NCT01530581已完成3 期
A Randomized Multicentre Study Comparing G-CSF Mobilized Peripheral Blood and G-CSF Stimulated Bone Marrow in Patients Undergoing Matched Sibling Transplantation for Hematologic Malignancies
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 230
- 试验地点
- 2
- 主要终点
- Efficacy
研究概览
简要总结
This is a Randomized Multicentre study Comparing GCSF Mobilized Peripheral Blood and GCSF stimulated Bone Marrow in Patients undergoing matched sibling Transplantation for Haematologic Malignancies.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 16 Years 至 65 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Recipient must
- •Be between the ages of 16 and 65 years old
- •Have one of the following hematologic malignancies:
- •Acute myeloid leukemia (de novo, secondary or therapy related) in untreated 1st relapse or in remission or with evidence of molecular relapse but blasts less than 5%
- •Chronic myeloid leukemia in chronic or accelerated phase (de novo or therapy related)
- •Myelodysplasia (de novo or therapy related)
- •Other hematologic malignancy (de novo or therapy related) including but not limited to: ALL (CR 1, CR2 or CR3), CLL, non-Hodgkin's lymphoma, Hodgkin's lymphoma
- •Must be receiving a myeloablative conditioning regimen of busulfan and cyclophosphamide or TBI and cyclophosphamide or other myeloablative regimen approved by the Clinical Study Chair. (Regimens containing ATG are not allowed.)
- •Have an HLA-identical sibling donor
- •Meet the transplant centre's criteria for myeloablative allogeneic transplantation*
- •Have an ECOG performance status of 0, 1 or 2
- •Have given signed informed consent
- •Be 18 years of age or older. (Upper age limit is at the discretion of the transplant physician at the collection centre.)
- •Be able to undergo general anesthesia and BM harvest or peripheral blood collection as per assessment by a transplant physician. (If an anesthetist assesses a donor after randomization and determines the donor should not undergo general anesthesia, then the donor and recipient will be withdrawn from the study.)
- •Be a sibling of the recipient
- •Be a 6/6 HLA match of the recipient. HLA typing is by serologic or DNA methodology for A and B and by DNA methodology for A and B and by DNA methodology for DRB1 (intermediate resolution)
- •Have given signed informed consent
- •Exclusion Criteria
- •The recipient is HIV antibody positive
- •The donor is unable to undergo general anesthesia, bone marrow harvest or peripheral blood collection
- •The donor is pregnant or breastfeeding at the time of progenitor cell collection
- •The donor has a history of malignant disease within the last 5 years or current malignancy other than non-melanomatous in situ skin carcinoma or cervical carcinoma in situ
- •The donor is HIV antibody positive
- •The donor has a known sensitivity to E. coli-derived products
- •The donor and recipient are identical twins
排除标准
- 未提供
研究组 & 干预措施
G-BM Transplant
Experimental
干预措施: G-BM Transplant (Procedure)
G-PB Transplant
Other
G-PB Transplant
干预措施: G-PB Transplant (Procedure)
结局指标
主要结局
Efficacy
时间窗: 2 years
The use of G-BM is associated with a longer time to treatment failure (extensive chronic GVHD, relapse, death) than is the use of G-PB for adult myeloablative allogeneic transplantation for hematologic malignancies.
次要结局
未报告次要终点
研究者
研究点 (2)
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