Institutional Protocol of Bone Marrow Transplantation Using CD34-Selected Peripheral Blood Stem Cells From Related Haploidentical or Unrelated Donors for Treatment of Malignant and Nonmalignant Disorders
试验速览
- 阶段
- 不适用
- 状态
- Available
- 试验地点
- 1
研究概览
简要总结
This expanded access protocol studies bone marrow transplantation using CD34-selected stem cells from related or unrelated donors in treating participants with cancer or other disorders. Stem cells collected from the donor will be processed using a new device called CliniMACS CD34 Reagent System which marks the blood cells collected from the donor with a special protein called "antibody" that tags only the donor stem cells, sorting out other cells of the blood and immune system. This is done to remove, at least partially, some of the T cells. T cells are the cells in the blood that work as scavengers of the immune system deciding what belongs and what does not. These cells can sometimes cause rejection of the donor graft or a condition called graft-versus host disease (GVHD), where the donor cells can attack the body of the recipient. A bone marrow transplantation using CD34-selected stem cells may reduce the risk of these unwanted side effects of transplant as much as possible.
详细描述
PRIMARY OBJECTIVES:
I. To provide a source of CD34-selected stem cells for patients with malignant and nonmalignant disorders undergoing bone marrow transplantation from haploidentical (human leukocyte antigen [HLA]-mismatched) related donors or HLA-compatible unrelated donors
SECONDARY OBJECTIVES:
I. Monitoring the safety of the CD34-selected stem cells for the recipient, as measured by adverse events related to stem cell infusion, incidence of engraftment of neutrophils and platelets, incidence of acute and chronic GVHD, and one year overall survival, disease-free survival, and primary disease recurrence.
OUTLINE:
研究设计
- 研究类型
- Expanded Access
入排标准
- 年龄范围
- — 至 70 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with malignant or nonmalignant diseases that can benefit from alternative stem cell transplantation according to institutional standard practice guidelines
- •Patients lacking a healthy human leukocyte antigen (HLA)-identical related donor and having one of the following alternative donor sources:
- •HLA-haploidentical related (HLA antigen genotypic match >= 4/8 and <= 7/8) or
- •Unrelated donor that is HLA matched at >= 7/8 HLA antigen loci
- •The selected donor must also be:
- •Able to receive granulocyte colony-stimulating factor (G-CSF, filgrastim) and undergo apheresis either through placement of peripheral or temporary central venous catheter, based on institutional guidelines for peripheral blood stem cell collection
- •Meet all institutional standard criteria for clearance for peripheral stem cell collection
- •Recipients must meet institutional treatment standards based on pre-transplant evaluations including:
- •Adequate major organ functions
- •Free of major systemic infections
- •Not pregnant, if female of childbearing age (post-pubertal)
- •Recipient (if >= 18 years) or their parent/legal guardian (if < 18 years) must be able to sign the informed consent form for the treatment plan; assent will be obtained from recipients 7-17 years of age, in accordance to our institutional guidelines
排除标准
- •Patients not meeting clearance criteria for bone marrow transplantation (BMT) based on standard institutional guidelines
- •Presence of anti-HLA antibodies against donor antigens in a recipient or anti-HLA antibodies against recipient antigens in a donor
- •Known allergy to murine (mouse) protein or iron-dextran
研究者
Eneida Nemecek
Principal Investigator
OHSU Knight Cancer Institute