๐Ÿ›๏ธ Verified NIH Record โ€ข Updated 2026-05-07

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

Multicenter, Open-label, Randomized, Phase 2 Study of Venetoclax and Azacitidine Plus Cusatuzumab Versus Venetoclax and Azacitidine Alone in Newly Diagnosed AML Patients Who Are Not Candidates for Intensive Therapy

๐Ÿ”ต Active, Not Recruiting Phase2 ๐Ÿ’Š Investigational Drug / Biologic Sponsor: OncoVerity, Inc.

๐Ÿฉบ Plain-English Summary (8th-Grade Level)

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 join: Review the eligibility criteria below.

Location: Banner MD Anderson โ€” Gilbert, Arizona

Age range: 18 Years

๐Ÿงช Interventions in This Study

๐Ÿ“‹ "Do I Qualify?" โ€” 1-Minute Self Screener

Instant Checklist

Full eligibility criteria are available on the official NIH protocol. View the criteria โ†—

๐Ÿ“ All Participating Trial Locations (38 Sites)

Showing the first 25 of 38 sites.

  • Banner MD Anderson โ€” Gilbert, Arizona
  • City of Hope โ€” Duarte, California
  • University of California Los Angeles โ€” Los Angeles, California
  • University of Colorado Health - Anschutz Cancer Pavilion - Anschutz Medical Campus โ€” Aurora, Colorado
  • Yale School of Medicine โ€” New Haven, Connecticut
  • University of Miami - Sylvester Comprehensive Cancer Center - Miami โ€” Miami, Florida
  • AdventHealth Medical Group Blood & Marrow Transplant at Orlando โ€” Orlando, Florida
  • University of South Florida = Moffitt Cancer Center and Research Institute โ€” Tampa, Florida
  • The University of Iowa Hospitals & Clinics โ€” Iowa City, Iowa
  • University of Kentucky Chandler Medical Center โ€” Lexington, Kentucky
  • Norton Healthcare, Inc. โ€” Louisville, Kentucky
  • Hackensack University Medical Center โ€” Hackensack, New Jersey
  • Hofstra/Northwell Health โ€” Lake Success, New York
  • Cornell University โ€” New York, New York
  • University of Rochester Medical Center โ€” Rochester, New York
  • Wake Forest North Carolina โ€” Winston-Salem, North Carolina
  • Cleveland Clinic - Taussig Cancer Institute โ€” Cleveland, Ohio
  • Medical University of South Carolina โ€” Charleston, South Carolina
  • Fred Hutch Seattle Cancer Care Alliance โ€” Seattle, Washington
  • Medical College of Wisonsin โ€” Milwaukee, Wisconsin
  • Tom Baker Cancer Center-Alberta Health Services - University of Calgary โ€” Calgary, Alberta
  • Stollery Children's Hospital-Walter C Mackenzie Health Sciences Centre - University of Alberta โ€” Edmonton, Alberta
  • Vancouver General Hospital, Gordon and Leslie Diamond Health Care Centre โ€” Vancouver, British Columbia
  • University of Western Ontario โ€” London, Ontario
  • The Ottawa Hospital - General Campus โ€” Ottawa, Ontario

๐Ÿ“ž Contact the Study Coordinator

Phone: (877) 632-6789

Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.

๐Ÿ’ฐ 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 ยง 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.

๐Ÿ’ก How to Participate

  1. Check the checklist above to see if you may qualify.
  2. Contact the study coordinator using the phone/email above.
  3. Ask about the visit schedule, what is covered at no cost, and any travel support.
  4. Confirm with your own doctor before making a decision.
๐Ÿ›๏ธ View Official NIH Record โ†—