Studies to Assess Ziftomenib in Combination With Ven+Aza or 7+3 in Patients With Untreated NPM1-m or KMT2A-r AML (NCT07007312)
Phase 3 Randomized, Double-blind, Placebo-controlled Studies Assessing Ziftomenib in Combination With Either Standard of Care Nonintensive (Venetoclax+Azacitidine) or Intensive (7+3) Therapy in Patients With Untreated NPM1 Mutated or KMT2A Rearranged Acute Myeloid Leukemia
🩺 Plain-English Summary (8th-Grade Level)
Ziftomenib is an investigational drug in development for the treatment of patients with acute myeloid leukemia (AML) with eligible genetic alterations. Ziftomenib is a type of therapy known to target the menin pathway in cancer cells. This protocol has 2 separate studies that will investigate the benefits and risks of adding ziftomenib to standard-of-care (SOC) AML treatments in patients with certain genetic mutations who have not received any treatment for their AML. In the first study, the Nonintensive Therapy Study, older patients or those with serious medical problems will receive the SOC therapies venetoclax (ven) and azacitidine (aza), plus either ziftomenib or a placebo. In the second study, the Intensive Therapy Study, medically fit patients will receive (a) the SOC therapies cytarabine and daunorubicin, plus either ziftomenib or a placebo during a first treatment phase called induction, (b) cytarabine plus either ziftomenib or a placebo during a second treatment phase called consolidation, and (c) ziftomenib or a placebo during a third treatment phase called maintenance. The physician will determine which study is the appropriate treatment for the patient, but neither the patient nor their physician will know whether the patient has been assigned to receive ziftomenib or a placebo. This design is called "double-blinded".
Who can join: Review the eligibility criteria below.
Location: Banner MD Anderson Cancer Center — Gilbert, Arizona
Age range: 18 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (115 Sites)
Showing the first 25 of 115 sites.
- Banner MD Anderson Cancer Center — Gilbert, Arizona
- University of California, Fresno — Clovis, California
- University of California, San Diego — La Jolla, California
- Cedars-Sinai Medical Center — Los Angeles, California
- University of California, Los Angeles — Los Angeles, California
- University of California, Irvine — Orange, California
- University of Colorado — Aurora, Colorado
- Colorado Blood Cancer Institute — Denver, Colorado
- Hartford HealthCare Cancer Institute — Hartford, Connecticut
- Yale University School of Medicine — New Haven, Connecticut
- University of Miami — Miami, Florida
- Moffitt Cancer Center & Research Institute — Tampa, Florida
- University of Iowa — Iowa City, Iowa
- University of Kentucky — Lexington, Kentucky
- University of Massachusetts — Worcester, Massachusetts
- University of Michigan — Ann Arbor, Michigan
- Wayne State University School of Medicine — Detroit, Michigan
- University of Minnesota — Minneapolis, Minnesota
- Rutgers Biomedical and Health Sciences — New Brunswick, New Jersey
- University of New Mexico — Albuquerque, New Mexico
- State University of New York at Buffalo — Buffalo, New York
- Icahn School of Medicine at Mount Sinai — New York, New York
- Columbia University — New York, New York
- Weill Cornell Medical Center — New York, New York
- University of North Carolina, Chapel Hill — Chapel Hill, North Carolina
📞 Contact the Study Coordinator
Phone: 844-KURAONC (844-587-2662)
Email: medinfo@kuraoncology.com
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 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.
More studies in Acute Myeloid Leukemia (AML)
- A Study of Venetoclax in Combination With Azacitidine Versus Azacitidine in Treatment Naïve Participants With Acute Myeloid Leukemia Who Are Ineligible for Standard Induction Therapy — Duarte, California
- A Modified Dose of Rabbit Anti-thymocyte Globulin (rATG) in Children and Adults Receiving Treatment to Help Prepare Their Bodies for a Bone Marrow Transplant — New York, New York
- Venetoclax Added to Fludarabine + Busulfan Prior to Transplant and to Maintenance Therapy for AML, MDS, and MDS/MPN — Boston, Massachusetts
- A Study of Gilteritinib, Venetoclax and Azacitidine as a Combined Treatment for People Newly Diagnosed With Acute Myeloid Leukemia — Duarte, California
- Study of Oral LY3410738 in Patients With Advanced Hematologic Malignancies With IDH1 or IDH2 Mutations — Duarte, California
- Study of Monzosertib In Patients With R/R AML Or High-Risk Myelodysplastic Syndrome — Houston, Texas
Explore by condition: All Acute Myeloid Leukemia (AML) clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.