NCT01696461已完成2 期
A Phase II Study Evaluating the Safety and Efficacy of Subcutaneous Plerixafor for the Mobilization and Transplantation of HLA-Matched Sibling Donor Hematopoietic Stem Cells in Recipients With Hematological Malignancies
Center for International Blood and Marrow Transplant Research12 个研究点 分布在 1 个国家目标入组 127 人开始时间: 2013年5月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 127
- 试验地点
- 12
- 主要终点
- Percentage of Donors Whose Cells Were Successfully Mobilized and Collected With a Sufficient CD34+ Cell Dose Using Plerixafor as the Mobilizing Agent, Using an Intention-to-treat Analysis.
研究概览
简要总结
This is a Phase II, open-label, two strata, multicenter, prospective study of plerixafor-mobilized HLA-identical sibling allografts in recipients with hematological malignancies. This study will establish the safety and efficacy of subcutaneous plerixafor for this purpose.
详细描述
The primary objective is to determine the proportion of donors whose cells can be successfully mobilized and collected with a sufficient CD34+ cell dose using plerixafor as the mobilizing agent, using an intention-to-treat analysis. Donor mobilization following plerixafor will be considered successful if ≥ 2.0x10e6 CD34+ cells/kg recipient weight are collected in no more than two leukapheresis collections.
All donors receiving plerixafor will be included in the analysis of the primary objective based on the intention-to-treat principle.Recipients will be classified into one of the two strata, myeloablative or reduced intensity, according to his/her conditioning regimen. The target enrollment is 64 donor/recipient pairs, 32 pairs per stratum.
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 eligibility will be determined according to applicable federal, state and local regulations and institutional standards
- •18-65 years of age
- •6/6 HLA-matched sibling
- •Fulfill individual Transplant Center criteria to serve as a mobilized blood cell donor
- •Serum creatinine <2.0mg/dl
- •18 to 65 years of age
- •6/6 HLA antigen matched sibling willing to donate PBSC for transplant
- •Fulfill individual Transplant Center Criteria for transplant
- •One of the following diagnoses:
- •Acute myelogenous leukemia (AML) in 1st remission or beyond with <5% marrow blasts and no circulating blasts. Marrow must be done within 30 days of the start of transplant conditioning regimen in alignment with other pre-transplant assessments.
- •Acute lymphoblastic leukemia (ALL) in 1st remission or beyond with <5% marrow blasts and no circulating blasts
- •Myelodysplastic syndrome, either intermediate-1,2, or high risk by International Prognostic Scoring System or transfusion dependent
- •Chronic myelogenous leukemia (CML) failing or intolerant to tyrosine kinase inhibitor based therapy
- •Non-Hodgkin's lymphoma (NHL) or Hodgkin's disease (HD) in 2nd or greater complete remission, partial remission, or in relapse (but with at least stable disease after most recent therapy)
- •Chronic lymphocytic leukemia (CLL), relapsing after at least one prior regimen, or in remission with 17p deletion
- •Serum creatinine must be <2.0mg/dl
- •Total bilirubin and aspartate aminotransferase (AST) <3x normal
- •Infectious disease marker (IDM) monitoring will be performed per institutional standards
- •Karnofsky performance status of 70% or greater.
- •Patients who have undergone a prior autologous transplantation are eligible for a reduced intensity transplant only
排除标准
- •Donor unwilling or unable to give informed consent, or unable to comply with the protocol including required follow-up and testing
- •Donor already enrolled on another investigational agent study
- •Pregnant or breast feeding females, or females not willing or able to use adequate contraception if sexually active
- •Patient unwilling or unable to give informed consent, or unable to comply with the protocol including required follow-up and testing
- •Patients with active, uncontrolled infection at the time of the transplant preparative regimen
- •Pregnant or breast feeding females, or females not willing or able to use adequate contraception if sexually active
- •Patients with a history of previous central nervous system (CNS) tumor involvement showing active symptoms or signs along with documented disease on lumbar puncture and MRI of the brain within 30 days of start of conditioning
- •A condition, which, in the opinion of the clinical investigator, would interfere with the evaluation of primary and secondary endpoints.
