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E-selectin Inhibitor

Uproleselan for Acute Myeloid Leukemia

Phase 1 & 2
Recruiting
Led By John Horan
Research Sponsored by John Horan, MD
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Disease status: In a first or second complete remission with minimal residual disease after at least 2 cycles of induction/re-induction chemotherapy, or newly diagnosed disease or disease in first relapse that is refractory to at least 2 cycles of induction/re-induction chemotherapy.
Age ≥12 months and ≤ 39 years
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years
Awards & highlights

Study Summary

This trial is studying a new drug, uproleselan, to see if it can help leukemia patients.

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.Check my eligibility
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.See study design
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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My cancer is in early remission or newly diagnosed and didn't respond well to initial treatments.
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I am between 1 and 39 years old.
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I am mostly able to carry out daily activities.
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I weigh at least 10 kilograms.
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I am receiving a bone marrow or stem cell transplant from a perfectly matched donor.

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

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

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
2018
Completed Phase 2
~60
Fludarabine
2012
Completed Phase 3
~1100
Clofarabine
2007
Completed Phase 3
~1130
Busulfan
2008
Completed Phase 3
~1120

Find a Location

Who is running the clinical trial?

John Horan, MDLead Sponsor
GlycoMimetics IncorporatedIndustry Sponsor
22 Previous Clinical Trials
1,484 Total Patients Enrolled
John HoranPrincipal InvestigatorDana-Farber Cancer Institute

Media Library

Uproleselan (E-selectin Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT05569512 — Phase 1 & 2
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 & 2
Uproleselan (E-selectin Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05569512 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Who meets the inclusionary criteria for this trial?

"This study is looking for 28 participants between the ages of 12 months and 30 who have leukemia, myelocytic, acute. In order to be eligible, participants must also meet the following criteria: Have newly diagnosed disease or disease in first relapse that is refractory (defined as marrow with >1% leukemic blasts by MDF or persistence of extramedullary disease) to at least 2 cycles of induction/re-induction chemotherapy., This sample will be used for eligibility as well as correlative biomarkers. Please see section 9.2 for details regarding collection, processing, and shipping of the sample"

Answered by AI

Are subjects of this experiment restricted to those over the age of majority?

"The eligibility requirements for this study state that potential participants must fall between 12 months and 30 years old."

Answered by AI

Are we recruiting participants for this research right now?

"If you are interested in participating in this clinical trial, you may be eligible! This study was first posted on October 6th, 2020 and has since been updated."

Answered by AI

What are the main goals that this trial is hoping to achieve?

"The sponsor of this study, GlycoMimetics Incorporated, has reported that the primary outcome measure for this trial will be Dose Limiting Toxicity (DLT) Phase 2. This will be measured over a period of time spanning from Day -8 pre-transplant to post-transplant Day +30. In addition to the primary outcome, this study will also assess secondary outcomes including 12-month Leukemia-Free Survival (LFS), Uproleselan Pharmacokinetics, and Relapse Rate at the RP2D."

Answered by AI
~19 spots leftby Dec 2027