EUCTR2016-001657-41-GB进行中（未招募）1 期
A Randomized Phase 2 Study Evaluating the Safety, Pharmacokinetics and Efficacy of Venetoclax in Combination with Azacitidine Compared with Azacitidine Alone in Subjects with Treatment-Naïve Higher-Risk Myelodysplastic Syndromes (MDS)
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 90
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Subject must be = 18 years of age.
- •2. Subject must have documented diagnosis of de novo MDS with:
- •? International Prognostic Scoring System (IPSS) risk categories Int-2 or High (IPSS overall score = 1.5) and
- •? Presence of = 5% and < 30% bone marrow blasts per bone marrow
- •biopsy/aspirate at screening
- •3. Subject must have an Eastern Cooperative Oncology Group (ECOG) performance score of = 2.
- •4. Subject must have received no prior therapy for MDS.
- •NOTE: Patients who only received supportive care for MDS (e.g., transfusions, growth factors) are eligible to enrol in the study.
- •5. Subject is not a candidate to undergo intensive chemotherapy or allogeneic hematopoietic stem cell transplantation (HSCT).
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 20
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 70
排除标准
- •1. Subject has therapy-related MDS (t-MDS).
- •2. Subject has MDS evolving from a pre-existing myeloproliferative neoplasm (MPN).
- •3. Subject has MDS/MPN including chronic myelomonocytic leukemia (CMML), atypical chronic myelogenous leukemia (CML), juvenile myelomonocytic leukemia (JMML) and unclassifiable MDS/MPN.
- •4. Subject has received prior therapy with a BH3 mimetic.
- •5. Subject has received allogeneic HSCT or solid organ transplantation .
研究者
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