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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 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years
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 moreAwards & 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.
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.
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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
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have been diagnosed with Acute Promyelocytic Leukemia.I have had a stem cell transplant before.My kidney function is reduced.My leukemia is not caused by a transplant but may be due to a genetic mutation like RUNX1.I can understand and am willing to sign the consent form, or my guardian can.I had severe brain involvement but it's better now.My lung function is significantly reduced or I need extra oxygen.I am mostly able to carry out daily activities.I weigh at least 10 kilograms.I am receiving a bone marrow or stem cell transplant from a perfectly matched donor.My white blood cell count is very low due to treatment.I have previously been treated with uproleselan.My cancer is in early remission or newly diagnosed and didn't respond well to initial treatments.I am between 1 and 39 years old.My disease has come back multiple times.I currently have an infection that is not well-controlled.
Research Study Groups:
This trial has the following groups:- Group 1: Uproleselan with pre-transplant conditioning
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.