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Spots Global Cancer Trial Database for A Study of MBG453 in Combination With Hypomethylating Agents in Subjects With IPSS-R Intermediate, High or Very High Risk Myelodysplastic Syndrome (MDS).

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Trial Identification

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

Study Description

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.

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

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

Contact Details

Name: Novartis Pharmaceuticals

Affiliation: Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Useful links and downloads for this trial

Clinicaltrials.gov

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