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

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
Novartis Pharmaceuticals
Study ID
NCT04150029
Phase
PHASE2
Status
Terminated

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 100 Years
Healthy Volunteers
Not accepted

Interventions

  • MBG453 — DRUG
    Solution for intravenous infusion
  • Venetoclax — DRUG
    Tablet for oral administration
  • Azacitidine — DRUG
    Solution for subcutaneous injection or intravenous infusion

Study Details

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 Dates

Start date
Sep 1, 2020
Status verified
Dec 2025
Primary completion
Oct 25, 2024
Completion
Oct 25, 2024

Study Design

Enrollment
90 participants (actual)
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: MBG453+Venetoclax +Azacitidine
    Participants received MBG453 in combination with Venetoclax and Azacitidine

Primary Outcome Measure

Incidence of Dose Limiting Toxicities (DLT)(Safety run-in Patients Only) [ Time Frame: From Cycle 1 Day 8 to end of Cycle 2; Cycle =28 Days ]

Locations (12)

FacilityCityStateZIPSite coordinators
25Uni of Alabama at BirminghamBirminghamAlabama35294-
Yale University School Of MedicineNew HavenConnecticut06520-
Uni Of Iowa Hospitals And ClinicsIowa CityIowa52242-
Dana Farber Cancer InstituteBostonMassachusetts02215-
Mayo Clinic RochesterRochesterMinnesota55905-
Memorial Sloan KetteringNew YorkNew York10017-
Weill Cornell Medicine NY-PresbNew YorkNew York10021-
Levine Cancer Insitute Carolinas Healthcare SystemCharlotteNorth Carolina28204-
Duke Univ Medical CenterDurhamNorth Carolina27710-
Chattanooga Onc And Hem Assoc PCChattanoogaTennessee37404-
MD Anderson Cancer Center University of TexasHoustonTexas77030-
Huntsman Cancer Institute Univ of UtahSalt Lake CityUtah84112 0550-

Find similar trials in Birmingham, AL

By condition
Leukemia (other)
By specialty
OncologyBlood cancer
By research site
25Uni of Alabama at Birmingham· Birmingham, ALYale University School Of Medicine· New Haven, CTUni Of Iowa Hospitals And Clinics· Iowa City, IADana Farber Cancer Institute· Boston, MAMayo Clinic Rochester· Rochester, MNMemorial Sloan Kettering· New York, NY

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