Uproleselan with pre-transplant conditioning for Acute Myeloid Leukemia

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Acute Myeloid Leukemia+1 MoreFludarabine - Drug
Eligibility
12 - 30
All Sexes
What conditions do you have?
Select

Study Summary

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

Eligible Conditions
  • Acute Myeloid Leukemia
  • Pediatric Cancer

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

3 Primary · 5 Secondary · Reporting Duration: Up to 2 years

12 months
Leukemia
Day 14
Number of Patients with Severe Oral or Gastrointestinal Mucositis
Year 2
Overall Survival (OS)
Day -8 pre- transplant through post-transplant Day +30
Recommend Phase 2 Dose
Day -8 pre-transplant to day -4 pre- transplant
Uproleselan Pharmacokinetics
Day 0
Dose Limiting Toxicity (DLT) Phase 1
Dose Limiting Toxicity (DLT) Phase 2
Up to 2 years
Relapse Rate at the RP2D

Trial Safety

Safety Progress

1 of 3

Trial Design

1 Treatment Group

Uproleselan with pre-transplant conditioning
1 of 1

Experimental Treatment

28 Total Participants · 1 Treatment Group

Primary Treatment: Uproleselan with pre-transplant conditioning · No Placebo Group · Phase 1 & 2

Uproleselan with pre-transplant conditioningExperimental Group · 4 Interventions: Fludarabine, Uproleselan, Clofarabine, Busulfan · Intervention Types: Drug, Drug, Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Fludarabine
2012
Completed Phase 3
~1170
Uproleselan
2018
Completed Phase 2
~60
Clofarabine
2007
Completed Phase 3
~1160
Busulfan
2008
Completed Phase 3
~1110

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: up to 2 years

Who is running the clinical trial?

John Horan, MDLead Sponsor
GlycoMimetics IncorporatedIndustry Sponsor
22 Previous Clinical Trials
1,493 Total Patients Enrolled
John HoranPrincipal InvestigatorDana-Farber Cancer Institute

Eligibility Criteria

Age 12 - 30 · All Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have a 70% or higher Lansky/Karnofsky performance status.
You have myelodysplastic syndrome.
You have a predisposition to leukemia or marrow failure syndrome other than those associated with transplant-related morbidity and mortality