Spots Global Cancer Trial Database for A Study to Evaluate the Safety and Tolerability, Pharmacokinetics, Pharmacodynamics and Preliminary Efficacy of TJ011133 as Monotherapy and in Combination With Azacitidine (AZA) in Patients With Acute Myeloid Leukemia (AML) or Myelodysplastic Syndrome (MDS)
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Trial Identification
Brief Title: A Study to Evaluate the Safety and Tolerability, Pharmacokinetics, Pharmacodynamics and Preliminary Efficacy of TJ011133 as Monotherapy and in Combination With Azacitidine (AZA) in Patients With Acute Myeloid Leukemia (AML) or Myelodysplastic Syndrome (MDS)
Official Title: A Multicenter, Open-label, Phase 1/2a Study to Evaluate the Safety and Tolerability, Pharmacokinetics, Pharmacodynamics and Preliminary Efficacy of TJ011133 as Monotherapy and in Combination With Azacitidine (AZA) in Patients With Acute Myeloid Leukemia (AML) or Myelodysplastic Syndrome (MDS)
Study ID: NCT04202003
Interventions
Study Description
Brief Summary: This study is a phase I/II study of TJ011133 as Monotherapy and in Combination with Azacitidine (AZA) in Patients with Acute Myeloid Leukemia (AML) or Myelodysplastic Syndrome (MDS). This study include Phase I and Phase IIa study. Phase I study ClinicalTrials.gov ID is NCT04202003 and this is for phase IIa study. Phase IIa study is designed to preliminarily assess the efficacy and safety of TJ011133 in combination with AZA as first-line treatment in patients with newly diagnosed AML who are intolerant to standard induction chemotherapy or patients with treatment naive, intermediate and high-risk MDS.
Detailed Description:
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Peking Union Medical College Hospital, Beijing, Beijing, China
Peking University International Hospital, Beijing, Beijing, China
Beijing Boren Hospital, Beijing, Beijing, China
The First Affiliated Hospital of Chongqing Medical University, Chongqing, Chongqing, China
The First Affiliated Hospital of Xiamen University, Xiamen, Fujian, China
Guangdong Provincial People's Hospital, Guangzhou, Guangdong, China
Zhujiang Hospital Of Southern Medical University, Guangzhou, Guangdong, China
Nanfang Hospital, Guangzhou, Guangdong, China
Sun Yat-sen University Cancer Center, Guangzhou, Guangdong, China
Shenzhen Second People's Hospital, Shenzhen, Guangdong, China
The Affiliated Hospital of Guizhou Medical University, Guiyang, Guizhou, China
The Second Hospital of HeBei Medical University, Shijiazhuang, Hebei, China
Henan Cancer Hospital, Zhengzhou, Henan, China
Union Hospital affiliated to Tongji Medical College of Huazhong University of Science and Technology, Wuhan, Hubei, China
Jiangsu Province Hospital, Suzhou, Jiangsu, China
The First Hospital of Jilin University, Changchun, Jilin, China
The First Hospital of China Medical University, Shenyang, Liaoning, China
Qilu Hospital of Shandong University, Jinan, Shandong, China
Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, Shanghai, Shanghai, China
Shanghai Sixth People's Hospital, Shanghai, Shanghai, China
The Second Affiliated Hospital of Xi'an Jiaotong University（Xibei Hospital）, Xi'an, Shanxi, China
Institute of Hematology and Blood Disease Hospital, Chinese Academy of Medical, Tianjin, Tianjin, China
Tianjin Medical University General Hospital, Tianjin, Tianjin, China
The second Affiliated Hospital of Kunming Medical University, Kunming, Yunnan, China
The First Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, Zhejiang, China
The Second Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, Zhejiang, China
Contact Details
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