OncoMatch/Clinical Trials/NCT06384261
A Study Comparing Venetoclax and Azacitidine Plus Cusatuzumab to Venetoclax and Azacitidine in Newly Diagnosed AML Ineligible for Intensive Therapy
Is NCT06384261 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including Cusatuzumab and Venetoclax for leukemia, myeloid, acute.
Treatment: Cusatuzumab · Venetoclax · Azacitidine — 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?
Check if I qualifyExtracted eligibility criteria
Cancer type
Acute Myeloid Leukemia
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Cannot have received: hypomethylating agent
Participant has received a hypomethylating agent (HMA) or venetoclax for MDS or myeloproliferative neoplasm
Cannot have received: BCL2 inhibitor (venetoclax)
Participant has received a hypomethylating agent (HMA) or venetoclax for MDS or myeloproliferative neoplasm
Cannot have received: hematopoietic stem cell transplant
History of prior HSCT (allogeneic or autologous transplants)
Lab requirements
Kidney function
eGFR ≥30 mL/min/1.73 m2 (by MDRD formula). Participants <75 years may have eGFR ≥15 mL/min/1.73 m2. Creatinine clearance (CrCl) ≥15 mL/min to <45 mL/min (comorbidity criterion).
Liver function
AST and ALT <3xULN; for participants with leukemic infiltration of the liver, AST and ALT <5xULN is permitted. Total bilirubin ≤1.5xULN, unless bilirubin rise is due to Gilbert's syndrome or of nonhepatic origin. Participants <75 years may have bilirubin up to 3xULN.
Cardiac function
Cardiac status including any one of: congestive heart failure requiring treatment or ejection fraction ≤50% or chronic stable angina. Congestive heart failure severity that is NYHA Class III or IV [excluded]. Unstable angina [excluded].
Adequate liver and renal function defined as: AST and ALT <3xULN; for participants with leukemic infiltration of the liver, AST and ALT <5xULN is permitted. Total bilirubin ≤1.5xULN, unless bilirubin rise is due to Gilbert's syndrome or of nonhepatic origin. Participants <75 years may have bilirubin up to 3xULN. eGFR ≥30 mL/min/1.73 m2 (by MDRD formula). Participants <75 years may have eGFR ≥15 mL/min/1.73 m2.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Banner MD Anderson · Gilbert, Arizona
- City of Hope · Duarte, California
- University of California Los Angeles · Los Angeles, California
- University of Colorado Health - Anschutz Cancer Pavilion - Anschutz Medical Campus · Aurora, Colorado
- Yale School of Medicine · New Haven, Connecticut
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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