Pharmacokinetics, Safety, and Efficacy of ASTX727 in Combination With Venetoclax in Acute Myeloid Leukemia (AML) (NCT04657081)
A Single-Arm, Open-Label Pharmacokinetic, Safety, and Efficacy Study of ASTX727 in Combination With Venetoclax in Adult Patients With Acute Myeloid Leukemia
🩺 Plain-English Summary (8th-Grade Level)
The Phase 1 portion of this study is a single-arm, open-label, multicenter, non-randomized interventional study to evaluate the pharmacokinetic (PK) interaction, safety, and efficacy of ASTX727 when given in combination with venetoclax for the treatment of newly diagnosed acute myeloid leukemia (AML) in adults who are age 75 years or older, or who have comorbidities that preclude use of intensive induction chemotherapy. The primary purpose of the study is to rule out drug-drug interactions between ASTX727 and venetoclax combination therapy by evaluating area under the curve (AUC) and maximum plasma concentration (Cmax) exposure. The Phase 2 portion of the study is to assess the efficacy of ASTX727 and venetoclax when given in combination and to evaluate potential PK interactions. Phase 2 will follow the same overall study design as Phase 1 and has two parts, Part A and Part B.
Who can join: Review the eligibility criteria below.
Location: USC Norris Comprehensive Cancer Center — Los Angeles, California
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 (34 Sites)
Showing the first 25 of 34 sites.
- USC Norris Comprehensive Cancer Center — Los Angeles, California
- Stanford University — Palo Alto, California
- Yale University — New Haven, Connecticut
- Baptist MD Anderson Cancer Center — Jacksonville, Florida
- Boca Raton Clinical Research — Plantation, Florida
- The University of Chicago Medical Center — Chicago, Illinois
- Indiana University Simon Cancer Center — Indianapolis, Indiana
- Tufts Medical Center — Boston, Massachusetts
- Massachusetts General Hospital — Boston, Massachusetts
- University of Massachusetts, Memorial Medical Center — Worcester, Massachusetts
- Health Midwest Ventures Group, Inc. — Kansas City, Missouri
- Hackensack University of Medical Center — Hackensack, New Jersey
- Roswell Park Comprehensive Cancer Center — Buffalo, New York
- Weill Cornell Medical College — New York, New York
- University of Rochester — Rochester, New York
- The Research Foundation of the State University of New York (SUNY) — Syracuse, New York
- East Carolina University — Greenville, North Carolina
- The Ohio State University — Columbus, Ohio
- Penn State Milton S. Hershey Medical Center — Hershey, Pennsylvania
- UPMC Hillman Cancer Center — Pittsburgh, Pennsylvania
- Vanderbilt University Medical Center — Nashville, Tennessee
- MD Anderson Cancer Center — Houston, Texas
- Baylor Scott & White Research Institute — Temple, Texas
- Seattle Cancer Care Alliance — Seattle, Washington
- University of Calgary - Health Sciences Centre — Calgary, Alberta
💰 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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Explore by condition: All Acute Myeloid Leukemia clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Review the official NIH record below to find the coordinating site.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.