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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 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 8

Last updated 2026-05-05

Study results available
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Summary

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.

Conditions

  • Acute Myeloid Leukemia Post Cytotoxic Therapy
  • Myelodysplastic Syndrome Post Cytotoxic Therapy
  • Myeloid Leukemia Associated With Down Syndrome
  • Recurrent Acute Myeloid Leukemia
  • Recurrent Mixed Phenotype Acute Leukemia
  • Recurrent Myelodysplastic Syndrome
  • Refractory Acute Myeloid Leukemia
  • Refractory Mixed Phenotype Acute Leukemia
  • Refractory Myelodysplastic Syndrome

Interventions

DRUG

Cytarabine

Given IV and IT

DRUG

Fludarabine

Given IV

DRUG

Leucovorin

Give PO or IV

DRUG

Triple Intrathecal Chemotherapy

Given IT

DRUG

Uproleselan

Given IV

Sponsors & Collaborators

  • Children's Oncology Group

    collaborator NETWORK

  • LLS PedAL LLC

    collaborator UNKNOWN

  • National Cancer Institute (NCI)

    lead NIH

Principal Investigators

  • Maria Luisa Sulis · Pediatric Early Phase Clinical Trial Network

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-10-10
Primary Completion
2025-03-31
Completion
2026-05-09
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05146739 on ClinicalTrials.gov