2024-514688-24-00招募中2 期
Phase-I/II trial to assess the safety and efficacy of Venetoclax in addition to sequential conditioning with Fludarabine / Amsacrine / Ara-C (FLAMSA) + Treosulfan for allogeneic blood stem cell transplantation in patients with MDS, CMML or sAML
Heinrich-Heine-Universitaet Duesseldorf6 个研究点 分布在 1 个国家目标入组 38 人开始时间: 2024年7月25日最近更新:
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 38
- 试验地点
- 6
- 主要终点
- safety, defined as the maximal organ toxicity to each organ system according to CTC criteria as well as the number of AEs of grade III or greater until day +30 (± 3) after transplantation
研究概览
简要总结
To find the MTD of Venetoclax when added to Fludarabin, Amsacrine and Ara-C + Treosulfan and evaluate , whether the addition of Venetoclax to sequential conditioning with Fludarabine + Amsacrine + Ara-C (FLAMSA) + Treosulfan for allogeneic blood stem cell transplantation in patients with high-risk MDS, CMML or sAML (FLAMSAClax) is safe
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 主要目的
- Follow-up period
- 盲法
- None
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 是
入选标准
- •MDS, CMML or sAML according to WHO classification (revised version 2016) with a marrow blast count >5% and/or high-risk genetic features (eg. bad risk karyotype according to the IPSS-R / ELN classification or presence of unfavorable somatic mutations (e.g. TP53, RUNX1, IDH1, IDH2, KMT2A, DEK-NUP214 or RAS pathway mutations including NRAS, KRAS, PTPN11, CBL, NF1, RIT1 or KIT), falling into the "high" or "very high" risk category of the IPSS-R or IPSS M) any time between diagnosis and inclusion.
排除标准
- •previous cytotoxic therapy exceeding oral Hydroxyurea or >2 courses of treatment with Azacytidine, Decitabine or low dose Ara-C alone or in combination with Venetoclax
结局指标
主要结局
safety, defined as the maximal organ toxicity to each organ system according to CTC criteria as well as the number of AEs of grade III or greater until day +30 (± 3) after transplantation
safety, defined as the maximal organ toxicity to each organ system according to CTC criteria as well as the number of AEs of grade III or greater until day +30 (± 3) after transplantation
次要结局
- incidence, course und severity of aGvHD and cGvHD during the first 2 years after transplantation
- safety, defined as the maximal organ toxicity to each organ system according to CTC criteria as well as the number of AEs of grade III or greater until day +100 (± 7) after transplantation
- graft failure defined as no donor chimerism at day +30 (± 3) after transplantation
- incidence, course and severity of VOD
- time (days from day 0) to hematopoietic reconstitution (ANC>500/µl, PLT>20000/µl and PLT>50000/µl)
- time (days from day 0) to transfusion independence
- best disease response within the first 100 days (± 7) after transplantation (according to IWG-criteria for MDS and ELN-criteria for AML)
- disease response and donor chimerism at day +30 (± 3), +60 (± 7) and +100 (± 7) after transplantation (according to IWG-criteria for MDS and ELN-criteria for AML)
- time (days from day 0) to complete donor chimerism in blood and marrow
- disappearance of molecular markers of disease (yes/no, time in days from day 0 )
- event-free survival (EFS, death, relapse and disease progression will be recorded as event)
- cumulative incidence of relapse (CIR, disease progression and relapse will be recorded as event)
- overall survival (OS, death will be recorded as event)
研究者
Prof. Guido Kobbe
Scientific
Heinrich-Heine-Universitaet Duesseldorf
研究点 (6)
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