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Spots Global Cancer Trial Database for Study of Efficacy and Safety of MBG453 in Combination With Azacitidine in Subjects With Intermediate, High or Very High Risk Myelodysplastic Syndrome (MDS) as Per IPSS-R, or Chronic Myelomonocytic Leukemia-2 (CMML-2)

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Trial Identification

Brief Title: Study of Efficacy and Safety of MBG453 in Combination With Azacitidine in Subjects With Intermediate, High or Very High Risk Myelodysplastic Syndrome (MDS) as Per IPSS-R, or Chronic Myelomonocytic Leukemia-2 (CMML-2)

Official Title: A Randomized, Double-blind, Placebo-controlled Phase III Multi-center Study of Azacitidine With or Without MBG453 for the Treatment of Patients With Intermediate, High or Very High Risk Myelodysplastic Syndrome (MDS) as Per IPSS-R, or Chronic Myelomonocytic Leukemia-2 (CMML-2)

Study ID: NCT04266301

Study Description

Brief Summary: This is a Phase III multi-center, randomized, two-arm parallel-group, double-blind, placebo-controlled study of MBG453 or placebo added to azacitidine in adult subjects with intermediate, high or very high-risk myelodysplastic syndrome (MDS) as per IPSS-R, or Chronic Myelomonocytic Leukemia-2 (CMML-2) who are not eligible for intensive chemotherapy or hematopoietic stem cell transplantation (HSCT) according to medical judgment by the investigator. The purpose of the current study is to assess clinical effects of MBG453 in combination with azacitidine in adult subjects with IPSS-R intermediate, high, very high risk MDS and CMML-2.

Detailed Description: This is a Phase III multi-center, randomized, two-arm parallel-group, double-blind, placebo controlled study of MBG453 or placebo added to azacitidine in adult subjects with intermediate, high or very high risk myelodysplastic syndrome (MDS) as per IPSS-R, or Chronic Myelomonocytic Leukemia-2 (CMML-2). The primary objective of this study is to compare overall survival (OS) in the MBG453 plus azacitidine arm versus placebo plus azacitidine arm where OS is the time from randomization until death due to any cause. Subjects will be randomized in a 1:1 ratio to treatment arms as follow: MBG453 800 mg IV Q4W plus azacytidine, Placebo IV Q4W plus azacitidine The randomization will be stratified into 4 groups: intermediate risk MDS, high risk MDS, very high risk MDS and CMML-2. All subjects who discontinue both study treatments will enter a long-term post-treatment follow-up including response and PRO assessments, and/or survival follow-up for up to 5 years after the last subject was randomized. Subjects will be treated until they experience progression of disease (including transformation to acute leukemia per WHO 2016 classification), experience unacceptable toxicity or discontinue the study treatment for other reasons. Continuation of study treatment beyond progression (excluding transformation to acute leukemia: continuation in this case is not possible) may be possible in selected subjects.

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Yuma Regional Cancer Center, Yuma, Arizona, United States

University Of California LA ., Los Angeles, California, United States

Yale University School Of Medicine Smilow Cancer Hospital, New Haven, Connecticut, United States

Mayo Clinic Jacksonville ., Jacksonville, Florida, United States

University Of Miami ., Miami, Florida, United States

Northwestern University Div of Hematology Oncology, Chicago, Illinois, United States

Massachusetts General Hospital ., Boston, Massachusetts, United States

Hackensack University Medical Ctr SC, Hackensack, New Jersey, United States

Weill Cornell Medicine NY-Presb ., New York, New York, United States

University of Rochester Medical Ctr Univ Rochester JP Wilmot, Rochester, New York, United States

University of Virginia University of Virginia, Charlottesville, Virginia, United States

