NCT02189824Unknown1 期
Chemotherapy Followed by Infusion of Partially HLA Matched Unrelated Donor Cells for Patients With AML Who Are Ineligible for Stem Cell Transplantation
适应症
试验速览
- 阶段
- 1 期
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- Incidence of acute graft versus host disease within 60 days of completion of final infusion of donor lymphocytes
研究概览
简要总结
A phase 1 study of infusion of partially HLA matched unrelated donor blood or marrow cells (microtransplantation) following consolidation chemotherapy in patients with AML that are not suitable for allogenic stem cell transplantation.
详细描述
To determine the safety and tolerability of co-administration of partially HLA antigen matched unrelated donor cryopreserved donor lymphocytes (microtransplantation) with chemotherapy for patients with high risk acute myeloid leukaemia ineligible or unsuitable for high dose chemotherapy and stem cell transplantation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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
- •Newly diagnosed AML not considered suitable for allogenic stem cell transplant on the basis of age or co-morbidities
- •Complete morphological remission following 1-2 cycles of induction chemotherapy consisting of an anthracycline/cytosine arabinoside combination
- •Availability of cryopreserved donor stem cells or bone marrow with appropriate HLA matching
- •Adequate hepatic and renal function
- •Estimated life expectancy of at least 6 months
- •Patient has given informed consent or in the event of a patient not able to give informed consent, consent has been given according to hospital procedures in force at the time of trial
排除标准
- •Patient not in morphological remission following 2 cycles of induction chemotherapy
- •Use of fludarabine or other purine analogue during remission induction or use of any major immunosuppressive medication or any other immunomodulatory agent including thalidomide, lenalidomide, or azacitidine immediately prior to concurrent with administration of chemotherapy for AML or during or in the 3 months after administration of partially HLA matched 3rd party cells
- •Absence of a cryopreserved donor stem cell or bone marrow product with appropriate matching
- •Presence of significant hepatic, renal or other major organ dysfunction
- •Uncontrolled infection or bleeding prior to commencement of consolidation chemotherapy
- •Privately insured in or outpatient on the day the consent is signed and the days that cryopreserved partially HLA matched donor cells are infused
结局指标
主要结局
Incidence of acute graft versus host disease within 60 days of completion of final infusion of donor lymphocytes
时间窗: 60 days
次要结局
- Duration of complete remission(12 months)
- Duration of post chemotherapy cytopenias(60 days)
- Remission rate(12 months)
研究者
研究点 (2)
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