Immunotherapy With Ex Vivo-Expanded Cord Blood-Derived NK Cells Combined With Rituximab High-Dose Chemotherapy and Autologous Stem Cell Transplant for B-Cell Non-Hodgkin's Lymphoma
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 22
- 试验地点
- 1
- 主要终点
- Treatment-related Mortality Within 30 Days (TRM30)
研究概览
简要总结
This phase II trial studies the side effects of cord blood-derived expanded allogeneic natural killer cells (umbilical cord blood natural killer [NK] cells), rituximab, high-dose chemotherapy, and stem cell transplant in treating patients with B-cell non-Hodgkin's lymphoma that has come back (recurrent) or that does not respond to treatment (refractory). Immune system cells, such as cord blood-derived expanded allogeneic natural killer cells, are made by the body to attack foreign or cancerous cells. Immunotherapy with rituximab, may induce changes in body's immune system and may interfere with the ability of tumor cells to grow and spread. Drugs used in chemotherapy, such as carmustine, cytarabine, etoposide, lenalidomide, melphalan, and rituximab, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. A stem cell transplant using stem cells from the patient or a donor may be able to replace blood-forming cells that were destroyed by chemotherapy used to kill cancer cells. The donated stem cells may also replace the patient's immune cells and help destroy any remaining cancer cells. Giving cord blood-derived expanded allogeneic natural killer cells, rituximab, high-dose chemotherapy, and stem cell transplant may work better in treating patients with recurrent or refractory B-cell non-Hodgkin's lymphoma.
详细描述
PRIMARY OBJECTIVE:
I. To establish the safety of this treatment by determining its treatment-related mortality (TRM) within 30 days.
SECONDARY OBJECTIVES:
I. To estimate the relapse-free survival (RFS). II. To estimate the overall survival (OS). III. To quantify duration of infused allogeneic umbilical cord blood (UCB)-derived natural killer (NK) cells in the recipient.
OUTLINE:
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 15 Years 至 70 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with B-cell lymphoma who are candidates to autologous stem-cell transplantation:
- •Primary refractory or relapsed diffuse large B-cell lymphoma in response to salvage treatment
- •Primary refractory or relapsed follicular lymphoma or other indolent B-cell histology in response to salvage treatment
- •Chemosensitive mantle-cell lymphoma in first or later line of treatment
- •Estimated serum creatinine clearance >= 60 ml/min and a normal serum creatinine for age
- •Serum glutamic-oxaloacetic transaminase (SGOT) and/or serum glutamate pyruvate transaminase (SGPT) =< 3 x upper limit of normal (ULN)
- •Total bilirubin and alkaline phosphatase (ALP) =< 2 x ULN or =< 3 x ULN for Gilbert's disease
- •Forced expiratory volume in one second (FEV1), forced vital capacity (FVC) and diffusion lung capacity (DLCO) (corrected for hemoglobin [Hgb]) >= 50% of the predicted value
- •Left ventricular ejection fraction >= 40%. No uncontrolled arrhythmias or symptomatic cardiac disease
- •Performance status < 2 (Eastern Cooperative Oncology Group [ECOG])
- •Negative beta human chorionic gonadotropin (HCG) in woman with child-bearing potential
排除标准
- •Primary central nervous system (CNS) lymphoma
- •Grade >= 3 non-hematologic toxicity from prior therapy that has not resolved to =< grade (G) 1
- •Prior whole brain irradiation
- •Active hepatitis B, either active carrier (hepatitis B surface antigen positive [HBsAg +]) or viremic (hepatitis B virus [HBV] deoxyribonucleic acid [DNA] >= 10,000 copies/mL, or >= 2,000 IU/mL)
- •Evidence of either cirrhosis or stage 3-4 liver fibrosis in patients with chronic hepatitis C or positive hepatitis C serology
- •Active infection requiring parenteral antibiotics
- •Human immunodeficiency virus (HIV) infection
- •Radiation therapy in the month prior to enroll
- •Breastfeeding females
研究组 & 干预措施
Treatment (chemotherapy, NK infusion, stem cell transplant)
See Detailed Description.
干预措施: Autologous Hematopoietic Stem Cell Transplantation (Procedure)
Treatment (chemotherapy, NK infusion, stem cell transplant)
See Detailed Description.
干预措施: Carmustine (Drug)
Treatment (chemotherapy, NK infusion, stem cell transplant)
See Detailed Description.
干预措施: Cord Blood-derived Expanded Allogeneic Natural Killer Cells (Biological)
Treatment (chemotherapy, NK infusion, stem cell transplant)
See Detailed Description.
干预措施: Cytarabine (Drug)
Treatment (chemotherapy, NK infusion, stem cell transplant)
See Detailed Description.
干预措施: Etoposide (Drug)
Treatment (chemotherapy, NK infusion, stem cell transplant)
See Detailed Description.
干预措施: Filgrastim (Biological)
Treatment (chemotherapy, NK infusion, stem cell transplant)
See Detailed Description.
干预措施: Lenalidomide (Drug)
Treatment (chemotherapy, NK infusion, stem cell transplant)
See Detailed Description.
干预措施: Melphalan (Drug)
Treatment (chemotherapy, NK infusion, stem cell transplant)
See Detailed Description.
干预措施: Rituximab (Biological)
结局指标
主要结局
Treatment-related Mortality Within 30 Days (TRM30)
时间窗: Up to 30 days
Participants that had Treatment-related mortality within 30 days.
次要结局
- Number of Participants Who Survived(From the time of transplant, assessed up to day 180)