Does Maitake Mushroom Extract Enhance Hematopoiesis in Myelodysplastic Patients? A Phase II Trial
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- Changes in Neutrophil Counts
研究概览
简要总结
Researchers from Memorial Sloan-Kettering Cancer Center, in collaboration with The New York Presbyterian Hospital-Weill Medical College of Cornell University, are conducting a study of a medicinal mushroom extract called Maitake (pronounced my-tock-e).
Laboratory studies show that Maitake can reduce the growth of cancer in animals. The Maitake does not kill cancer cells directly. It is believed to work through the immune system (the body's defense system against infection). Our test tube, animal and human dose determining studies show that Maitake can enhance immune function. We are conducting this study to see whether Maitake improves the neutrophil count and function in patients with MDS. The neutrophils are white blood cells which help to fight infection.
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
- 是
入选标准
- •MSKCC patients age 18 or older able to sign informed consent
- •Absolute Neutrophil count >0.5 K/mcL
- •Diagnosis of MDS by bone marrow biopsy
- •Patient not a candidate for aggressive standard treatment
排除标准
- •IPSS (High risk)
- •History of AML
- •History of Stem Cell transplant
- •Known history of HIV+
- •Allergy to mushrooms
- •Bone Marrow blasts >10%
- •HEALTHY CONTROL ELIGIBILTY CRITERIA
- •Inclusion Criteria
- •Age ≥55 years
- •Exclusion Criteria
- •Currently taking corticosteroids or other immunosuppressants
- •Known history of HIV+
- •Current or previous malignancy or hematology disorder except adequately treated non-melanoma skin cancer, curatively treated in-situ cancer of the cervix, or other solid tumors curatively treated with no evidence of disease for > 3 years
研究组 & 干预措施
Maitake
This is a phase II trial examining hematopoietic response in MDS patients.
干预措施: Maitake (Drug)
结局指标
主要结局
Changes in Neutrophil Counts
时间窗: baseline and week 12
The main criterion for study response is ability of the study agent to show a statistically significant improvement in neutrophil count and neutrophil function (as measured by the respiratory burst test). Changes in neutrophil counts will also be described as defined by the International Working Group (IWG) criteria for response in MDS patients
次要结局
未报告次要终点