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NCT05146739 · ClinicalTrials.gov registry record · Phase 1

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

A Phase 1 study of Refractory Acute Myeloid Leukemia and Recurrent Acute Myeloid Leukemia, sponsored by National Cancer Institute (NCI).

Active
Registry status
Phase 1
Development phase
8
Enrollment target
19
Study locations

NCT05146739: Active Phase 1 study of Refractory Acute Myeloid Leukemia and Recurrent Acute Myeloid Leukemia, sponsored by National Cancer Institute (NCI).

NCT05146739 is a Phase 1 study of Refractory Acute Myeloid Leukemia and Recurrent Acute Myeloid Leukemia that is active but no longer recruiting, run by National Cancer Institute (NCI). The registered enrollment target is 8 participants, below the 47-participant average among 63 other Refractory Acute Myeloid Leukemia trials with a reported enrollment target (83% lower). The trial reports 19 study locations across 16 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT05146739, a Phase 1 study of Refractory Acute Myeloid Leukemia and Recurrent Acute Myeloid Leukemia, is active but no longer recruiting, sponsored by National Cancer Institute (NCI).

ACTIVE NOT RECRUITING
Registry status
Phase 1
Development phase
8 participants
Enrollment target
19
Study locations

Study 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.

Primary Outcome

The MTD/RP2D will be the maximum dose at which fewer than one-third of patients experience dose limiting toxicities.

Conditions Studied

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

Interventions

  • DRUG Fludarabine
  • DRUG Leucovorin
  • DRUG Cytarabine
  • DRUG Triple Intrathecal Chemotherapy
  • DRUG Uproleselan

Study Locations (19)

California

  • Children's Hospital Los Angeles - Los Angeles
  • Children's Hospital of Orange County - Orange
  • UCSF Medical Center-Mission Bay - San Francisco

Pennsylvania

  • Children's Hospital of Philadelphia - Philadelphia
  • Children's Hospital of Pittsburgh of UPMC - Pittsburgh

Alabama

  • Children's Hospital of Alabama - Birmingham

Colorado

  • Children's Hospital Colorado - Aurora

District of Columbia

  • Children's National Medical Center - Washington D.C.

Georgia

  • Children's Healthcare of Atlanta - Arthur M Blank Hospital - Atlanta

Illinois

  • Lurie Children's Hospital-Chicago - Chicago

Indiana

  • Riley Hospital for Children - Indianapolis

Trial Details

FieldValue
Enrollment Target 8 participants
Start Date 2023-10-10
Est. Completion 2026-05-09
Phase Phase 1
National Cancer Institute (NCI)

3,257 total trials

What the registry record for NCT05146739 still lists

NCT05146739 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 8 participants, a relatively small participant target, below the 47-participant average among 63 other Refractory Acute Myeloid Leukemia trials with a reported enrollment target (83% lower).

The record links to 9 conditions, with Refractory Acute Myeloid Leukemia appearing as the primary indexed condition, and to 5 interventions - of which Fludarabine is the first listed.

NCT05146739 lists 19 locations in 16 states (California, Pennsylvania, Alabama).

Frequently Asked Questions

What is clinical trial NCT05146739 about?

NCT05146739 is a clinical study titled "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". 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 r...

What is the current status of trial NCT05146739?

This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 8 participants. The study started on 2023-10-10. Estimated completion is 2026-05-09.

What conditions does trial NCT05146739 study?

This clinical trial studies the following conditions: Refractory Acute Myeloid Leukemia, Recurrent Acute Myeloid Leukemia, Recurrent Myelodysplastic Syndrome, Refractory Myelodysplastic Syndrome, Acute Myeloid Leukemia Post Cytotoxic Therapy.

What interventions are being tested in trial NCT05146739?

The interventions under investigation include: Fludarabine (DRUG), Leucovorin (DRUG), Cytarabine (DRUG), Triple Intrathecal Chemotherapy (DRUG), Uproleselan (DRUG).

Who is sponsoring clinical trial NCT05146739?

This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT05146739 being conducted?

This trial has 19 study locations across Alabama, California, Colorado, District of Columbia, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Learn More About Clinical Trials

Similar trials for Refractory Acute Myeloid Leukemia

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT05146739's enrollment target sits among peer trials

8 61st of 63 higher than 3 of 63 other Refractory Acute Myeloid Leukemia trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Refractory Acute Myeloid Leukemia trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Related registry views

Source: ClinicalTrials.gov NCT05146739, the US trial registry maintained by the National Library of Medicine. NCT05146739 (small enrollment · multi site footprint · active not recruiting) retrieved and formatted by PlainTrial, see methodology.