Phase II Multi-center Study of Resistant Potato Starch Plus Deferasirox to Improve Outcomes in Patients Undergoing Allogeneic Stem Cell Transplantation
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- GVHD-free and relapse-free survival
研究概览
简要总结
The study will evaluate the safety and early efficacy of administering the combination of a commercially available potato-based resistant starch along with iron chelation therapy to subjects undergoing alloHCT.
详细描述
The deferasirox intervention will begin one week prior to the RPS (Resistant Potato Starch) conditioning phase and both will continue through day +100. The study hypothesis is that a short-term administration of a resistant starch and iron chelation therapy will be capable of both increasing levels of butyrate within the intestine and restoring physiological hypoxia in the intestines, which together will reduce rates of acute GVHD (Graft versus Host Disease) and improve the clinically meaningful outcome of GRFS (Graft versus Host Disease / Relapse-Free Survival) at 12 months post-transplant.
21NOV2025- The grant previously listed on this trial is associated with the conduct of a preliminary study NCT02763033. Therefore, it was removed from this clinical trial as it is not being used for the conduct of this study.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with hematologic disorders undergoing allo-HCT from fully HLA-matched unrelated or related donors after full-intensity conditioning regimen
- •Age ≥18 years
- •Karnofsky performance status >70%, see Appendix A
- •Patients must be able to swallow capsules/tablets
- •Ability to understand and the willingness to sign a written informed consent
- •Availability of a full-HLA matched related or unrelated donor who is medically eligible to donate cells according to the National Marrow Donor Program criteria
排除标准
- •Patients with active inflammatory bowel disease requiring treatment per treating investigator
- •Patients with a history of gastric bypass surgery
- •Patients with active Clostridium difficile infection at the time of study enrollment. Active infection is defined as a stool sample positive for Clostridium difficile toxin via enzyme immunoassay (EIA) and either symptoms (frequent loose stools) OR imaging findings consistent with toxic megacolon
- •Patients with active iron deficiency anemia requiring treatment
- •Patients with iron overload receiving active treatment with deferasirox
- •Known hypersensitivity to deferasirox or any component of Jadenu or Exjade
- •Patients actively enrolled on treatment or in follow up phase on any other GVHD prevention trial
- •Any physical or psychological condition that, in the opinion of the investigator, would pose an unacceptable risk to the patient or raise concern that the patient would not comply with protocol procedures
研究组 & 干预措施
Study Treatment
All subjects will be enrolled into one arm and will be treated with RPS and Iron Chelation
干预措施: Iron chelation (Drug)
Study Treatment
All subjects will be enrolled into one arm and will be treated with RPS and Iron Chelation
干预措施: Potato Resistant Starch (Drug)
结局指标
主要结局
GVHD-free and relapse-free survival
时间窗: up to 1 year post- transplantation
Assessed in a time-to-event analysis, with GRFS defined as the first occurrence of grade III or IV acute GVHD, chronic GVHD warranting systemic immunosuppression, disease relapse or progression, or death from any cause.
次要结局
- Rates of grade II, III and IV acute GVHD(up to 1 year post- transplantation)
- Rates of chronic GVHD requiring systemic immunosuppression(up to 1 year post- transplantation)
- Length of event-free survival(up to 1 year post- transplantation)