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E-selectin Inhibitor

Uproleselan for Acute Myeloid Leukemia

Phase 1
Waitlist Available
Led By John Horan
Research Sponsored by Malika Kapadia
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing a new drug called uproleselan to see if it can help children with acute myeloid leukemia (AML) by making their cancer cells more sensitive to chemotherapy. The goal is to reduce relapse rates and improve survival after a stem cell transplant.

Who is the study for?
This trial is for pediatric AML patients aged 1 month to 30 years who have either newly diagnosed disease, are in first relapse, or have refractory disease after at least two chemotherapy cycles. They must be in remission with minimal residual disease and weigh over 10 kg. Participants need a compatible stem cell donor but can't join if they've had multiple relapses, certain organ dysfunctions, active infections including hepatitis B/C or HIV complications, previous stem cell transplants, Down Syndrome, or are pregnant/breastfeeding.
What is being tested?
The study tests uproleselan's safety and effectiveness when combined with pre-transplant conditioning drugs (busulfan, clofarabine, fludarabine) to reduce leukemia relapse and improve survival without leukemia post-stem cell transplant in children and young adults with AML.
What are the potential side effects?
Potential side effects of uproleselan may include reactions at the infusion site as well as general drug-related risks like nausea, vomiting, diarrhea. The conditioning drugs can cause mouth sores, low blood counts increasing infection risk; busulfan might also lead to liver issues.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Dose Limiting Toxicity (DLT) Phase 1
Dose Limiting Toxicity (DLT) Phase 2
Recommend Phase 2 Dose
Secondary study objectives
Leukemia
Number of Patients with Severe Oral or Gastrointestinal Mucositis
Overall Survival (OS)
+2 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Uproleselan with pre-transplant conditioningExperimental Treatment4 Interventions
Participants will receive IV uproleselan on day -8 prior to stem cell transplant. Uproleselan will be administered IV twice daily from day -7 through day -2. Participants will also receive a standard pre-transplant conditioning regimen with fludarabine, clofarabine and busulfan. Each of these 3 drugs will be administered IV once daily from day -7 through day -4.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Uproleselan
2021
Completed Phase 2
~100
Clofarabine
2007
Completed Phase 3
~1130
Fludarabine
2012
Completed Phase 4
~1860
Busulfan
2008
Completed Phase 4
~1710

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for Acute Myeloid Leukemia (AML) include intensive combination chemotherapy, which works by killing rapidly dividing cancer cells but also causes significant side effects like cytopenias and infections. Lower intensity treatments aim to reduce symptoms and prolong survival but are less likely to achieve long-term disease control. Specific agents like clofarabine and gilteritinib target particular pathways or mutations in AML cells, offering more tailored approaches. E-selectin inhibition, as seen with uproleselan, disrupts the adhesion of AML cells to the vascular niche, reducing chemoresistance and potentially improving treatment outcomes. Understanding these mechanisms helps tailor treatment plans to individual patient needs, improving efficacy and managing side effects.
Epigenetic deregulation in myeloid malignancies.Endothelial E-selectin inhibition improves acute myeloid leukaemia therapy by disrupting vascular niche-mediated chemoresistance.Progress in the problem of relapsed or refractory acute myeloid leukemia.

Find a Location

Who is running the clinical trial?

Malika KapadiaLead Sponsor
John Horan, MDLead Sponsor
GlycoMimetics IncorporatedIndustry Sponsor
22 Previous Clinical Trials
1,475 Total Patients Enrolled

Media Library

Uproleselan (E-selectin Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT05569512 — Phase 1
Acute Myeloid Leukemia Research Study Groups: Uproleselan with pre-transplant conditioning
Acute Myeloid Leukemia Clinical Trial 2023: Uproleselan Highlights & Side Effects. Trial Name: NCT05569512 — Phase 1
Uproleselan (E-selectin Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05569512 — Phase 1
~0 spots leftby Dec 2025