The Pre-Emptive Use of Recipient-Derived Autologous Cytomegalovirus (CMV)-Specific Cytotoxic T Cells for Cytomegalovirus (CMV) Reactivation After Allogeneic Stem Cell Transplantation
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 6
- 试验地点
- 2
- 主要终点
- Success Rate of Cytotoxic T Cells
研究概览
简要总结
The goal of this clinical research study is to learn if giving cytotoxic T lymphocytes (CTLs) can help control CMV when it reactivates (becomes active again) in patients who receive an allogeneic stem cell transplant. Researchers also want to learn about the safety of giving CTLs to patients who have had a stem cell transplant.
详细描述
The CTLs:
Blood (about 34 tablespoons) will be drawn 1 time. The blood will be frozen and stored in a laboratory at MD Anderson for future use to make the CTLs. If CMV comes back after your transplant, the blood will be used to create CTLs. To create CTLs, blood cells are grown in the laboratory and trained to kill CMV. If the blood is not used to make the CTLs within 3 years, it will be destroyed.
CTL Administration:
If your CMV becomes active after your stem cell transplant, you will receive the CTLs through a needle in your vein over 1-5 minutes one time, within 72 hours after CMV becomes active again. Before you receive the CTLs, you will receive Benadryl (diphenhydramine) and Tylenol (acetaminophen) by mouth to help reduce the risk of side effects. This can be done in either the hospital (if not yet discharged after your transplant) or in the outpatient clinic (if you are discharged).
Your vital signs will be monitored at the end of the infusion, and then at 30 and 60 minutes after the infusion. Your oxygen level will be measured by pulse oximetry. For this test, a clothespin-shaped clip will be placed on your finger for at least 30 minutes. If you are an outpatient, you will remain in the clinic for at least 1 hour after the CTL infusion.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •STEP 1: Within 30 days of study entry: Patients with a history of bone marrow disorders including hematological malignancies and aplastic anemia, Myelodysplastic Syndrome (MDS) and Myeloproliferative disorder (MPD) planning to undergo allogeneic HSCT with reduced intensity or myeloablative conditioning regimens.
- •Disease status must be complete remission by standard criteria for Lymphoma and Acute Leukemia patients.
- •Patients with Myelodysplastic Syndrome (MDS) and Myeloproliferative Disorder (MPD) must have <5% blasts in the bone marrow.
- •Patients with T Cell ALL must be in complete remission and MRD negative (-) by flow cytometry and molecular studies.
- •Patients >/= 18 years of age.
- •Karnofsky greater than or equal to 80%.
- •CMV seropositive.
- •Donor is either matched related, matched unrelated, mismatched unrelated, or haploidentical. Cord blood recipients are also eligible.
- •Hgb greater than 10 g/L.
- •Patient or patient's legal representative, parent(s) or guardian able to provide written informed consent.
- •Negative pregnancy test in female patients of childbearing potential.
- •STEP 2: Eligibility at time of generating and infusing CMV-specific cytotoxic T cells (adoptive immunotherapy): CMV reactivation defined as CMV DNAemia >/= 137 copies/ml.
- •Evidence of neutrophil engraftment defined as the absolute neutrophil count (ANC)> 0.5 X 10^3/for 3 consecutive days.
- •Clinical status to allow tapering of steroids to less than 0.5 mg/kg/day prednisone or equivalent.
- •Negative pregnancy test in female patients of childbearing potential.
排除标准
- •STEP 1: Within 30 days of study entry: T cell leukemia or lymphoma.
- •CMV seronegative.
- •Positive for HIV, HBV, HCV, HTLV1 and/or HTLV
- •STEP 2: Eligibility at time of generating and infusing CMV-specific cytotoxic T cells (adoptive immunotherapy): Documented CMV end-organ disease.
- •Patients receiving ATG, or Campath within 28 days of CMV reactivation.
- •Patients with other uncontrolled infections. For bacterial infections, patients must be receiving definitive therapy and have no signs of progressing infection for 72 hours prior to generating CTLs. For fungal infections patients must be receiving definitive systemic anti-fungal therapy and have no signs of progressing infection for 1 week prior to generating CTLs. Progressing infection is defined as hemodynamic instability attributable to sepsis or new symptoms, worsening physical signs or radiographic findings attributable to infection. Persisting fever without other signs or symptoms will not be interpreted as progressing infection.
- •Patients who have received donor lymphocyte infusion (DLI) within 28 days.
- •Patients with active acute GVHD grades II-IV.
- •Active and uncontrolled relapse of malignancy.
结局指标
主要结局
Success Rate of Cytotoxic T Cells
时间窗: 28 days
Treatment considered a success if the patient does not require initiation of cytomegalovirus (CMV) anti-viral therapy.
Number of Participants With Non-Relapse Mortality
时间窗: 6 months
Non-relapse mortality defined as death because of causes other than relapse of the underlying hematological malignancy.
次要结局
未报告次要终点