NCT01646645已完成2 期
A Phase II Trial of Primary Transplant Donor Derived CMVpp65 Specific T-cells for The Treatment of CMV Infection or Persistent CMV Viremia After Allogeneic Hematopoietic Stem Cell Transplantation
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 58
- 试验地点
- 1
- 主要终点
- Number of Participants With a Complete Response
研究概览
简要总结
The purpose of this study is to see how well transfusions of T-cells work in treating CMV. T-cells are a type of white blood cell that helps protect the body from infection. A transfusion is the process by which blood from one person is transferred to the blood of another. In this case, the T-cells are made from the blood of donors who are immune to CMV. The T-cells are then grown and taught to attack the CMV virus in a lab.
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
- 否
入选标准
- •Each patient must satisfy at least one of the following criteria:
- •The patient must have a clinically documented condition associated with CMV (e.g. interstitial pneumonia, hepatitis, retinitis, colitis) Or
- •The patient must have microbiological evidence of CMV viremia or tissue invasion as attested by viral culture, or detection of levels of CMV DNA in the blood or body fluids consistent with CMV infection.
- •Patient must also satisfy at least one of the following criteria:
- •The patient's CMV infection is clinically progressing or CMV viremia is persistent or increasing (as evidenced by quantitation of CMV DNA in the blood) despite two weeks induction therapy with antiviral drugs.
- •The patient has developed CMV viremia as attested by viral culture, or detection of levels of CMV DNA in blood or body fluids while receiving prophylactic doses of antiviral drugs to prevent CMV infection post transplant.
- •Or c. The patient is unable to sustain treatment with antiviral drugs due to drug associated toxicities (e.g. myelosuppression [ANC< 1000μl/ml without GCSF support] or nephrotoxicity [corrected creatinine clearance ≤ 60 ml/min/1.73 m2 or serum creatinine > 2 mg/dl]) Patient has CMV specific T-cells from the donor of his/her HSCT available. CMV infections are life threatening, and may involve multiple organ systems such as the lungs, liver, gastrointestinal tract, hematopoietic and central nervous systems. Antiviral drugs used for treatment may also compromise renal and hematopoietic function. Therefore, dysfunctions of these organs will not affect eligibility for this protocol Patients must meet the following clinical criteria to receive CMVpp65-CTL infusions
- •Stable blood pressure and circulation, not requiring pressor support
- •Evidence of adequate cardiac function as demonstrated by EKG and/or echocardiography.
- •A life expectancy of at least 3 weeks, even if requiring artificial ventilation.
- •There are no age restrictions
排除标准
- •Patients requiring high doses of glucocorticosteroids (≥ 0.3 mg/kg prednisone or its equivalent)
- •Patients who are moribund
- •Patients with other conditions not related to CMV infection (e.g. uncontrolled bacterial sepsis or invasive fungal infection) which are also life-threatening and which would preclude evaluation of the effects of a T-cell infusion.
- •Patients who are pregnant 6.1.3 Donor Inclusion Criteria 6.1.3a Donors in Group 1 (Historical Donors) Donors in Group 1 (Section 5.1) would have already been determined to be eligible and will have donated blood or leukocytes to establish CMV-specific T-cells under IRB # 05-065, 07-055, 95-024, or 11-
- •There are no additional eligibility requirements for these donors.
- •6.1.3b Donors in Groups 2 & 3 (Prospective and Volunteer Donors)
- •Transplant donors and healthy HLA typed volunteers who agree to provide T-cells for Third-party donation (section 5.1, Groups 2 and 3) will need to meet the following eligibility requirements prior to donation:
- •Donors must satisfy the criteria specified in FDA 21 CFR
- •Donors must be typed for HLA-A, B, C and DR
- •Donors must have a hemoglobin value > 10g/dl
- •Donors must be capable of undergoing, at least, a single standard 2 blood volume leukapheresis or a donation of one unit of whole blood
- •6.1.4 Donor Exclusion Criteria
- •HTLV/HIV(+) or Hepatitis B or C antigen(+) donors
- •Donors who are known CMV seronegative
结局指标
主要结局
Number of Participants With a Complete Response
时间窗: 3 years
The endpoint of this study is complete response, defined as the clearance of the CMV infection 3-7 weeks following completion of the last cycle of CMV CTLs. The evaluation of treatment efficacy will be assessed separately for patients receiving CMV specific T cells from their transplant donor.
Number of Participants With Toxicities
时间窗: 3 years
For the evaluation of toxicities, the NCI Standard Toxicity Scale 4.0 will be employed.
次要结局
未报告次要终点
研究者
研究点 (1)
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