A Study Comparing Venetoclax and Azacitidine Plus Cusatuzumab to Venetoclax and Azacitidine in Newly Diagnosed AML Ineligible for Intensive Therapy (NCT06384261)

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

1. Men and women ≥18 years old
2. Must sign an informed consent form (ICF) indicating that he or she understands the purpose of, and procedures required for the study and is willing to participate in the study
3. Diagnosis of AML according to ICC 2022 (with the exclusion of MDS/AML with 10-19% blasts)
4. Previously untreated AML except may have received emergency leukapheresis, hydroxyurea before study entry to control hyperleukocytosis
5. Deemed unfit for intensive chemotherapy by meeting at least 1 of the following criteria:
6. Participant is ≥75 years of age with Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2 OR
7. Participant is ≥18 to 74 years of age and has any of the following comorbidities:
8. ECOG performance status of 2 or 3
9. Cardiac status including any one of the following: congestive heart failure requiring treatment or ejection fraction ≤50% or chronic stable angina
10. Known history of diffusion capacity of lung for carbon monoxide (DLCO) ≤65% of forced expiratory volume in the first second (FEV1) ≤65%
11. Creatinine clearance (CrCl) ≥15 mL/min to \<45 mL/min
12. Hepatic disorder with total bilirubin \>1.5 to 3x the upper limit of normal (ULN)

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (38 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
• University of Miami - Sylvester Comprehensive Cancer Center - Miami — Miami, Florida
• AdventHealth Medical Group Blood &amp; Marrow Transplant at Orlando — Orlando, Florida
• University of South Florida = Moffitt Cancer Center and Research Institute — Tampa, Florida
• The University of Iowa Hospitals & Clinics — Iowa City, Iowa
• University of Kentucky Chandler Medical Center — Lexington, Kentucky
• Norton Healthcare, Inc. — Louisville, Kentucky
• Hackensack University Medical Center — Hackensack, New Jersey
• Hofstra/Northwell Health — Lake Success, New York
• Cornell University — New York, New York
• University of Rochester Medical Center — Rochester, New York
• Wake Forest North Carolina — Winston-Salem, North Carolina
• Cleveland Clinic - Taussig Cancer Institute — Cleveland, Ohio
• Medical University of South Carolina — Charleston, South Carolina
• Fred Hutch Seattle Cancer Care Alliance — Seattle, Washington
• Medical College of Wisonsin — Milwaukee, Wisconsin
• Tom Baker Cancer Center-Alberta Health Services - University of Calgary — Calgary, Alberta
• Stollery Children's Hospital-Walter C Mackenzie Health Sciences Centre - University of Alberta — Edmonton, Alberta
• Vancouver General Hospital, Gordon and Leslie Diamond Health Care Centre — Vancouver, British Columbia
• University of Western Ontario — London, Ontario
• The Ottawa Hospital - General Campus — Ottawa, Ontario

💰 Cost, Insurance & Patient Rights

• 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
• Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
• Voluntary Participation: You may withdraw at any time without affecting your standard medical care.