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 - STIMULUS-AML1

ovartis Pharma AG0 个研究点目标入组 86 人开始时间: 2020年12月10日最近更新: 2023年2月20日

试验速览

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•Inclusion Criteria:
•1.Signed informed consent must be obtained prior to participation in the study.
•2. Age = 18 years at the date of signing the informed consent form (ICF)
•3. Newly diagnosed with AML based on 2016 WHO classification (Arber et al 2016) and not suitable for intensive chemotherapy defined as: age =75, ECOG performance Status 2 or 3, or any of the following comorbidities: severe cardiac comorbidities (including congestive heart failure, LVEF = 50%, chronic stable Angina) , pulmonary comorbidity (DLCO = 65% or FEVI = 65%). moderate hepatic impairment (with total Bilirubin >1.5 to 3x ULN) , renal impairment (eGFR= 30 ml/min/1.73m^2 to 45 30 ml/min/1.73m^2), or other comorbidity incompatible with intensive chemotherapy per Investigator assessment and approved by the Novartis Medical monitor)
•4..Not planned for hematopoietic stem-cell transplantation (HSCT)
•5..Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 , 2 or 3
•Additional inclusion criteria as per full protocol may apply
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 6
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 80

•Exclusion Criteria:
•1.Prior exposure to TIM-3 directed therapy
•2. History of severe hypersensitivity reactions to any ingredient of study drug(s) (azacitidine, venetoclax or MGB453) or monoclonal antibodies (mAbs) and/or their excipients
•3.Current use or use 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.
•4.Previous treatment at any time, with any of the following antineoplastic agents, approved or investigational; checkpoint inhibitors, venetoclax and hypomethylating agents (HMAs) such as decitabine or azacitidine.
•5.Active autoimmune disease requiring systemic therapy (e.g.corticosteroids).
•6.Live vaccine administered within 30 days prior to randomization
•Other protocol-defined Inclusion/Exclusion may apply.

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