Novartis Investigative Site, Pilar, Buenos Aires, Argentina

Novartis Investigative Site, Woolloongabba, Queensland, Australia

Novartis Investigative Site, Clayton, Victoria, Australia

Novartis Investigative Site, Perth, Western Australia, Australia

Novartis Investigative Site, Graz, , Austria

Novartis Investigative Site, Innsbruck, , Austria

Novartis Investigative Site, Linz, , Austria

Novartis Investigative Site, Brasschaat, , Belgium

Novartis Investigative Site, Roeselare, , Belgium

Novartis Investigative Site, Florianopolis, SC, Brazil

Novartis Investigative Site, Sao Paulo, SP, Brazil

Novartis Investigative Site, Sao Paulo, SP, Brazil

Novartis Investigative Site, Calgary, Alberta, Canada

Novartis Investigative Site, Toronto, Ontario, Canada

Novartis Investigative Site, Vina del Mar, Valparaiso, Chile

Novartis Investigative Site, Guangzhou, Guangdong, China

Novartis Investigative Site, Guangzhou, Guangdong, China

Novartis Investigative Site, Shenzhen, Guangdong, China

Novartis Investigative Site, Wuhan, Hubei, China

Novartis Investigative Site, Wuhan, Hubei, China

Novartis Investigative Site, Suzhou, Jiangsu, China

Novartis Investigative Site, Chang Chun, Jilin, China

Novartis Investigative Site, Hangzhou, Zhejiang, China

Novartis Investigative Site, Beijing, , China

Novartis Investigative Site, Beijing, , China

Novartis Investigative Site, Chengdu, , China

Novartis Investigative Site, Jinan, , China

Novartis Investigative Site, Shanghai, , China

Novartis Investigative Site, Shanghai, , China

Novartis Investigative Site, Tianjin, , China

Novartis Investigative Site, Tianjin, , China

Novartis Investigative Site, Rionegro, Antioquia, Colombia

Novartis Investigative Site, Bogota, , Colombia

Novartis Investigative Site, Praha 2, Czech Republic, Czechia

Novartis Investigative Site, Hradec Kralove, CZE, Czechia

Novartis Investigative Site, Brno - Bohunice, , Czechia

Novartis Investigative Site, Praha, , Czechia

Novartis Investigative Site, Helsinki, , Finland

Novartis Investigative Site, Kuopio, , Finland

Novartis Investigative Site, Grenoble, , France

Novartis Investigative Site, Lille, , France

Novartis Investigative Site, Paris 10, , France

Novartis Investigative Site, Toulouse, , France

Novartis Investigative Site, Tours, , France

Novartis Investigative Site, Vandoeuvre Les Nancy, , France

Novartis Investigative Site, Velbert, North Rhine-Westphalia, Germany

Novartis Investigative Site, Dresden, Sachsen, Germany

Novartis Investigative Site, Augsburg, , Germany

Novartis Investigative Site, Duesseldorf, , Germany

Novartis Investigative Site, Frankfurt, , Germany

Novartis Investigative Site, Greifswald, , Germany

Novartis Investigative Site, Jena, , Germany

Novartis Investigative Site, Kiel, , Germany

Novartis Investigative Site, Ulm, , Germany

Novartis Investigative Site, Alexandroupolis, Evros, Greece

Novartis Investigative Site, Patras, , Greece

Novartis Investigative Site, Ahmedabad, Gujrat, India

Novartis Investigative Site, Faridabad, Haryana, India

Novartis Investigative Site, Madurai, Tamil NADU, India

Novartis Investigative Site, Kolkata, West Bengal, India

Novartis Investigative Site, Kolkata, West Bengal, India

Novartis Investigative Site, Delhi, , India

Novartis Investigative Site, Afula, , Israel

Novartis Investigative Site, Tel Aviv, , Israel

Novartis Investigative Site, Bologna, BO, Italy

Novartis Investigative Site, Catania, CT, Italy

Novartis Investigative Site, Firenze, FI, Italy

Novartis Investigative Site, Genova, GE, 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, Nagoya, Aichi, Japan

