A Study Comparing Venetoclax and Azacitidine Plus Cusatuzumab to Venetoclax and Azacitidine in Newly Diagnosed AML Ineligible for Intensive Therapy

Part of paid clinical trials in Gilbert, Arizona.

Sponsor
OncoVerity, Inc.
Study ID
NCT06384261
Phase
PHASE2
Status
Active Not Recruiting

Conditions

  • Leukemia, Myeloid, Acute

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Cusatuzumab — DRUG
    CD70 monoclonal antibody
  • Venetoclax — DRUG
    BCL-2 inhibitor
  • Azacitidine — DRUG
    Hypomethylating agent

Study Details

The goal of this clinical trial is to learn if participants treated with the experimental drug cusatuzumab added to venetoclax and azacitidine works to treat acute myeloid leukemia (AML) compared to venetoclax and azacitidine. Venetoclax and azacitidine are drugs commonly used to treat AML in patients that are unable to receive chemotherapy to treat AML. The main question the clinical trial aims to answer is does cusatuzumab added to venetoclax and azacitidine prolong the length of time participants live compared to venetoclax and azacitidine?

Key Dates

Start date
Jul 22, 2024
Status verified
May 2026
Primary completion
Jan 31, 2027
Completion
Jun 30, 2027

Study Design

Enrollment
140 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Part A: Cusatuzumab in combination with venetoclax and azacitidine
    Cusatuzumab 20 mg/kg administered intravenously on days 3 and 17 in combination with venetoclax administered orally up to 400 mg once daily and azacitidine 75 mg/m\^2 administered subcutaneously or intravenously once daily for 7 days of a 28 day cycle
  • Active Comparator: Part A: Venetoclax in combination with azacitidine
    Venetoclax administered orally up to 400 mg once daily and azacitidine 75 mg/m\^2 administered subcutaneously or intravenously once daily for 7 days of a 28 day cycle
  • Experimental: Part B: Cusatuzumab in combination with venetoclax and azacitidine
    Cusatuzumab 10 mg/kg administered intravenously on days 3 and 17 for cycle 1 and cycle 2 and 20 mg/kg intravenously on days 3 and 17 for cycle 3 and beyond in combination with venetoclax administered orally up to 400 mg once daily and azacitidine 75 mg/m\^2 administered subcutaneously or intravenously once daily for 7 days of a 28 day cycle

Primary Outcome Measure

Overall survival [ Time Frame: From date of randomization until the date of death from any cause, assessed up to 5 years ]

Locations (20)

FacilityCityStateZIPSite coordinators
Banner MD AndersonGilbertArizona85234-
City of HopeDuarteCalifornia91010-
University of California Los AngelesLos AngelesCalifornia90095-
University of Colorado Health - Anschutz Cancer Pavilion - Anschutz Medical CampusAuroraColorado80045-
Yale School of MedicineNew HavenConnecticut06510-
University of Miami - Sylvester Comprehensive Cancer Center - MiamiMiamiFlorida33136-
AdventHealth Medical Group Blood & Marrow Transplant at OrlandoOrlandoFlorida32804-
University of South Florida = Moffitt Cancer Center and Research InstituteTampaFlorida33612-
The University of Iowa Hospitals & ClinicsIowa CityIowa52242-
University of Kentucky Chandler Medical CenterLexingtonKentucky40536-
Norton Healthcare, Inc.LouisvilleKentucky40202-
Hackensack University Medical CenterHackensackNew Jersey07601-
Hofstra/Northwell HealthLake SuccessNew York11042-
Cornell UniversityNew YorkNew York10065-
University of Rochester Medical CenterRochesterNew York14642-
Wake Forest North CarolinaWinston-SalemNorth Carolina27157-
Cleveland Clinic - Taussig Cancer InstituteClevelandOhio44195-
Medical University of South CarolinaCharlestonSouth Carolina29425-
Fred Hutch Seattle Cancer Care AllianceSeattleWashington98109-
Medical College of WisonsinMilwaukeeWisconsin53226-

Find similar trials in Gilbert, AZ

By research site
Banner MD Anderson· Gilbert, AZCity of Hope· Duarte, CAUniversity of California Los Angeles· Los Angeles, CAUniversity of Colorado Health - Anschutz Cancer Pavilion - Anschutz Medical Campus· Aurora, COYale School of Medicine· New Haven, CTUniversity of Miami - Sylvester Comprehensive Cancer Center - Miami· Miami, FL

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