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临床试验/CTIS2024-514688-24-00
CTIS2024-514688-24-00招募中1 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 - FLAMSAClax

Heinrich-Heine-Universitaet Duesseldorf0 个研究点目标入组 38 人开始时间: 2024年7月9日最近更新:

试验速览

阶段
1 期
状态
招募中
发起方
入组人数
38

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional

入排标准

年龄范围
18 至 65+(—)
性别
All

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

研究者

发起方
Heinrich-Heine-Universitaet Duesseldorf

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