A Study of SNDX-5613 in Combination With Intensive Chemotherapy in Participants With Acute Myeloid Leukemias (NCT06226571)
A Phase 1, Open-label, Dose-escalation, and Dose-expansion Study to Evaluate Safety, Tolerability, and Clinical Activity of SNDX-5613 in Combination With Intensive Chemotherapy in Participants With Newly Diagnosed Acute Myeloid Leukemias Harboring Alterations in Lysine-specific Methyltransferase 2A (KMT2A/MLL), Nucleophosmin 1 (NPM1), and Nucleoporin 98 (NUP98) Genes
🩺 Plain-English Summary (8th-Grade Level)
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, and clinical activity of SNDX-5613 in combination with intensive chemotherapy in participants with newly diagnosed acute myeloid leukemia (AML) harboring alterations in KMT2A, NPM1, or NUP98 genes.
Who can join: Review the eligibility criteria below.
Location: City of Hope — Goodyear, Arizona
Age range: 18 Years to 75 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 (48 Sites)
Showing the first 25 of 48 sites.
- City of Hope — Goodyear, Arizona
- UCLA Medical Hematology — Burbank, California
- City of Hope Medical Center — Duarte, California
- AdventHealth Blood & Marrow Transplant Center — Orlando, Florida
- Tampa General Hospital — Tampa, Florida
- Emory Winship Cancer Institute — Atlanta, Georgia
- University of Illinois — Chicago, Illinois
- University of Chicago — Chicago, Illinois
- University of Louisville Health Brown Cancer Center — Louisville, Kentucky
- Norton Cancer Institute, St. Matthews Campus — Louisville, Kentucky
- Beth Israel Deaconess Medical Center — Boston, Massachusetts
- University of Michigan — Ann Arbor, Michigan
- Allina Health Cancer Institute — Minneapolis, Minnesota
- Washington University School of Medicine — St Louis, Missouri
- Institution name: Northwell Health-Brany — Lake Success, New York
- Memorial Sloan Kettering Cancer Center — New York, New York
- University of Rochester Medical Center — Rochester, New York
- SUNY Upstate Medical University — Syracuse, New York
- East Carolina University — Greenville, North Carolina
- Atrium Health Wake Forest Baptist Medical Center — Winston-Salem, North Carolina
- Cleveland Clinic Foundation — Cleveland, Ohio
- Oregon Health and Science University- Center for Hematologic Malignancies — Portland, Oregon
- UPMC Hillman Cancer Center — Pittsburgh, Pennsylvania
- MUSC Hollings Cancer Center (HCC) — Charleston, South Carolina
- Baylor University Medical Center — Dallas, Texas
📞 Contact the Study Coordinator
Phone: (800) 826-4673
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.
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💡 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.