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Brief Title: A Study of MBG453 in Combination With Hypomethylating Agents in Subjects With IPSS-R Intermediate, High or Very High Risk Myelodysplastic Syndrome (MDS).
Official Title: A Randomized, Double-blind, Placebo-controlled Phase II Multi-center Study of Intravenous MBG453 Added to Hypomethylating Agents in Adult Subjects With Intermediate, High or Very High Risk Myelodysplastic Syndrome (MDS) as Per IPSS-R Criteria
Study ID: NCT03946670
Brief Summary: This Phase II is a multicenter, randomized, two-arm parallel-group, double-blind, placebo-controlled study of MBG453 or placebo added to hypomethylating agents (azacitidine or decitabine) in adult subjects with IPSS-R intermediate, high or very high risk myelodysplastic syndrome (MDS) not eligible for Hematopoietic Stem Cell Transplant (HSCT) or intensive chemotherapy.
Detailed Description: The 2 primary objectives are as follows: To determine if MBG453 combined with standard HMA therapy improves complete remission in subjects with intermediate, high, or very high risk MDS. To determine if MBG453 combined with standard HMA therapy improves progression free survival (PFS) in subjects with intermediate, high or very high risk MDS. This Phase II is a multicenter, randomized, two-arm parallel-group, double-blind, placebo-controlled study of MBG453 or placebo added to hypomethylating agents (azacitidine or decitabine, as per investigators' choice based on local standard of care (SOC)) in adult subjects with IPSS-R intermediate, high or very high risk MDS not eligible for HSCT or intensive chemotherapy. A total of 127 subjects were randomized in a 1:1 ratio to treatment arms as follows: MBG453 400 mg IV Q2W and decitabine or azacitidine Placebo IV Q2W and decitabine or azacitidine The randomization was stratified by 2 stratification factors: a) HMA (decitabine or azacitidine) selected by the investigator as per the local SOC and b) IPSS-R prognostic risk categories (intermediate, high or very high) at randomization. Crossover between treatment arms was not permitted at any time during the study.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
City of Hope National Medical Center Medical Oncology & Therapeutic, Duarte, California, United States
Yale University School Of Medicine, New Haven, Connecticut, United States
Dana Farber Cancer Institute Centerfor Sarcoma&BoneOncology, Boston, Massachusetts, United States
The Cancer Institute of New Jersey The Cancer Institute of NJ, New Brunswick, New Jersey, United States
Ohio State Comprehensive Cancer Center/James Cancer Hospital SC BCL201X2102C, Columbus, Ohio, United States
Mary Crowley Cancer Research, Dallas, Texas, United States
Novartis Investigative Site, Vienna, , Austria
Novartis Investigative Site, Brasschaat, , Belgium
Novartis Investigative Site, Leuven, , Belgium
Novartis Investigative Site, Toronto, Ontario, Canada
Novartis Investigative Site, Quebec, , Canada
Novartis Investigative Site, Brno - Bohunice, , Czechia
Novartis Investigative Site, Praha, , Czechia
Novartis Investigative Site, Toulouse, , France
Novartis Investigative Site, Berlin, , Germany
Novartis Investigative Site, Leipzig, , Germany
Novartis Investigative Site, Alexandroupolis, Evros, Greece
Novartis Investigative Site, Larissa, GR, Greece
Novartis Investigative Site, Patras, , Greece
Novartis Investigative Site, Hong Kong, , Hong Kong
Novartis Investigative Site, Debrecen, , Hungary
Novartis Investigative Site, Nyiregyhaza, , Hungary
Novartis Investigative Site, Firenze, FI, Italy
Novartis Investigative Site, Milano, MI, Italy
Novartis Investigative Site, Rozzano, MI, Italy
Novartis Investigative Site, Reggio Calabria, RC, Italy
Novartis Investigative Site, Roma, RM, Italy
Novartis Investigative Site, Fukuoka city, Fukuoka, Japan
Novartis Investigative Site, Fukushima city, Fukushima, Japan
Novartis Investigative Site, Gifu shi, Gifu, Japan
Novartis Investigative Site, Isehara, Kanagawa, Japan
Novartis Investigative Site, Kumamoto-city, Kumamoto, Japan
Novartis Investigative Site, Sendai-shi, Miyagi, Japan
Novartis Investigative Site, Nagasaki-city, Nagasaki, Japan
Novartis Investigative Site, Bunkyo ku, Tokyo, Japan
Novartis Investigative Site, Osaka, , Japan
Novartis Investigative Site, Seoul, , Korea, Republic of
Novartis Investigative Site, Seoul, , Korea, Republic of
Novartis Investigative Site, Malaga, Andalucia, Spain
Novartis Investigative Site, Santander, Cantabria, Spain
Novartis Investigative Site, Hospitalet de LLobregat, Catalunya, Spain
Novartis Investigative Site, Kaohsiung, , Taiwan
Novartis Investigative Site, Taipei, , Taiwan
Novartis Investigative Site, Izmir, , Turkey
Novartis Investigative Site, Kocaeli, , Turkey
Novartis Investigative Site, Samsun, , Turkey
Novartis Investigative Site, Manchester, , United Kingdom
Name: Novartis Pharmaceuticals
Affiliation: Novartis Pharmaceuticals
Role: STUDY_DIRECTOR