Myelodysplastic Syndrome Clinical Trial
A Study of MBG453 in Combination With Hypomethylating Agents in Subjects With IPSS-R Intermediate, High or Very High Risk Myelodysplastic Syndrome (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) 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.
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.
Signed informed consent must be obtained prior to participation in the study.
Age ≥ 18 years at the date of signing the informed consent form (ICF)
Morphologically confirmed diagnosis of a myelodysplastic syndrome (MDS) based on 2016 WHO classification (Arber et al 2016) by investigator assessment with one of the following Prognostic Risk Categories, based on the International Prognostic Scoring System (IPSS-R):
Intermediate with at least ≥ 5% bone marrow blast
Not eligible at the time of screening, for intensive chemotherapy according to the investigator, based on local standard medical practice and institutional guidelines for treatment decisions
Not eligible at the time of screening, for hematopoietic stem-cell transplantation (HSCT) according to the investigator, based on local standard medical practice and institutional guidelines for treatment decisions.
Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2
Prior exposure to TIM-3 directed therapy at any time. Prior therapy with immune check point inhibitors (e.g. anti-CTLA4, anti-PD-1, anti-PD-L1, or anti-PD-L2), cancer vaccines are allowed except if the drug was administered within 4 months prior to randomization.
Previous first-line treatment for higher risk MDS with chemotherapy or any other antineoplastic agents including lenalidomide and hypomethylating agent (HMAs) such as decitabine or azacitidine.
History of severe hypersensitivity reactions to any ingredient of the study treatment (azacitidine, decitabine or MGB453) or their excipients, or to monoclonal antibodies (mAbs).
Currently using or used within 14 days prior to randomization of systemic, steroid therapy (> 10 mg/day prednisone or equivalent) or any immunosuppressive therapy. Topical, inhaled, nasal, ophthalmic steroids are allowed. Replacement therapy, steroids given in the context of a transfusion are allowed and not considered a form of systemic treatment.
Investigational treatment for MDS received within 4 weeks prior to randomization. In case of a checkpoint inhibitor: 4 months minimum prior to randomization interval is necessary to allow enrollment.
Active autoimmune disease requiring systemic therapy (e.g.corticosteroids).
Live vaccine administered within 30 Days prior to randomization.
Other protocol-defined Inclusion/Exclusion may apply.
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There are 46 Locations for this study
Duarte California, 91010, United States
New Haven Connecticut, 06520, United States
Boston Massachusetts, 02215, United States
New Brunswick New Jersey, 08901, United States
Columbus Ohio, 73210, United States
Dallas Texas, 75251, United States
Vienna , 1140, Austria
Brasschaat , 2930, Belgium
Leuven , 3000, Belgium
Toronto Ontario, M5G 1, Canada
Quebec , G1J 1, Canada
Brno - Bohunice , 625 0, Czechia
Praha , 12808, Czechia
Toulouse , 31059, France
Berlin , 13353, Germany
Leipzig , 04103, Germany
Alexandroupolis Evros, 681 0, Greece
Larissa GR, 411 1, Greece
Patras , 265 0, Greece
Hong Kong , , Hong Kong
Debrecen , 4032, Hungary
Nyiregyhaza , 4400, Hungary
Firenze FI, 50134, Italy
Milano MI, 20162, Italy
Rozzano MI, 20089, Italy
Reggio Calabria RC, 89124, Italy
Roma RM, 00133, Italy
Fukuoka city Fukuoka, 812-8, Japan
Fukushima city Fukushima, 960 1, Japan
Gifu shi Gifu, 500 8, Japan
Isehara Kanagawa, 259-1, Japan
Kumamoto-city Kumamoto, 860-0, Japan
Sendai-shi Miyagi, 983 8, Japan
Nagasaki-city Nagasaki, 852-8, Japan
Bunkyo ku Tokyo, 113-8, Japan
Osaka , 545-8, Japan
Seoul , 03080, Korea, Republic of
Seoul , 06351, Korea, Republic of
Malaga Andalucia, 29010, Spain
Santander Cantabria, 39008, Spain
Hospitalet de LLobregat Catalunya, 08907, Spain
Kaohsiung , 83301, Taiwan
Taipei , 10002, Taiwan
Izmir , 35040, Turkey
Kocaeli , 41380, Turkey
Samsun , 55139, Turkey
Manchester , M20 4, United Kingdom
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