Active — Not RecruitingPhase 2

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

United States140 participantsStarted 2024-07-22

Plain-language summary

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?

Who can participate

Age range18 Years

SexALL

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Exclusion criteria

✕. Participant is ≥75 years of age with Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2 OR
✕. Participant is ≥18 to 74 years of age and has any of the following comorbidities:
✕. ECOG performance status of 2 or 3
✕. Cardiac status including any one of the following: congestive heart failure requiring treatment or ejection fraction ≤50% or chronic stable angina
✕. Known history of diffusion capacity of lung for carbon monoxide (DLCO) ≤65% of forced expiratory volume in the first second (FEV1) ≤65%
✕. Creatinine clearance (CrCl) ≥15 mL/min to \<45 mL/min
✕. Hepatic disorder with total bilirubin \>1.5 to 3x the upper limit of normal (ULN)
✕. Any other comorbidity that the investigators determine to be incompatible with conventional intensive chemotherapy

What they're measuring

Overall survival

Timeframe: From date of randomization until the date of death from any cause, assessed up to 5 years

Trial details

NCT IDNCT06384261

SponsorOncoVerity, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2027-01

View on ClinicalTrials.gov More Leukemia, Myeloid, Acute trials