A Study of MBG453 in Combination With Azacitidine and Venetoclax in AML Patients Unfit for Chemotherapy

Stopped early · Phase 2

Conditions studied: Acute Myeloid Leukemia

In brief

This trial seeked to extend the preliminary findings of efficacy by evaluating MBG453 in combination with hypomethylating agents (HMA) and also Bcl-2 inhibitor venetoclax.

Key facts

Study ID

NCT04150029

Run by

Novartis Pharmaceuticals

People needed

90

Starts

2020-09-01

Expected to finish

2024-10-25

Last updated by the study team

2026-01-13

Who can join

Age: 18 and older, up to 100. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)
• 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 comomorbitities: severe cardiac comorbities (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 ml/min/1.73m\^2), or other comorbidity incompatible with intensive chemotherapy per Investigator assessement and approved by the Novartis Medical monitor)
• Not planned for hematopoietic stem-cell transplantation (HSCT)
• Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 , 2 or 3

You may not qualify if…

• Prior exposure to TIM-3 directed therapy
• History of severe hypersensitivity reactions to any ingredient of study drug(s) (azacitidine, venetoclax or MGB453) or monoclonal antibodies (mAbs) and/or their excipients
• 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.
• 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.
• Active autoimmune disease requiring systemic therapy (e.g.corticosteroids).
• Live vaccine administered within 30 Days prior to randomization

Where it is running

• 25Uni of Alabama at Birmingham — Birmingham, Alabama, United States
• Yale University School Of Medicine — New Haven, Connecticut, United States
• Uni Of Iowa Hospitals And Clinics — Iowa City, Iowa, United States
• Dana Farber Cancer Institute — Boston, Massachusetts, United States
• Mayo Clinic Rochester — Rochester, Minnesota, United States
• Memorial Sloan Kettering — New York, New York, United States
• Weill Cornell Medicine NY-Presb — New York, New York, United States
• Levine Cancer Insitute Carolinas Healthcare System — Charlotte, North Carolina, United States
• Duke Univ Medical Center — Durham, North Carolina, United States
• Chattanooga Onc And Hem Assoc PC — Chattanooga, Tennessee, United States
• MD Anderson Cancer Center University of Texas — Houston, Texas, United States
• Huntsman Cancer Institute Univ of Utah — Salt Lake City, Utah, United States
• Novartis Investigative Site — Clayton, Victoria, Australia
• Novartis Investigative Site — Vancouver, British Columbia, Canada
• Novartis Investigative Site — Toronto, Ontario, Canada
• Novartis Investigative Site — Montreal, Quebec, Canada
• Novartis Investigative Site — Paris, France
• Novartis Investigative Site — Toulouse, France
• Novartis Investigative Site — Leipzig, Saxony, Germany
• Novartis Investigative Site — Berlin, Germany
• Novartis Investigative Site — Milan, MI, Italy
• Novartis Investigative Site — Roma, RM, Italy
• Novartis Investigative Site — Fukushima, Fukushima, Japan
• Novartis Investigative Site — Yamagata, Yamagata, Japan
• Novartis Investigative Site — Seoul, Seocho gu, South Korea

Full record on ClinicalTrials.gov

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