NCT00935597Unknown1 期
A Phase I Trial of Host Dendritic Cell Infusion After Allogeneic Stem Cell Transplant for Prevention or for Treatment of Relapsed Disease in Patients With Advanced Hematologic Malignancies
适应症
试验速览
- 阶段
- 1 期
- 入组人数
- 25
- 试验地点
- 2
- 主要终点
- The incidence of severe graft versus host disease (GVHD) grade C or D as defined by IBMTR grading.
研究概览
简要总结
The purpose of this study is to assess preliminary efficacy and to determine the safety and feasibility of ex vivo generated dendritic cell (HDC) infusion with and without donor lymphocyte infusion (DLI) after allogeneic stem cell transplant (SCT). We also wish to establish the feasibility of apheresis shipment as well as vaccine shipment and stability in the population.
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
- •Age 18-70
- •Ability to sign informed consent
- •ECOG performance status ≤3
- •Life expectancy > 6 months
- •Adequate cardiac function: MUGA or Echocardiogram demonstrating >50% Ejection Fraction
- •Adequate pulmonary function with DLCO > 50%
- •Adequate hepatic function
- •Bilirubin ≤ 1.5mg/dl
- •Alkaline phosphatase ≤5 times the upper limit of normal
- •Aspartate aminotransferase (AST) or serum glutamic-oxaloacetic transferase (SGOT) ≤ 3 times the upper limit of normal
- •Alanine aminotransferase (ALT) or serum glutamic pyruvic transaminase (SGPT) ≤ 3 times the upper limit of normal
- •Adequate renal function Estimated creatinine clearance > 40ml/min
- •Diagnosis of one of the following
- •Non-Hodgkin's lymphoma excluding Follicular lymphoma and Marginal Zone Lymphoma
- •Hodgkin's lymphoma
- •Multiple myeloma
- •Chronic lymphocytic leukemia
- •Eligible for allogeneic stem cell transplant with identified HLA-identical sibling (6/6 HLA match) or volunteer unrelated donor (8/8 allele HLA-matched (A, B, Cw, DRB1)
- •Women of childbearing potential must have a negative serum pregnancy test prior to enrollment
- •Women of childbearing potential must use effective means of birth control throughout the study.
- •Men should not father a child while enrolled in the study. Effective means of birth control include condom, vasectomy or abstinence.
排除标准
- •Malignancies other than melanoma within five years of study entry, except carcinoma in-situ of the cervix or basal/squamous cell skin cancers
- •Concurrent illnesses that would preclude survival > 6 months other than the disease under study
- •Pregnancy or nursing
- •HIV infection
- •Treatment with prior donor lymphocyte infusion
- •Prior allogeneic stem cell transplant
- •History of autoimmune diseases including systemic lupus erythematosus, rheumatoid arthritis and thyroiditis
- •Active infections including fungal infections and viral hepatitis
- •GVHD greater than grade I GVHD of the skin
- •Patient Exclusion Criteria for Part B (post Stem Cell Transplant)
- •Malignancies other than melanoma within five years of study entry, except carcinoma in-situ of the cervix or basal/squamous cell skin cancers
- •Concurrent illnesses that would preclude survival > 6 months other than the disease under study.
- •Pregnancy or nursing
- •HIV infection
- •Treatment with prior donor lymphocyte infusion
- •Prior allogeneic stem cell transplant
- •More than 4 prior relapses
- •History of autoimmune diseases including systemic lupus erythematosus, rheumatoid arthritis and thyroiditis
- •Active infections including fungal infections and viral hepatitis
- •GVHD greater than grade I GVHD of the skin
- •No cytotoxics will be given within 4 weeks of administration of the investigational cell therapy
- •Patients cannot receive any investigational agents within 30 days prior to administration of the investigational cell therapy
结局指标
主要结局
The incidence of severe graft versus host disease (GVHD) grade C or D as defined by IBMTR grading.
时间窗: 2 weeks following each HDC infusion and 4, 6 and 8 weeks after the last HDC infusion
次要结局
- The incidence of grade A and B acute GVHD, limited chronic GVHD, infusion reactions, graft loss and donor chimerism(2 weeks following each HDC infusion and 4, 6 and 8 weeks after the last HDC infusion)
研究者
研究点 (2)
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