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

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

ClinicalTrials.gov Identifier: NCT04150029

Novartis Reference Number: CMBG453C12201

Last Update: Apr 26, 2022

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All compounds are either investigational or being studied for (a) new use(s). Efficacy and safety have not been established. There is no guarantee that they will become commercially available for the use(s) under investigation. 

Study Description

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.

Condition 
Acute Myeloid Leukemia
Phase 
Phase 2
Overall status 
Recruiting
Start date 
Sep 01, 2020
Completion date 
Mar 10, 2026
Gender 
All
Age(s)
18 Years and older (Adult, Older Adult)

Interventions

Drug
MBG453
Solution for intravenous infusion
Drug
Venetoclax
Tablet for oral administration
Drug
Azacitidine
Solution for subcutaneous injection or intravenous infusion

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 Locations

United States
25University of Alabama at Birmingham
Recruiting
Birmingham, 35294 - Alabama
Contact: (205-934-5059) Omer Jamy
United States
UCSF Medical Center
Recruiting
San Francisco, 94143 - California
Contact: Eseosa Igbinedion (415-353-1351) - [email protected] - Neil Dunavin
United States
Yale University School of Medicine
Recruiting
New Haven, 06520 - Connecticut
Contact: Victoria Lobo - [email protected] - Amer Zeidan
United States
University of Iowa Hospitals and Clinics Univ of Iowa Hosp & Clinic
Recruiting
Iowa City, 52242 - Iowa
Contact: (319-356-3425) Grerk Sutamtewagul
United States
Dana Farber Cancer Institute Dana Farber Cancer Int
Recruiting
Boston, 02215 - Massachusetts
Contact: (617-632-3352) Marlise Luskin
United States
Mayo Clinic Dept. of Mayo Clinic (2)
Recruiting
Rochester, 55905 - Minnesota
Contact: Rochelle Erickson (507-284-5689) - [email protected] - Aref Al-Kali
United States
Memorial Sloan Kettering Dept. of MSKCC
Recruiting
New York, 10017 - New York
Contact: Cary Saito (646-227-2157) - [email protected] - Eytan Stein
United States
Weill Cornell Medicine NewYork Presbyterian Hospital
Recruiting
New York, 10021 - New York
Contact: (646-962-2535) Gail J Roboz
United States
Duke University Medical Center
Recruiting
Durham, 27710 - North Carolina
Contact: Lynn Volk (919-684-8964) - [email protected] - Harry Erba
United States
Chattanooga Oncology and Hematology Associates PC Tennessee Oncology Chattanooga
Recruiting
Chattanooga, 37404 - Tennessee
Contact: Kara Huff (+1 423 698 1844) - [email protected] - Bertrand Marquess Anz
United States
MD Anderson Cancer Center/University of Texas MD Anderson
Recruiting
Houston, 77030 - Texas
Contact: Hannah Acres (713-792-7305) - [email protected] - Guillermo Garcia-Manero
United States
Huntsman Cancer Institute Univ of Utah
Recruiting
Salt Lake City, 84112 0550 - Utah
Contact: Maura Hughes (801-585-0236) - [email protected] - Tibor Kovacsovics
United States
Australia
Novartis Investigative Site
Recruiting
Clayton, 3168
Victoria
Australia
Canada
Novartis Investigative Site
Recruiting
Vancouver, V5Z 1M9
British Columbia
Canada
Novartis Investigative Site
Recruiting
Toronto, M5G 1Z6
Ontario
Canada
Novartis Investigative Site
Recruiting
Montreal, H3T 1E2
Quebec
Canada
France
Novartis Investigative Site
Recruiting
Paris Cedex 10, 75475
-
France
Novartis Investigative Site
Recruiting
Toulouse, 31059
-
France
Germany
Novartis Investigative Site
Recruiting
Berlin, 13353
-
Germany
Novartis Investigative Site
Recruiting
Leipzig, 04103
-
Germany
Italy
Novartis Investigative Site
Recruiting
Milano, 20162
MI
Italy
Novartis Investigative Site
Recruiting
Roma, 00133
RM
Italy
Japan
Novartis Investigative Site
Recruiting
Fukushima city, 960 1295
Fukushima
Japan
Novartis Investigative Site
Recruiting
Yamagata, 990 9585
-
Japan
Korea, Republic of
Novartis Investigative Site
Recruiting
Seoul, 06591
Seocho Gu
Korea, Republic of
Spain
Novartis Investigative Site
Recruiting
Barcelona, 08036
Catalunya
Spain
Novartis Investigative Site
Recruiting
Madrid, 28009
-
Spain
Taiwan
Novartis Investigative Site
Recruiting
Kaohsiung City, 83301
-
Taiwan
Novartis Investigative Site
Recruiting
Taoyuan, 33305
-
Taiwan

Contacts

Name: 
Novartis Pharmaceuticals
Phone: 
Name: 
Novartis Pharmaceuticals
Phone: 

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Call 1-888-669-6682 or email [email protected]