A Pilot Study of Deferoxamine Before and During Myeloablative Allogeneic Stem Cell Transplantation for Patients With Myelodysplastic Syndromes or Acute Leukemia and Iron Overload
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 5
- 试验地点
- 2
- 主要终点
- Safety of Deferoxamine Therapy Determined by the Number of Participants With Grade 3 or Higher Toxicities.
研究概览
简要总结
The objective of this research study is to determine the safety and feasibility of chelation therapy with deferoxamine for patients with iron overload who are receiving a stem cell transplant. Patients who have iron overload prior to stem cell transplantation may have more toxicity from the transplantation procedure, and thus may benefit from an attempt at iron chelation pre- and peri-transplantation. In this study we are examining the use of deferoxamine starting 2 weeks to 3 months prior to transplantation and continuing through the preparative regimen.
详细描述
See above
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 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
- •18 years of age or older
- •Histologically confirmed acute myeloid leukemia, acute lymphoblastic leukemia, or myelodysplastic syndrome
- •Planned allogeneic stem cell transplantation with myeloablative conditioning regimen; the planned date of transplantation must be at least 4 weeks from time of enrollment
- •Severe iron overload as defined by BOTH: Ferritin greater than 1000ng/ml (at the time of donor availability) and Liver iron content estimated greater than or equal to 5mg/g dry weight by MRI (at the time of donor availability)
- •Patients with a history of prior autologous transplantation will be eligible for this study
排除标准
- •Contraindication to magnetic resonance imaging (MRI)
- •Creatinine >2.0mg/dl or creatinine clearance <50ml/min
- •Active uncontrolled bacterial or fungal infection
- •History of mucormycosis
- •Pre-existing clinically apparent retinal neuropathy. If patients have clinically apparent visual loss at the time of screening, they will be excluded if either they have known retinal neuropathy or if this cannot be excluded by further testing
- •Pre-existing clinically apparent sensorineural hearing loss. If patients have auditory loss at the time of screening, they will be excluded if either they have known sensorineural hearing loss, or if this cannot be excluded by further testing
- •Pregnancy or inability or unwillingness to use contraception during the time of the study
- •Lactating patients
- •Inability to provide informed consent
研究组 & 干预措施
All patients
Deferoxamine for >=2 weeks prior to stem cells
干预措施: deferoxamine (Drug)
结局指标
主要结局
Safety of Deferoxamine Therapy Determined by the Number of Participants With Grade 3 or Higher Toxicities.
时间窗: Baseline , 6 month, 1 year
All patients meeting the criteria for Severe iron overload as defined by BOTH: ferritin ≥ 1000 ng/ml and liver iron content(LIC) ≥ 5 mg/gdw were enrolled and received chelation therapy with Deferoxamine. All patients who received chelation therapy were monitored for grade 3 or above toxicity Attributable to Deferoxamine(grades defined by the CTCAE Version 3). The number of participants with grade 3 or higher toxicities were measured and used to determine the safety of chelation therapy.
次要结局
- 1-year Post-Transplant Survival(1 year)
研究者
Philippe Armand, MD, PhD
Principal Investigator
Dana-Farber Cancer Institute