Spots Global Cancer Trial Database for A Study of MBG453 in Combination With Azacitidine and Venetoclax in AML Patients Unfit for Chemotherapy
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Trial Identification
Brief Title: A Study of MBG453 in Combination With Azacitidine and Venetoclax in AML Patients Unfit for Chemotherapy
Official Title: A Phase II Multi-center, Single Arm, Safety and Efficacy Study of MBG453 in Combination With Azacitidine and Venetoclax for the Treatment of Acute Myeloid Leukemia (AML) in Adult Patients Unfit for Chemotherapy
Study ID: NCT04150029
Conditions
Study Description
Brief Summary: This trial will seek to extend the preliminary findings of efficacy of MBG453 in combination with hypomethylating agents (HMA) by evaluating MBG453 in combination with the HMA azacitidine and the Bcl-2 inhibitor venetoclax.
Detailed Description: The primary purpose of Part 1 (Safety Run-in) is to rule out excessive toxicity of MBG453, when administered in combination with azacitidine and venetoclax. The primary purpose of the combined Part 1 and Part 2 (Safety run-in and Expansion Part) is to evaluate efficacy of MBG453, when administered in combination with azacitidine and venetoclax in adult patients with newly diagnosed AML, who are not suitable for treatment with intensive chemotherapy. There will be an analyis of the CR rate, after all subjects have completed at least 12 cycles of treatment ( cycle =28Days) or discontinued earlier.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
25Uni of Alabama at Birmingham, Birmingham, Alabama, United States
Yale University School Of Medicine ., New Haven, Connecticut, United States
Uni of Iowa Hospitals and Clinics Univ of Iowa Hosp and Clinic, Iowa City, Iowa, United States
Dana Farber Cancer Institute Dana Farber Cancer Int, Boston, Massachusetts, United States
Mayo Clinic Rochester Dept of Mayo Clinic 2, Rochester, Minnesota, United States
Memorial Sloan Kettering Dept. of MSKCC, New York, New York, United States
Weill Cornell Medicine NY-Presb ., New York, New York, United States
Levine Cancer Insitute Carolinas Healthcare System, Charlotte, North Carolina, United States
Duke Univ Medical Center ., Durham, North Carolina, United States
Chattanooga Onc And Hem Assoc PC Tennessee Oncology Chattanooga, Chattanooga, Tennessee, United States
MD Anderson Cancer Center/University of Texas MD Anderson, Houston, Texas, United States
Huntsman Cancer Institute Univ of Utah ., Salt Lake City, Utah, United States
Novartis Investigative Site, Clayton, Victoria, Australia
Novartis Investigative Site, Vancouver, British Columbia, Canada
Novartis Investigative Site, Toronto, Ontario, Canada
Novartis Investigative Site, Montreal, Quebec, Canada
Novartis Investigative Site, Paris 10, , France
Novartis Investigative Site, Toulouse, , France
Novartis Investigative Site, Berlin, , Germany
Novartis Investigative Site, Leipzig, , Germany
Novartis Investigative Site, Milano, MI, Italy
Novartis Investigative Site, Roma, RM, Italy
Novartis Investigative Site, Fukushima city, Fukushima, Japan
Novartis Investigative Site, Yamagata, , Japan
Novartis Investigative Site, Seoul, Seocho Gu, Korea, Republic of
Novartis Investigative Site, Barcelona, Catalunya, Spain
Novartis Investigative Site, Madrid, , Spain
Novartis Investigative Site, Kaohsiung, , Taiwan
Contact Details
Name: Novartis Pharmaceuticals
Affiliation: Novartis Pharmaceuticals
Role: STUDY_DIRECTOR
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