临床试验/NCT02493829

NCT02493829Unknown1 期

A Phase I Study of B7.1 (CD80)/IL-2 Immune Gene Therapy for High Risk MDS RAEB-2 and Acute Myeloid Leukaemia Patients Unsuitable for Allogeneic Haematological Stem Cell Transplant

King's College London0 个研究点目标入组 10 人开始时间: 2017年5月最近更新: 2017年4月13日

适应症

试验速览

阶段: 1 期
发起方: King's College London
入组人数: 10
主要终点: Vaccine-related toxicity based on the NCI criteria V4.0

研究概览研究设计入排标准结局指标研究者记录与标识符相似试验

研究概览

简要总结

The study will be an open label, single arm, phase I study intended to identify the safety and tolerability of "AML Cell Vaccine" given to eligible MDS RAEB-2 and AML patients who have achieved a best response of complete remission or partial remission following their first or second course of standard induction chemotherapy.

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

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 MDS RAEB-2 or primary (de novo) or secondary AML defined according to the WHO classification either as a new diagnosis or as a relapse.
•Patients for whom the optimal therapy in CR1 would be to undergo allogeneic bone marrow transplantation, but for whom this procedure is either not recommended (e.g. due to comorbidities) or not available (e.g. lack of a suitable donor).

排除标准

•Patients with MDS RAEB-2 or AML and favourable prognostic profile (good risk cytogenetics: t(15;17)(q22;q12~21), inv16(p13q22)/t(16;16)(p13;q22), t(8;21)(q22;q22) or cytogenetically normal AML with NPM1 mutation and absence of Flt-3 ITD).
•Patients unsuitable for standard induction chemotherapy.
•Patients who have previously undergone or will be able to undergo allogeneic transplantation.
•Patients who have had previous or current treatment with any form of investigational immunotherapy.

结局指标

主要结局

Vaccine-related toxicity based on the NCI criteria V4.0

时间窗: 52 weeks

Frequency, severity of adverse events to the AML cell vaccine

时间窗: 52 weeks

次要结局

未报告次要终点

研究者

发起方

King's College London

申办方类型

Other

责任方

Sponsor

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