An open-label, single-arm, pilot study of Venetoclax in combination with 5 days Azacitidine in treatment-nai¨ve subjects with acute myelogenous leukemia who are =18 years of age and not eligible for standard induction therapy (VENAZA-5S PILOT TRIAL) - VENAZA-5S

niversity of Leipzig0 个研究点目标入组 45 人开始时间: 2022年11月15日最近更新: 2024年8月21日

适应症

试验速览

暂无简介。

•Confirmed diagnosis of AML by WHO criteria 2016 AND ineligible for treatment with a standard cytarabine and anthracycline induction regimen due to age or comorbidities, Age = 18 years, Projected life expectancy of at least 12 weeks, Adequate renal and liver function

•Prior treatment for AML or MDS with one of the following: HMA, Chemotherapeutic agent, CAR-T cell therapy, Experimental therapies; (NOTE: Prior use of hydroxyurea is allowed), History of other malignancies with the exception of adequately treated in situ carcinoma of the cervix uteri or carcinoma in situ of breast; Basal cell carcinoma of the skin or localized squamous cell carcinoma of the skin; previous malignancy confined and surgically resected (or treated with other modalities) with curative intent, History of myeloproliferative neoplasm (MPN), Diagnosis of acute promyelocytic leukemia (APL), Presence of favorable-risk karyotype abnormalities, i.e. t(15;17), t(8;21), inv(16) or t(16;16), Known active CNS involvement with AML, Known to be positive for HIV, Hepatitis B or C, Cardiovascular disability status of NYHA > 2, Chronic respiratory disease that requires continuous oxygen, or significant history of renal, neurologic, psychiatric, endocrinologic, metabolic, immunologic, hepatic, cardiovascular disease, or any other medical condition that in the opinion of the investigator would adversely affect his/her participating in this study, Evidence of other clinically significant uncontrolled systemic infection requiring therapy (viral, bacterial or fungal)

发起方

niversity of Leipzig