Highest Dose of Uproleselan in Combination With Fludarabine and Cytarabine for Patients With Acute Myeloid Leukemia, Myelodysplastic Syndrome, or Mixed Phenotype Acute Leukemia Relapsed or Refractory That Expresses E-selectin Ligand on the Cell Membrane (NCT05146739)
A Phase 1 and Pharmacokinetic Study of Uproleselan (GMI-1271, NSC #801708) in Combination With Fludarabine and Cytarabine for Patients With Acute Myeloid Leukemia, Myelodysplastic Syndrome or Mixed Phenotype Acute Leukemia That Expresses E-selectin Ligand on the Cell Membrane and is in Second or Greater Relapse or That is Refractory to Relapse Therapy
🩺 Plain-English Summary (8th-Grade Level)
This phase I trial tests the safety, side effects, and determination of the best dose of uproleselan in combination with fludarabine and cytarabine in treating patients with acute myeloid leukemia, myelodysplastic syndrome or mixed phenotype acute leukemia that has come back (relapsed) or does not respond to treatment (refractory) and that expresses E-selectin ligand on the cell membrane. Uproleselan binds to E-selectin expressed on endothelial cells of the bone marrow and prevents their interaction with selectin-E ligand-expressing cancer cells. This may prevent leukemia cells from being sequestered in the bone marrow niche and escaping the effect of chemotherapy. Chemotherapy drugs, such as fludarabine and cytarabine, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving uproleselan in combination with fludarabine and cytarabine may expose more cancer cells to the effect of chemotherapy.
Who can join: Review the eligibility criteria below.
Location: Children's Hospital of Alabama — Birmingham, Alabama
Age range: Not specified to 17 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 (19 Sites)
- Children's Hospital of Alabama — Birmingham, Alabama
- Children's Hospital Los Angeles — Los Angeles, California
- Children's Hospital of Orange County — Orange, California
- UCSF Medical Center-Mission Bay — San Francisco, California
- Children's Hospital Colorado — Aurora, Colorado
- Children's National Medical Center — Washington D.C., District of Columbia
- Children's Healthcare of Atlanta - Arthur M Blank Hospital — Atlanta, Georgia
- Lurie Children's Hospital-Chicago — Chicago, Illinois
- Riley Hospital for Children — Indianapolis, Indiana
- C S Mott Children's Hospital — Ann Arbor, Michigan
- University of Minnesota/Masonic Cancer Center — Minneapolis, Minnesota
- Washington University School of Medicine — St Louis, Missouri
- Memorial Sloan Kettering Cancer Center — New York, New York
- Cincinnati Children's Hospital Medical Center — Cincinnati, Ohio
- Children's Hospital of Philadelphia — Philadelphia, Pennsylvania
- Children's Hospital of Pittsburgh of UPMC — Pittsburgh, Pennsylvania
- Saint Jude Children's Research Hospital — Memphis, Tennessee
- Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center — Houston, Texas
- Seattle Children's Hospital — Seattle, Washington
💰 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.
- 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.