Therapeutic Use of Intravenous Vitamin C in Allogeneic Stem Cell Transplant Recipients
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 61
- 试验地点
- 1
- 主要终点
- The Proportion of Patients That Experience Non-relapse Mortality (NRM)
研究概览
简要总结
This phase 2 trial studies the effect of intravenous (IV) vitamin C repletion after myeloablative allogeneic stem cell transplant.
详细描述
Vitamin C is a nutritional supplement that can help fight inflammation. Most patients who have a stem cell transplant have lower than normal levels of vitamin C in their blood. Patients will receive intravenous Vitamin C the day after transplant for two weeks, followed by oral vitamin C until six months after transplant. The effect of the Vitamin C on non-relapse mortality (NRM), time to engraftment, rate of acute graft-versus-host disease and to characterize the safety and tolerability of the vitamin C regimen.
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 77 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •A patient must meet all of the following inclusion criteria to be eligible to participate in the study:
- •Any of the following hematological malignancies:
- •Acute lymphoblastic leukemia
- •Acute myelogenous leukemia
- •Chronic myelogenous leukemia
- •Myelodysplasia
- •Candidate for hematopoietic cell transplant (HCT) Note: Patients with or without previous myeloablative autologous transplant are eligible.
- •human leukocyte antigen (HLA) matched stem cell donor, either related (6/6 or 5/6 loci matched) or unrelated (8/8 or 7/8 loci matched)
- •Stem cell graft from either bone marrow or peripheral blood
- •Negative serology for HIV
- •Age ≥ 18 to < 78 years of age
- •Karnofsky Performance Status of 70-100%
- •Women who are not postmenopausal or have not undergone hysterectomy must have a documented negative serum pregnancy test per standard Massey Cancer Center- Virginia Commonwealth University Health System (MCC-VCUHS) Bone Marrow Transplant (BMT) Program guidelines
- •Ability to understand and the willingness to sign a written informed consent document. Note: The consent form must be signed and dated prior to initiation of stem cell transplant (SCT) preparative treatments.
排除标准
- •A patient who meets any of the following exclusion criteria is ineligible to participate in the study.
- •Known allergy to vitamin C
- •Inability to swallow oral medication
- •Known or suspected malabsorption condition or obstruction
- •G6PDH deficiency
- •Uncontrolled viral, fungal, or bacterial infection
- •Active meningeal or central nervous system disease
- •Alternative hematopoietic cell transplant (HCT) including haplo-identical and umbilical cord transplants
- •Non-myeloablative conditioning defined as total body irradiation (TBI) < 2 centigray (cGy)
- •Pregnancy or breastfeeding
- •Medical, psychological, or social condition that, in the opinion of the investigator, may increase the patient's risk or limit the patient's adherence with study requirements
研究组 & 干预措施
IV Vitamin C followed by oral Vitamin C
All study participants will receive the same treatment. Each participant will be given intravenous, which means by vein (IV), vitamin C three times a day for 14 days. Then participants will take vitamin C orally (by mouth in pill form) twice a day each day until 6 months after transplant. The treatment is IV vitamin C 50 mg/kg/day. After completion of the IV vitamin C doses, oral vitamin C 500 mg twice each day.
干预措施: Intravenous (IV) and oral Vitamin C (Drug)
结局指标
主要结局
The Proportion of Patients That Experience Non-relapse Mortality (NRM)
时间窗: 1 year following myeloablative allogeneic hematopoietic cell transplant (HCT)
To determine the effect of parenteral vitamin C on non-relapse mortality (NRM) at one year following myeloablative allogeneic HCT. Non-relapse mortality is defined as defined as mortality from complications of HCT but not tumor relapse, is usually from graft versus host disease (GVHD), infection, or organ failure.
次要结局
- Determine Related to Vitamin C Therapy Adverse Events (AEs) Reported Using Criteria in the National Cancer Institute Common Terminology Criteria for Adverse Events Version 5.0 (CTCAE v5.0)(Within first 30 days of myeloablative allogeneic HCT)
- Time From Transplant to Engraftment(30 Days after myeloablative allogeneic hematopoietic cell transplant (HCT))
- To Determine the Effectiveness of Reducing Acute Graft Versus Host Disease (aGVHD)(0 - 180 days after myeloablative allogeneic HCT)