研究组 & 干预措施
Related donors receiving plerixafor
Experimental
Collection of sufficient CD34+ cells using plerixafor as the mobilizing agent.
Eligible donors determined according to institutional standards
- 18-65 years of age
- 6/6 HLA-matched sibling
- Fulfill individual Transplant Center criteria to serve as a mobilized blood cell donor
- Serum creatinine <1.5 x institution upper limit of normal (ULN) or estimated creatinine clearance (CLCR) >50 mL/min
Treatment Description:
- Receive subcutaneous plerixafor at 240 μg/kg and commence leukapheresis approximately 4 hours later.
- Leukapheresis will be performed up to two consecutive days. The target CD34+ cell dose is > 4.0 x 106/kg with a minimum of > 2.0 x 106/kg.
干预措施: Plerixafor (Drug)
结局指标
主要结局
Percentage of Donors Whose Cells Were Successfully Mobilized and Collected With a Sufficient CD34+ Cell Dose Using Plerixafor as the Mobilizing Agent, Using an Intention-to-treat Analysis.
时间窗: donation
Donor mobilization following plerixafor was considered successful if ≥ 2.0x106 CD34+ cells/kg recipient weight was collected in no more than two leukapheresis collections.
次要结局
- Incidence and Severity of Acute Toxicities(baseline, Day 1, Day 2, Day 3)
- Adverse Effects(30 minutes, 60 minutes, 120 minutes, 240 minutes, 1 month, 6 months, 12 months post donation for each subject)
- Incidence of and Kinetics of Neutrophil and Platelet Recovery After Transplantation of Hematopoietic Cells Mobilized With Plerixafor(Day +1 through neutrophil recovery or Day 21 (whichever is first))
- T-cell (CD3+) and Myeloid (CD33+) Chimerism After Transplantation of Hematopoietic Cells Mobilized With Plerixafor(Chimerism was evaluated at serial timepoints post HCT in patients in both RIC and MAC strata. Chimerism was assessed at Day +28, +100, +180, and +365)
- Primary Graft Failure After Transplantation of Hematopoietic Cells Mobilized With Plerixafor(Day 28)
- Incidence of Acute Graft-versus-host Disease (GVHD)(Day 100)
- Immune Reconstitution(Day 28, 100, 180, 365)
- Incidence of Cytomegalovirus (CMV) Reactivation After Transplantation With Cells Mobilized With Plerixafor.(day 365)
- Treatment-related Mortality and Disease Relapse/Progression(Day 180, 365)
- Progression-free and Overall Survival(Day 180, 365)
- Cellular Composition of Allografts(donation)
- Incidence of Chronic Graft-versus-host Disease (GVHD)(Day 365)
- Secondary Graft Failure After Transplantation of Hematopoietic Cells Mobilized With Plerixafor(Day 365)
- CD34+ Cell Count of Allografts(donation)
研究者
研究点 (12)
Loading locations...
相似试验
尚未招募
2 期
Phase II Clinical Study to Evaluate the Efficacy and Safety of HLX07+HLX10 +mFOLFOX6 or HLX07 Monotherapy in Patients With mCRCCRCNCT05239650Shanghai Henlius Biotech50
招募中
2 期
A Clinical Study of 9MW2821 (and PD-1 Inhibitor) in Locally Advanced or Metastatic Triple-Negative Breast CancerTriple-Negative Breast CancerNCT06492005Mabwell (Shanghai) Bioscience Co., Ltd.160
已完成
2 期
Subcutaneous Alemtuzumab (CAMPATH®, MabCampath®) in Relapsed/Refractory B-Cell Chronic Lymphocytic LeukemiaB-Cell Chronic Lymphocytic Leukemia (B-CLL)NCT00328198Genzyme, a Sanofi Company86
进行中（未招募）
2 期
A Study of SI-B001+SI-B003 Combined With Platinum-based Chemotherapy as First-line Treatment in Patients With Recurrent or Metastatic Head and Neck Squamous Cell CarcinomaNCT06668961Sichuan Baili Pharmaceutical Co., Ltd.48
招募中
2 期
A Study of BL-B01D1 in Patients With Recurrent GlioblastomaRecurrent GlioblastomaNCT06598787Sichuan Baili Pharmaceutical Co., Ltd.20