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Brief Title: A Study of Cusatuzumab Plus Azacitidine in Japanese Participants With Newly Diagnosed Acute Myeloid Leukemia or High-risk Myelodysplastic Syndrome Who Are Not Candidates for Intensive Treatment
Official Title: A Phase 1 Study of Cusatuzumab Plus Azacitidine in Japanese Patients With Newly Diagnosed Acute Myeloid Leukemia or High-risk Myelodysplastic Syndrome Who Are Not Candidates for Intensive Treatment
Study ID: NCT04241549
Brief Summary: The purpose of this study is to determine the recommended Phase 2 dose and evaluate safety profile of cusatuzumab in combination with azacitidine in Japanese participants with treatment naïve acute myeloid leukemia (AML) who are not candidates for intensive treatment.
Detailed Description:
Minimum Age: 20 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Fukushima Medical University Hospital, Fukushima, , Japan
Gunmaken Saiseikai Maebashi Hospital, Maebashi, , Japan
Osaka City General Hospital, Osaka, , Japan
NTT Medical Center Tokyo, Tokyo, , Japan
University of Fukui Hospital, Yoshida, , Japan
Name: Janssen Pharmaceutical K.K., Japan Clinical Trial
Affiliation: Janssen Pharmaceutical K.K.
Role: STUDY_DIRECTOR