Safety and Efficacy of Eltrombopag in Patients Undergoing Cord Blood or Haploidentical Bone Marrow Transplantation
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- Number of Participants That Achieved Platelet Engraftment Greater Than 50K/ul
研究概览
简要总结
This phase II trial studies how well eltrombopag olamine works in increasing platelet counts in patients undergoing transplant. Eltrombopag olamine may help platelet counts and the immune system recover from blood or bone marrow transplant.
详细描述
PRIMARY OBJECTIVES:
I. To estimate the rate of platelet engraftment by day 60 in patients undergoing cord blood transplant (CBT) or haploidentical donor stem cell transplantation treated with eltrombopag (eltrombopag olamine).
SECONDARY OBJECTIVES:
I. To assess safety of eltrombopag in this population. II. To assess neutrophil engraftment with eltrombopag in this population. III. To characterize immune reconstitution. IV. To assess overall survival (OS). V. To assess progression free survival (PFS). VI. To assess incidence of acute graft-versus-host disease (GVHD).
OUTLINE: Patients are assigned to 1 of 2 arms.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients undergoing a cord blood or haploidentical transplantation on any protocol or standard of care treatment plan.
- •Females of child bearing potential defined as not post-menopausal for 12 months or no previous surgical sterilization or breast-feeding must be willing to use an effective contraceptive measure until 30 days after the last dose of eltrombopag. Males who have had sexual contact with female of child-bearing potential must be willing to use contraceptive techniques until 30 days after the last dose of eltrombopag.
- •Patient or patient's legal representative(s) is/are able to provide written informed consent to participate.
排除标准
- •ALT and AST >/= 2.5 ULN.
- •Serum direct bilirubin >/= 1 mg/dl (except Gilbert's syndrome or hemolysis).
- •Patients of east Asian ancestry (Chinese, Japanese, or Korean Origin).
- •Calculated creatinine clearance < 30ml./min. Creatinine clearance will be calculated using the MDRD method.
- •Arterial or venous thrombosis in the last year except for line-related venous thrombosis more than 3 months ago.
- •Positive beta HCG within 7 days prior to consent in female of child-bearing potential defined as not post-menopausal for 12 months or no previous surgical sterilization or breast-feeding.
研究组 & 干预措施
Arm I (cord blood transplant patients)
Patients receive eltrombopag olamine PO QD for 60 days beginning on day -1.
干预措施: Eltrombopag Olamine (Drug)
Arm I (cord blood transplant patients)
Patients receive eltrombopag olamine PO QD for 60 days beginning on day -1.
干预措施: Laboratory Biomarker Analysis (Other)
Arm II (haploidentical donor stem cell transplant patients)
Patients receive eltrombopag olamine PO QD for 60 days beginning on day 5.
干预措施: Eltrombopag Olamine (Drug)
Arm II (haploidentical donor stem cell transplant patients)
Patients receive eltrombopag olamine PO QD for 60 days beginning on day 5.
干预措施: Laboratory Biomarker Analysis (Other)
结局指标
主要结局
Number of Participants That Achieved Platelet Engraftment Greater Than 50K/ul
时间窗: Up to day 60
Number of participants that achieved platelet engraftment greater than 50K/ul 60 days post transplant.
次要结局
- Progression Free Survival(Up to 1 year)
- Overall Survival(Up to 1 year)