Comprehensive Genomic Profiling and Next Generation Functional Drug Screening for Patients With Aggressive Haematological Malignancies: Next Generation Personal Hematology
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Percentage of patients with a ratio ≥1.3 of progression free survival (PFS) compared to most recent treatment
研究概览
简要总结
EXALT-2 is a prospective, randomized, three arm study for treatment decision guided either by either comprehensive genomic profiling, next generation drug screening or physician's choice
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •patient is suffering from aggressive haematological disease AND has undergone at least two lines of previous therapies AND/OR has undergone at least one previous therapy and no standard treatment is available in the specific disease setting and disease specific guidelines recommend treatment in studies.
- •duration of last response is less than 6 months defined as first day of last treatment to date of relapse, the response duration has to be available with dates (dd/mm/yyyy) for initiation of and relapse to previous treatment.
- •best response to previous treatment has to be available.
- •The patient is able to give written informed consent and wishes to undergo further therapy
- •further therapy is medically feasible
- •tumor cell-containing samples can be obtained
排除标准
- •current participation in another experimental clinical trial
- •performance status does not allow participation (ECOG ˃ 1)
- •pregnancy, tested at screening
- •patient suffers from classical or nodular, lymphocyte predominant Hodgkins lymphoma.
- •other malignoma, diagnosed <1a before inclusion (except localized squamous cell carcinoma of the skin, surgically curable melanoma of the skin, basal cell carcinoma of the skin)
结局指标
主要结局
Percentage of patients with a ratio ≥1.3 of progression free survival (PFS) compared to most recent treatment
时间窗: Through study completion, an average of 8 month
The study aims to identify if next-generation functional drug screening (ngFDS) and/or comprehensive genomic profiling (CGP; FoundationOne®Heme) compared to physicians' choice guided treatment will have an increased percentage of patients with a ratio ≥1.3 of progression free survival (PFS)/PFS of most recent treatment in patients with aggressive haematological malignancies
次要结局
- Average Ratio of PFS/PFS of most prior treatment(Through study completion, an average of 8 months)
- Overall response rate (ORR)(Through study completion, an average of 8 months)
- Number of treatable targets identified(Through study completion, an average of 8 months)
研究者
Philipp Staber, MD, PhD
Assoc. Prof. Priv.-Doz. Dr.med.univ. Philipp Staber
Medical University of Vienna