Novartis Investigative Site, Kashiwa, Chiba, Japan

Novartis Investigative Site, Fukuoka city, Fukuoka, Japan

Novartis Investigative Site, Sapporo, Hokkaido, Japan

Novartis Investigative Site, Isehara, Kanagawa, Japan

Novartis Investigative Site, Sendai city, Miyagi, Japan

Novartis Investigative Site, Nagasaki-city, Nagasaki, Japan

Novartis Investigative Site, Osaka Sayama, Osaka, Japan

Novartis Investigative Site, Bunkyo-ku, Tokyo, Japan

Novartis Investigative Site, Osaka, , Japan

Novartis Investigative Site, Yamagata, , Japan

Novartis Investigative Site, Seoul, Seocho Gu, Korea, Republic of

Novartis Investigative Site, Seoul, , Korea, Republic of

Novartis Investigative Site, Seoul, , Korea, Republic of

Novartis Investigative Site, Seoul, , Korea, Republic of

Novartis Investigative Site, Seoul, , Korea, Republic of

Novartis Investigative Site, Beirut, , Lebanon

Novartis Investigative Site, Vilnius, , Lithuania

Novartis Investigative Site, Kuching, Sarawak, Malaysia

Novartis Investigative Site, Kuala Lumpur, , Malaysia

Novartis Investigative Site, Pulau Pinang, , Malaysia

Novartis Investigative Site, Selangor, , Malaysia

Novartis Investigative Site, Mexico, Distrito Federal, Mexico

Novartis Investigative Site, Satelite, Edo Mexico, Mexico

Novartis Investigative Site, Morelia, Michoacan, Mexico

Novartis Investigative Site, Estado de Mexico, , Mexico

Novartis Investigative Site, Groningen, , Netherlands

Novartis Investigative Site, Muscat, , Oman

Novartis Investigative Site, Lisboa, , Portugal

Novartis Investigative Site, Porto, , Portugal

Novartis Investigative Site, Saint Petersburg, , Russian Federation

Novartis Investigative Site, St Petersburg, , Russian Federation

Novartis Investigative Site, Riyadh, , Saudi Arabia

Novartis Investigative Site, Singapore, , Singapore

Novartis Investigative Site, Singapore, , Singapore

Novartis Investigative Site, Sevilla, Andalucia, Spain

Novartis Investigative Site, Oviedo, Asturias, Spain

Novartis Investigative Site, Salamanca, Castilla Y Leon, Spain

Novartis Investigative Site, Badalona, Catalunya, Spain

Novartis Investigative Site, Barcelona, Catalunya, Spain

Novartis Investigative Site, Valencia, Comunidad Valenciana, Spain

Novartis Investigative Site, Madrid, , Spain

Novartis Investigative Site, Valencia, , Spain

Novartis Investigative Site, Bern, , Switzerland

Novartis Investigative Site, Zürich, , Switzerland

Novartis Investigative Site, Hualien City, Hualien, Taiwan

Novartis Investigative Site, Kaohsiung, , Taiwan

Novartis Investigative Site, Liouying Township, , Taiwan

Novartis Investigative Site, Taichung, , Taiwan

Novartis Investigative Site, Taipei, , Taiwan

Novartis Investigative Site, Taoyuan, , Taiwan

Novartis Investigative Site, Songkhla, Hat Yai, Thailand

Novartis Investigative Site, Khon Kaen, THA, Thailand

Novartis Investigative Site, Bangkok, , Thailand

Novartis Investigative Site, Bangkok, , Thailand

Novartis Investigative Site, Bangkok, , Thailand

Novartis Investigative Site, Chiang Mai, , Thailand

Novartis Investigative Site, Ankara, , Turkey

Novartis Investigative Site, Edirne, , Turkey

Novartis Investigative Site, Istanbul, , Turkey

Novartis Investigative Site, Izmir, , Turkey

Novartis Investigative Site, Samsun, , Turkey

Novartis Investigative Site, Portsmouth, Hants, United Kingdom

Novartis Investigative Site, Edinburgh, , United Kingdom

Novartis Investigative Site, Manchester, , United Kingdom

Novartis Investigative Site, Nottingham, , 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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