NCT00241358已完成1 期
A Phase I/II Study Evaluating the Safety and Efficacy of AMD3100 for the Mobilization and Transplantation of HLA-Matched Sibling Donor Hematopoietic Stem Cells in Patients With Advanced Hematological Malignancies
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 92
- 试验地点
- 1
- 主要终点
- Proportion of Recipients Who Successfully Engraft by Day +21 After Transplant (Recipient Only)
研究概览
简要总结
The purpose of this study is to determine if peripheral blood cells collected following AMD3100 mobilization can be used safely for hematopoietic cell transplantation into HLA-matched recipients.
详细描述
This study will determine if peripheral blood cells collected following AMD3100 mobilization can be used safely for hematopoietic cell transplantation into HLA-matched recipients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Donor criteria:
- •Donor is 18 to 70 years of age inclusive
- •If female and of child-bearing age, must be:
- •non-pregnant,
- •not breast feeding and
- •using adequate contraception
- •Donor is a 6/6 HLA-matched sibling willing to donate peripheral blood stem cell for transplant
- •Donor must be willing to provide written informed consent.
- •Adequate cardiac function with no history of congestive heart failure and no history of atrial fibrillation or ventricular tachyarrhythmia.
- •Adequate renal function as defined by a serum creatinine clearance of ≥75% of normal (Cockcroft-Gault equation)
- •Adequate hepatic function as defined by a total bilirubin <2x normal or absence of hepatic fibrosis/cirrhosis
- •Adequate neurologic function as defined by:
- •No evidence of a severe central or peripheral neurologic abnormality.
- •No history of cerebrovascular accident or seizure disorder requiring anticonvulsant medication
- •Must be HIV-1 & 2 antibody, HIV-1 antigen, and HTLV-I & II antibody sero-negative, by FDA licensed test.
- •Must have an ECOG performance status of 0 or 1
- •Must demonstrate ability to be compliant with study regimen.
- •Must not have an active infection at the time of study entry
- •Not have active alcohol or substance abuse within 6 months of study entry
- •Not currently enrolled in another investigational agent study
- •Not have any medical condition, which, in the opinion of the clinical investigator, would interfere with his/her evaluation
- •Recipient criteria:
- •18 to 65 years of age inclusive
- •Willing and has a 6/6 HLA-matched sibling willing to donate PBSC for transplant
- •Provide signed informed consent
- •If female and of child-bearing age, must be:
- •non-pregnant,
- •not breast feeding, and
- •using adequate contraception
- •Patient must have one of the following diagnoses:
- •AML in 1st or subsequent remission or in relapse
- •ALL in 1st or subsequent remission or in relapse
- •MDS and intermediate 1 or 2, or high risk by the International Prognostic Scoring System
- •CML in accelerated or second chronic phase
- •NHL or HD in 2nd or greater complete remission, partial remission,or refractory relapse
- •CLL Rai Stage 2-4, failing at least 2 prior regimens
- •MM Stage 2-3
- •Adequate cardiac function with a left ventricular ejection fraction ≥ 40%
- •Adequate pulmonary function defined as:
- •No severe or symptomatic restrictive or obstructive lung disease, and
- •formal pulmonary function testing showing an forced expiratory volume at 1 second (FEV1) ≥50% of predicted and a diffusion capacity of the lung for carbon monoxide (DLCO) ≥40% of predicted, corrected for hemoglobin
- •Adequate renal function as defined by a serum creatinine clearance of ≥75% of normal (Cockcroft-Gault equation)
- •Adequate hepatic function as defined by a total bilirubin <2x normal or absence of hepatic fibrosis/cirrhosis
- •Adequate neurologic function as defined by no evidence of a severe central or peripheral neurologic abnormality. Patients with a history of previous central nervous system tumor involvement are eligible provided they are without symptoms or signs and the CNS is now free of disease on lumbar puncture and CT scan of the brain
- •No evidence of active infection at the time of the transplant preparative regimen or at the time of transplantation
- •Patient must be HIV-1 & 2 antibody, HIV-1 antigen, and HTLV-I & II antibody sero-negative, by FDA licensed test
- •ECOG performance status of 0 or 1
- •Must demonstrate ability to be compliant with medical regimen
- •Not have active alcohol or substance abuse within 6 months of study entry
- •Not be concurrently enrolled on another study involving an investigational agent
- 另有 1 项未显示
排除标准
- 未提供
研究组 & 干预措施
Subcutaneous (SC) Treatment Plan - Donor
Active Comparator
- Day 1: Mobilization with 240 mcg/kg SC AMD3100 and leukopheresis
- If PBSC collected are not adequate, then donor will again be mobilized with AMD3100 and have leukopheresis collection on day 3.
干预措施: AMD3100 (Drug)
Intravenous (IV) Treatment Plan - Donor
Experimental
- Day -3: Mobilization with 80-480 mcg/kg/day IV AMD3100 and PK analysis
- Day 1: Mobilization with 240 mcg/kg/day SC AMD3100 and leukopheresis
- If PBSC collected are not adequate, then donor will again be mobilized with AMD3100 and have leukopheresis collection on day 3.
干预措施: AMD3100 (Drug)
Recipients
Other
-
Conditioning Regimen
-
Cyclophosphamide 60mg/kg/day on Days -3 and -2
-
TBI 550cGy on Day -1
-
GVHD prophylaxis
*Cyclosporin 3.0mg/kg/day beginning on Day -1 then tapered through Day +100
- PBSC transplant on Day 0
干预措施: Stem Cell Transplant (Procedure)
结局指标
主要结局
Proportion of Recipients Who Successfully Engraft by Day +21 After Transplant (Recipient Only)
时间窗: Day +21
-Defined as neutrophil count ≥ 500/ul following conditioning regimen induced nadir
Proportion of Donors From Whom a Sufficient Number of Cells for Transplantation Are Collected in no More Than 2 LP Procedures Following Mobilization With AMD3100 (Donor Only)
时间窗: Day 1-3
-Defined as the proportion of donors collecting \>2.0x106 CD34+ cells/kg \[recipient weight\]
Proportion of Recipients Who Experience Grade 2-4 Acute GVHD (Recipient Only)
时间窗: By Day 100 after transplant
-Incidence and severity of acute GVHD (aGVHD) will be assessed based on the Seattle criteria
次要结局
- Proportion of Recipients Who Experience Mortality Before Day 100 After Transplant (Recipient Only)(100 days after transplant)
- Quality of Life During Stem Cell Mobilization (Recipients Only)(48-72 hours after last dose of AMD3100)
- Proportion of Donors Who Experience Infusional Toxicity (Donor Only)(Day +1 to +3 (SC donor arm) and Day -3 to +3 (IV donor arm))
- To Determine the Pharmacokinetics of IV AMD3100 (IV Donor Arm Only) as Measured by Mean AUC From Time 0 to Infinity(0 to 24 hours after dose of IV AMD3100)
- Proportion of Recipients Who Experience Chronic GVHD (Recipient Only)(Between Day +100 and +365 post-transplant)
- To Determine the Pharmacokinetics of IV AMD3100 (IV Donor Arm Only) as Measured by Cmax(0 to 24 hours after dose of IV AMD3100)
研究者
研究点 (1)
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