NCT00718250Unknown1 期
A Phase I Study of Lentivirus Transduced Acute Myeloid Leukaemic Cells (AML) Expressing B7.1 (CD80) and IL-2 for the Potential Enhancement of Graft Versus Leukaemia(GvL) Effect in Poor Prognosis AML
King's College Hospital NHS Trust2 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2008年5月1日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- Toxicity and safety of the 'AML Cell Vaccine'
研究概览
简要总结
The purpose of this study is to assess the safety and tolerability of an 'AML Cell Vaccine' in patients with poor prognosis acute myeloid leukaemia (AML).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Factorial
- 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
- •Diagnosis of AML defined according to the WHO classification
- •Age ≥ 18 years
- •New presentation or relapsed AML
- •Patients must be able to give written informed consent
- •Failure to enter complete morphological remission (>5% bone marrow AML cells) or persistence of cytogenetic abnormality following intensive combination chemotherapy At day+100 post-transplant
- •HIV negative
- •No continuing use of immunosuppressive drugs
- •Absence of active systemic fungal or viral infection including HTLV-1, hepatitis B or C.
- •Adequate renal and liver function confirmed by: creatinine clearance >30mls/min; bilirubin <3.0 x upper limit of normal; AST <3.0 x upper limit of normal; prothrombin time <2.0 x upper limit of normal.
- •Performance status of 1 or less by ECOG criteria or >80% by the Karnovsky score
- •Patient must provide written informed consent and be willing to comply for the duration of the study.
- •Life expectancy >36 weeks
- •Women of childbearing potential (WCBP) must have a negative serum or urine pregnancy test within 10 - 14 days and again within 24 hours of starting the study. In addition, sexually active WCBP must agree continued abstinence from heterosexual intercourse or to use adequate contraceptive methods starting 4 weeks prior to the initiation of therapy (see appendix G for pregnancy testing and birth control guidelines while on study). WCBP must agree to have pregnancy tests every 3 weeks while on study drug (every 14 days for women with irregular cycles) and 4 weeks after the last dose of study drug. Men must also agree to use a condom if their partner is of child bearing potential, even if they have had a successful vasectomy.
排除标准
- •Age < 18 years
- •Patients not fit for intensive chemotherapy
- •Complete morphological and cytogenetic remission following intensive combination chemotherapy
- •Absence of HLA compatible donor
- •HIV positive
- •Evidence of graft versus host disease at day+100 post transplant
- •Evidence of relapse of leukaemia (≥5% bone marrow blasts)
- •Concurrent use of other forms of anti-leukaemic therapy
- •Other malignancy with the exception of carcinoma in situ.
- •Significant history of heart disease (unstable angina, myocardial within the past six months, congestive cardiac failure requiring daily treatment)
- •Evidence of active lung disease determined by chest x-ray and absence of chronic lung disease (FEV1<60% predicted, Vital capacity <60%, Tlco<50%)
结局指标
主要结局
Toxicity and safety of the 'AML Cell Vaccine'
时间窗: one year
次要结局
- relapse, leukaemia free survival and overall survival(one year)
研究者
研究点 (2)
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