NL-OMON54378尚未招募3 期
A Randomized, Double-Blind, Phase 3 Study Evaluating the Safety and Efficacy of Venetoclax in Combination with Azacitidine in Patients Newly Diagnosed with Higher-Risk Myelodysplastic Syndrome (Higher-Risk MDS) - VERONA
适应症
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 13
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 99（—）
入选标准
- •Adult male or female, at least 18 years old. Diagnosis of MDS according to the
- •2016 WHO classification with presence of < 20% bone marrow blasts per bone
- •marrow biopsy/aspirate at screening. Subject meets the following disease
- •activity criteria:
- •* Overall IPSS-R score > 3 (intermediate, high, or very high; Appendix E);
- •* Eastern Cooperative Oncology Group (ECOG) performance status <= 2;
- •* HSCT eligible with no pre-arranged HSCT at the time of Study Day 1, or HSCT
- •ineligible without plan for HSCT at the time of Study Day 1. No prior therapy
- •for MDS with any hypomethylating agent (for example, azacitidine, decitabine),
- •chemotherapy or allogeneic stem cell transplantation.
排除标准
- •No previous diagnosis of:
- •* Therapy-related MDS (t-MDS)
- •* MDS evolving from a pre-existing myeloproliferative neoplasm (MPN)
- •* MDS/MPN including chronic myelomonocytic leukemia (CMML), atypical chronic
- •myeloid leukemia (aCML), juvenile myelomonocytic leukemia (JMML) and
- •unclassifiable MDS/MPN
- •* No prior therapy for MDS with any hypomethylating agent (for example,
- •azacitidine, decitabine), chemotherapy or allogeneic stem cell transplantation.
- •Lenalidomide, anti-thymocyte globulin (ATG), and cyclosporin are also excluded
- •as these are considered disease-modifying agents.
- •* No known active SARS-CoV-2 infection. If a subject has signs/symptoms of
- •SARS-CoV-2 infection, they should undergo molecular (e.g., PCR) testing to rule
- •out SARS-CoV-2 infection.
研究者
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