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)

AbbVie Deutschland GmbH & Co. KG0 个研究点目标入组 500 人开始时间: 2020年10月1日最近更新: 2023年9月18日

适应症

试验速览

暂无简介。

•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.
•For further information on the inclusion criteria, please refer to section 5.2 Eligibility Criteria of the Study Protocol.
•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 300
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 200

•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 cyclosporine are also excluded as these are considered disease-modifying agents.
•No known active SARS-CoV-2 infection. If a subject has signs/symptoms suggestive of SARS-CoV-2 infection, they should undergo molecular (e.g. PCR) testing to rule out of SARS-CoV-2 infection.
•For further information on the exclusion criteria, please refer to section 5.2 Eligibility Criteria of the Study Protocol.

发起方