Acute Myeloid Leukemia Clinical Trial

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

Summary

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

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Full Description

The primary purpose of Part 1 (Safety Run-in) is to rule out excessive toxicity of MBG453, when administered in combination with azacitidine and venetoclax.

The primary purpose of the combined Part 1 and Part 2 (Safety run-in and Expansion Part) is to evaluate efficacy of MBG453, when administered in combination with azacitidine and venetoclax in adult patients with newly diagnosed AML, who are not suitable for treatment with intensive chemotherapy.

There will be an analyis of the CR rate, after all subjects have completed at least 12 cycles of treatment ( cycle =28Days) or discontinued earlier.

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Eligibility Criteria

Inclusion Criteria:

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 30 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

Exclusion Criteria:

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

Other protocol-defined Inclusion/Exclusion may apply.

Study is for people with:

Acute Myeloid Leukemia

Phase:

Phase 2

Estimated Enrollment:

90

Study ID:

NCT04150029

Recruitment Status:

Active, not recruiting

Sponsor:

Novartis Pharmaceuticals

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There are 28 Locations for this study

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25Uni of Alabama at Birmingham
Birmingham Alabama, 35294, United States
Yale University School Of Medicine .
New Haven Connecticut, 06520, United States
University of Iowa Hospitals and Clinics Univ of Iowa
Iowa City Iowa, 52242, United States
Dana Farber Cancer Institute Dana Farber Cancer Int
Boston Massachusetts, 02215, United States
Mayo Clinic Rochester Dept. of Mayo Clinic (2)
Rochester Minnesota, 55905, United States
Memorial Sloan Kettering Dept. of MSKCC
New York New York, 10017, United States
Weill Cornell Medicine NY-Presb .
New York New York, 10021, United States
Levine Cancer Insitute Carolinas Healthcare System
Charlotte North Carolina, 28204, United States
Duke Univ Medical Center .
Durham North Carolina, 27710, United States
Chattanooga Oncology and Hematology Associates PC Tennessee Oncology Chattanooga
Chattanooga Tennessee, 37404, United States
MD Anderson Cancer Center/University of Texas MD Anderson
Houston Texas, 77030, United States
Huntsman Cancer Institute Univ of Utah .
Salt Lake City Utah, 84112, United States
Novartis Investigative Site
Clayton Victoria, 3168, Australia
Novartis Investigative Site
Vancouver British Columbia, V5Z 1, Canada
Novartis Investigative Site
Toronto Ontario, M5G 1, Canada
Novartis Investigative Site
Montreal Quebec, H3T 1, Canada
Novartis Investigative Site
Paris 10 , 75475, France
Novartis Investigative Site
Toulouse , 31059, France
Novartis Investigative Site
Berlin , 13353, Germany
Novartis Investigative Site
Leipzig , 04103, Germany
Novartis Investigative Site
Milano MI, 20162, Italy
Novartis Investigative Site
Roma RM, 00133, Italy
Novartis Investigative Site
Fukushima city Fukushima, 960 1, Japan
Novartis Investigative Site
Yamagata , 990 9, Japan
Novartis Investigative Site
Seoul Seocho Gu, 06591, Korea, Republic of
Novartis Investigative Site
Barcelona Catalunya, 08036, Spain
Novartis Investigative Site
Madrid , 28009, Spain
Novartis Investigative Site
Kaohsiung , 83301, Taiwan

How clear is this clinincal trial information?

Study is for people with:

Acute Myeloid Leukemia

Phase:

Phase 2

Estimated Enrollment:

90

Study ID:

NCT04150029

Recruitment Status:

Active, not recruiting

Sponsor:


Novartis Pharmaceuticals

How clear is this clinincal trial information?

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