacist is necessary for chemotherapy dose adjustments.
- •Hepatic: bilirubin, AST/ALT, ALP < 10 x upper limit of normal
- •Cardiac: left ventricular ejection fraction > 40%
排除标准
- •Uncontrolled infection at the time of transplant.
- •Patients with Fanconi Anemia or other DNA breakage syndromes.
研究组 & 干预措施
Treatment
This regimen consists of cyclophosphamide and fludarabine with low dose total body irradiation (TBI), followed by hematopoietic stem cell infusion.
干预措施: Fludarabine (Drug)
Treatment
This regimen consists of cyclophosphamide and fludarabine with low dose total body irradiation (TBI), followed by hematopoietic stem cell infusion.
干预措施: Cyclophosphamide (Drug)
Treatment
This regimen consists of cyclophosphamide and fludarabine with low dose total body irradiation (TBI), followed by hematopoietic stem cell infusion.
干预措施: Total Body Irradiation (Radiation)
Treatment
This regimen consists of cyclophosphamide and fludarabine with low dose total body irradiation (TBI), followed by hematopoietic stem cell infusion.
干预措施: Hematopoietic stem cell infusion (Biological)
结局指标
主要结局
Rate of donor engraftment
时间窗: day 42
Rate of sustained donor engraftment at day 42 post this transplant.
次要结局
- Rate of treatment related mortality(day 100)
- Incidence of acute graft-versus-host disease(Day 100)
- Rate of survival(1 year)
- Incidence of chronic graft-versus-host disease(1 year)
- Rate of survival(Day 100)