A Comparison of Acute and Long-term Toxicities in Bone Marrow Donors With and Without G-CSF Treatment Prior to Harvest: A Companion Study to ASCT0631
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 13
- 试验地点
- 44
- 主要终点
- Percentage of Participants With Short-term Adverse Events in G-CSF (Filgrastim) Stimulated Bone Marrow (G-BM) Donors
研究概览
简要总结
This randomized clinical trial is studying the side effects of collection of bone marrow from donors treated with or without filgrastim. Giving colony-stimulating factors, such as filgrastim (G-CSF), to donors helps the stem cells move from the bone marrow to the blood so they can be collected and stored.
详细描述
PRIMARY OBJECTIVES:
I. To evaluate short- and long-term toxicities in bone marrow donors treated with vs without filgrastim before harvest.
II. To compare 10-year mortality and cancer in donors treated with vs without filgrastim.
SECONDARY OBJECTIVES:
I. To correlate the incidence of acute and chronic graft-vs-host disease in the marrow recipients enrolled on COG-ASCT0631 with four parameters assessed in the bone marrow harvests: absolute T-cell numbers, Th1 vs Th2 profile of T-cells, dendritic cell populations, and T-regulatory cell content.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Appropriately human leukocyte antigen (HLA)-matched (HLA, A, B, DRB1 identical or antigen mismatched [i.e., 5/6 or 6/6 antigens matched]) sibling of the bone marrow recipient enrolled on COG-ASCT0631
- •Adequate size relative to the recipient (i.e., harvesting the maximum of 20 cc/kg from the donor would result in a bone marrow graft that will provide an adequate cell and volume dose to the recipient, in the opinion of the treating physician)
- •Enrolled on the COG Umbrella Long-Term Follow-Up Study COG-ALTE05N1
- •Not pregnant or nursing
- •No human immunodeficiency virus (HIV) positivity
- •No sickle cell trait or sickle cell anemia/disease
- •Not at an increased risk from bone marrow donation after filgrastim administration due to a pre-existing medical condition, as determined by an independent physician separate from the research team
- •None of the following:
- •Active infection, especially pulmonary
- •Splenomegaly or a history of splenic injury
- •Active or recent pulmonary disease (i.e., pneumonia within the past 4 weeks)
- •A condition that would make the donor unsuitable to donate, as determined by an independent physician separate from the research team
- •No autoimmune disease
排除标准
- 未提供
结局指标
主要结局
Percentage of Participants With Short-term Adverse Events in G-CSF (Filgrastim) Stimulated Bone Marrow (G-BM) Donors
时间窗: Up to 1 year after donation
The Kaplan-Meier method will be used to estimate the cumulative incidence of short term adverse events defined by having any of the following events: 1) death due to a cause that is unknown or possibly related to G-CSF, 2) development of a malignancy, 3) development of a splenic rupture, or 4) development of a severe acute lung injury possibly related to GCSF therapy.
Percentage of Participants Who Experienced Death in G-CSF Stimulated-bone Marrow (G-BM) Donors
时间窗: Up to 1 year after donation
The Kaplan-Meier method will be used to estimate the cumulative incidence of death event in G-BM donors only.
Percentage of Participants With Grade 1 or 2 Toxicities
时间窗: Up to 1 year after donation
Estimate the percentage of patients having non-fatal complications of CTCAE Grades 1 or 2 in standard BM and G-CSF stimulated-bone marrow (G-BM) donors.
Percentage of Participants With Grade 3 or 4 Toxicities
时间窗: Up to 1 year after donation
Estimate the percentage of patients having non-fatal complications of Grade 3 other than pain (consider Grade 4 for pain only), or any of Grade 4 in standard BM and G-CSF stimulated-bone marrow (G-BM) donors. Modified Toxicity Criteria and Pain Assessment was used with higher grades corresponding to more severe AEs.
10-year Overall Cancer Incidence
时间窗: Up to 10 years post bone marrow harvest
The Kaplan-Meier method will be used to estimate overall cancer free probabilities in standard BM and G-BM donors.
10-year Mortality Rate in Marrow Donors
时间窗: Up to 10 years post bone marrow harvest
The Kaplan-Meier method will be used to estimate overall survival probabilities in standard BM and G-BM donors.
10-year Hematologic Cancer Rate
时间窗: Up to 10 years post bone marrow harvest
The Kaplan-Meier method will be used to estimate hematologic cancer probabilities in standard BM and G-BM donors.
次要结局
- Absolute T Cell Numbers(Up to 1 year after donation)
- Th1 vs. Th2 Profile of T Cells(Up to 1 year after donation)
- T Regulatory Cell Content(Up to 1 year after donation)
- Dendritic Cell (DC) Populations(Up to 1 year after donation)