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IMM01+Azacitidine VS Placebo +Azacitidine in Patients With Newly Diagnosed Chronic Myelomonocytic Leukemia (CMML1-2)

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研究单位: [1]ImmuneOnco Biopharmaceuticals (Shanghai) Inc. [2]Anhui Provincial Hospital,Hefei,Anhui,China [3]China-Japan Friendship Hospita,Beijing,Beijing,China [4]The First Affiliated Hospital of Chongqing Medical University,Chongqing,Chongqing,China [5]First Hospital of Lanzhou University,Lanzhou,Gansu,China [6]The First Affiliated Hospital of Guangxi Medical University,Nanning,Gaungxi,China [7]Nanfang Hospital, Southern Medical University,Guangzhou,Guangdong,China [8]Shenzhen Second People''s Hospital,Shenzhen,Guangdong,China [9]Zhujiang Hospital of Southern Medical University,Zhujiang,Guangdong,China [10]Guangdong Provincial People''s Hospital,Guangzhou,Guangzhou,China [11]Affiliated Hospital of Guizhou Medical University,Guiyang,Guizhou,China [12]Affiliated Hospital of Hebei University,Shijiazhuang,Hebei,China [13]The Second Hospital of Hebei Medical University,Shijiazhuang,Hebei,China [14]Harbin First Hospital,Harbin,Heilongjiang,China [15]First Affiliated Hospital of Zhengzhou University,Zhengzhou,Henan,China [16]Henan Cancer Hospital,Zhengzhou,Henan,China [17]Henan Provincial People''s Hospital,Zhengzhou,Henan,China [18]The First Affiliated Hospital of Henan University of Science and Technology,Zhengzhou,Henan,China [19]Union Hospital Affiliated to Tongji Medical College, Huazhong University of Science and Technology,Wuhan,Hubei,China [20]Zhongnan Hospital Affiliated to Wuhan University,Wuhan,Hubei,China [21]Xiangyang Central Hospital,Xiangyang,Hubei,China [22]Xiangya Hospital Central South University,Changsha,Hunan,China [23]Changzhou First People''s Hospital,Changzhou,Jiangsu,China [24]Jiangsu Province Hospital,Nanjing,Jiangsu,China [25]Zhongda Hospital affiliated to Southeast University,Nanjing,Jiangsu,China [26]The First Affiliated Hospital of Soochow University,Suzhou,Jiangsu,China [27]Affiliated Hospital of Xuzhou Medical University,Xuzhou,Jiangsu,China [28]Jiangsu Subei People''s Hospital,Yangzhou,Jiangsu,China [29]The First Affiliated Hospital of Nanchang University,Nanchang,Jiangxi,China [30]The First Hospital of Jilin University,Changchun,Jilin,China [31]Shengjing Hospital of China Medical University,Shenyang,Liaoning,China [32]The First Hospital of China Medical University,Shenyang,Liaoning,China [33]Qilu Hospital of Shandong University,Jinan,Shandong,China [34]Shaanxi Provincial People''s Hospital,Xi''an,Shanxi,China [35]Sichuan Provincial People''s Hospital,Chengdu,Sichuan,China [36]Yibin Second People''s Hospital,Yibin,Sichuan,China [37]Institute of Hematology and Blood Disease Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College [38],Tianjin,Tianjin,China,300020 [39]The First Affiliated Hospital of Xinjiang Medical University,Ürümqi,Xinjiang,China [40]The Second Affiliated Hospital of Kunming Medical University,Kunming,Yunnan,China [41]The First Affiliated Hospital, Zhejiang University School of Medicine,Hangzhou,Zhejiang,China,310003 [42]Ningbo First Hospital,Ningbo,Zhejiang,China [43]The First Affiliated Hospital of Wenzhou Medical University,Wenzhou,Zhejiang,China [44]Peking University People''s Hospital,Beijing,China [45]Tianjin People''s Hospital,Tianjin,China

研究目的:
This study is a randomized, controlled, double-blind, multicenter, phase Ⅲ clinical study to evaluate the efficacy of IMM01(timdarpacept) in combination with azacitidine versus placebo in combination with azacitidine in patients with newly diagnosed chronic leukemia monocytic (CMML1-2).Primary endpoint are Complete remission rate and Overall survival.

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