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临床试验/NCT00383994
NCT00383994已完成1 期

Immunotherapy With NK Cell, Rituximab and Rhu-GMCSF in Non-Myeloablative Allogeneic Stem Cell Transplantation

M.D. Anderson Cancer Center1 个研究点 分布在 1 个国家目标入组 6 人开始时间: 2006年9月最近更新:
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
6
试验地点
1
主要终点
Dose-limiting toxicities (DLTs) for NK cells infusions after non-myeloablative transplantation for lymphoid malignancies

研究概览

简要总结

The goal of this clinical research study is to find out if giving a boost of natural killer (NK) cells from a donor combined with Rituxan (rituximab), can help to control disease in patients who have already received an allogeneic stem cell transplant. The safety of this treatment will also be studied. Participants have recurrent chronic lymphocytic leukemia (CLL) or lymphoma after non-myeloablative stem cell transplantation.

Primary Objectives:

1.0 To determine the safety of Natural Killer (NK) cells and Rituximab + rhu-Granulocyte-macrophage colony-stimulating factor (GMCSF) in patients with persistent or recurrent B-cell lymphoid malignancies after non-myeloablative stem cell transplantation.

2.0 To determine factors associated with response.

详细描述

Rituximab is designed to attach to lymphoma cells, causing them to die. GM-CSF and NK cells may increase rituximab's ability to kill these cells.

Before you can start treatment on this study, you will have what are called "screening tests." These tests will help the doctor decide if you are eligible to take part in this study. You will have your complete medical history recorded and a physical exam. Your blood (about 2 tablespoons) will be collected for routine tests. A bone marrow aspirate will be performed. To collect a bone marrow aspirate, an area of the hip or chest bone is numbed with anesthetic and a small amount of bone marrow is withdrawn through a large needle. You will have computerized tomography (CT) scans as well as positron emission tomography (PET) or gallium scans to learn the status of your disease. Women who are able to have children must have a negative blood or urine pregnancy test.

If you are found eligible to take part in this study, you will receive treatment as an outpatient. You will receive GM-CSF 3 times a week for 4 weeks through a vein, starting the day before you receive the administration of rituximab. You will receive rituximab over 4 to 8 hours through a vein, once weekly for 4 weeks. You will also get a boost of NK cells from the same donor from whom you received your original transplant. These cells will be infused through a vein (over 30 to 60 minutes) after the 4th dose of rituximab. If you are receiving a cell infusion from somebody who you are not related to, the infusion may have to be done later if cells were not available as scheduled.

The CliniMACS System is a medical device that is used to separate types of blood cells from blood that is removed from the body during leukapheresis. These separated cells are processed for use in treatments such as stem cell transplants.

During this treatment, you will be examined as needed, and blood samples (1 tablespoon once or twice a week) will be taken for routine tests. You may need to receive blood transfusions during this study if your blood cell counts remain low.

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

性别
All
接受健康志愿者

入选标准

  • Patients with previous diagnosis of CD20+ B-cell CLL and non-Hodgkin's lymphoma who have failed standard conventional chemotherapy, and who had persistent disease at 3 months, or progressive disease after non-myeloablative allogeneic transplantation.
  • Donor willingness to donate peripheral blood (same donor of the original transplant).
  • Negative Beta HCG in a woman with child bearing potential defined as not post-menopausal for 12 months or not previous surgical sterilization.

排除标准

  • Pregnancy or lactation
  • HIV , HTLV-I or hepatitis.
  • Active infection(s) >/= grade
  • Severe active concomitant medical or psychiatric illness.
  • Concurrent active GVHD requiring tacrolimus.

研究组 & 干预措施

Immunotherapy with NK Cell, Rituximab + GM-CSF

Experimental

Immunotherapy in Non-myeloablative Allogeneic Stem Cell Transplantation

GM-CSF = Granulocyte-Macrophage Colony-Stimulating Factor

干预措施: GM-CSF (Drug)

Immunotherapy with NK Cell, Rituximab + GM-CSF

Experimental

Immunotherapy in Non-myeloablative Allogeneic Stem Cell Transplantation

GM-CSF = Granulocyte-Macrophage Colony-Stimulating Factor

干预措施: Rituximab (Drug)

Immunotherapy with NK Cell, Rituximab + GM-CSF

Experimental

Immunotherapy in Non-myeloablative Allogeneic Stem Cell Transplantation

GM-CSF = Granulocyte-Macrophage Colony-Stimulating Factor

干预措施: NK Cell Infusion (Biological)

结局指标

主要结局

Dose-limiting toxicities (DLTs) for NK cells infusions after non-myeloablative transplantation for lymphoid malignancies

时间窗: Evaluated for toxicity within 6 weeks of treatment

Maximum tolerated dose (MTD) is the highest dose with 10 patients treated and 5 or fewer patients with DLT.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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