NCT02200380终止2 期
A Pilot Study of CDX-301 (rhuFlt3L) With or Without Plerixafor for the Mobilization and Transplantation of Allogeneic Blood Cell Grafts in HLA-Matched Donor/Recipient Sibling Pairs
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 36
- 试验地点
- 8
- 主要终点
- Safety and tolerability profile of CDX-301 with or without plerixafor in healthy adult sibling stem cell donors.
研究概览
简要总结
This is an open-label, multicenter, prospective pilot study of CDX-301 with or without plerixafor as a stem cell mobilizer for allogeneic transplantation (stem cells that come from another person). HLA-matched sibling healthy volunteers (donors) and patients with protocol specified hematologic malignancies (recipients) will be enrolled.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Read, understood and provided written informed consent and willing to comply with all study requirements and procedures
- •6 out of 6 HLA-matched sibling
- •Negative test for human immunodeficiency virus (HIV), hepatitis B, and hepatitis C
- •Both male and female patients of childbearing potential enrolled in this trial must use adequate birth control measures
- •Subjects should be in generally good health and without significant medical conditions, based upon pre-study medical history, physical examination, electrocardiogram (ECG), chest X- ray, and laboratory tests
- •Meets all criteria to serve as a mobilized blood cell donor in accordance with all applicable individual Transplant Center criteria
- •Read, understood and provided written informed consent and willing to comply with all study requirements and procedures
- •6 out of 6 HLA-matched sibling
- •Both male and female patients of childbearing potential enrolled in this trial must use adequate birth control measures
- •Diagnosis of one of following:
- •Acute Myelogenous Leukemia (AML) in 1st remission or beyond
- •Acute Lymphoblastic Leukemia (ALL) in 1st remission or beyond
- •Chronic Myelogenous Leukemia (CML)
- •Chronic Lymphoblastic Leukemia (CLL), relapsing after at least one prior regimen
- •Myelodysplastic Syndrome (MDS), either intermediate 1,2, or high risk by IPI Scoring System or transfusion dependent
- •Non-Hodgkins Lymphoma (NHL) or Hodgkins Disease (HD) in 2nd or greater complete remission, partial remission, or in relapse
- •Meets all criteria to serve as a transplant recipient in accordance with all applicable individual Transplant Center criteria
排除标准
- •Unwilling or unable to give informed consent, or unable to comply with the protocol including required follow-up and testing
- •Prior treatment with any rhuFlt3L product
- •Any vaccination within 4 weeks prior to CDX-301 dosing
- •Donation of blood within 8 weeks, or donation of plasma within 2 weeks prior to CDX-301 dosing
- •Any experimental treatment within 4 weeks prior to CDX-301 dosing
- •Use of systemic immunosuppressive agents (excluding topical steroids) within 12 months prior to CDX-301 dosing.
- •History of first degree relatives with primary or secondary immunodeficiency to include type 1 diabetes, multiple sclerosis, rheumatoid arthritis, scleroderma or psoriasis
- •History of tuberculosis infection
- •Herpes zoster within 3 months prior to starting study drug
- •Pregnant or nursing
- •Unwilling or unable to give informed consent, or unable to comply with the protocol including required follow-up and testing
- •Prior allogeneic transplant
- •More than one prior autologous transplant
- •Prior treatment with any rhuFlt3L product
- •Any vaccination within 4 weeks prior to transplant
- •Uncontrolled infection at the time of the transplant conditioning regimen
- •Pregnant or nursing
- •Any condition, which, in the opinion of the clinical investigator, would interfere with the evaluation of the study outcome
研究组 & 干预措施
CDX-301
Experimental
干预措施: CDX-301 (Drug)
CDX-301 and plerixafor
Experimental
干预措施: CDX-301 and plerixafor (Drug)
结局指标
主要结局
Safety and tolerability profile of CDX-301 with or without plerixafor in healthy adult sibling stem cell donors.
时间窗: 1 Year
Safety and tolerability will be evaluated by comparing the treatment regimens in regards to vital sign measurements, physical examinations and adverse event reporting.
次要结局
- The proportion of donors whose stem cells can be successfully mobilized and collected with a sufficient CD34+ cell count using CDX-301 with or without plerixafor as the mobilizing agent.(Day 6 - Day 12)
- Describe the cellular composition of allografts mobilized with CDX-301 with or without plerixafor (stem/progenitor cells, T/B/NK-cells).(Day 6 - Day 12)
- Incidence of and kinetics of neutrophil and platelet recovery after transplantation of hematopoietic cells mobilized with CDX-301 with or without plerixafor(Day 21, Day 28, Day 56, Day 100, Day 180, Day 270, Day 365.)
- Incidence of primary and secondary graft failure after transplantation of hematopoietic cells mobilized with CDX301-03 with or without plerixafor.(Day 28, Day 100, Day 180, Day 365.)
- Rate and quality of immune reconstitution as evidenced by peripheral blood immunophenotype after transplantation of hematopoietic cells mobilized with CDX-301 with or without plerixafor.(Day 28, 100, 180, 365.)
- Incidence of acute and chronic graft-versus host disease (GVHD) after transplantation of hematopoietic cells mobilized with CDX-301 with or without plerixafor.(Day 28, Day 56, Day 100, Day 180, Day 270, Day 365.)
- Incidence of CMV reactivation after transplantation of hematopoietic cells mobilized with CDX-301 with or without plerixafor in transplant recipients.(Day 28, Day 56, Day 100, Day 180, Day 270, Day 365.)
- Number of post-transplant days of hospitalization in patients that received hematopoietic cells mobilized with CDX-301 with or without plerixafor.(Day 21, 28, 56, 100, 180, 270, 365)
- Incidence of treatment-related mortality and disease relapse/progression after transplantation of hematopoietic cells mobilized with CDX-301 with or without plerixafor.(Day 21, 28, 56, 100, 180, 270, 365.)
研究者
研究点 (8)
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