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

PHASE1Active, not recruitingINTERVENTIONAL
Enrollment

8

Participants

Timeline

Start Date

October 10, 2023

Primary Completion Date

March 31, 2025

Study Completion Date

May 9, 2026

Conditions
Acute Myeloid Leukemia Post Cytotoxic TherapyMyelodysplastic Syndrome Post Cytotoxic TherapyMyeloid Leukemia Associated With Down SyndromeRecurrent Acute Myeloid LeukemiaRecurrent Mixed Phenotype Acute LeukemiaRecurrent Myelodysplastic SyndromeRefractory Acute Myeloid LeukemiaRefractory Mixed Phenotype Acute LeukemiaRefractory 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

Trial Locations (19)

10065

Memorial Sloan Kettering Cancer Center, New York

15224

Children's Hospital of Pittsburgh of UPMC, Pittsburgh

19104

Children's Hospital of Philadelphia, Philadelphia

20010

Children's National Medical Center, Washington D.C.

30329

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

35233

Children's Hospital of Alabama, Birmingham

38105

Saint Jude Children's Research Hospital, Memphis

45229

Cincinnati Children's Hospital Medical Center, Cincinnati

46202

Riley Hospital for Children, Indianapolis

48109

C S Mott Children's Hospital, Ann Arbor

55455

University of Minnesota/Masonic Cancer Center, Minneapolis

60611

Lurie Children's Hospital-Chicago, Chicago

63110

Washington University School of Medicine, St Louis

77030

Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center, Houston

80045

Children's Hospital Colorado, Aurora

90027

Children's Hospital Los Angeles, Los Angeles

92868

Children's Hospital of Orange County, Orange

94158

UCSF Medical Center-Mission Bay, San Francisco

98105

Seattle Children's Hospital, Seattle

All Listed Sponsors
collaborator

Children's Oncology Group

NETWORK

collaborator

LLS PedAL LLC

UNKNOWN

lead

National Cancer Institute (NCI)

NIH

NCT05146739 - 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 | Biotech Hunter | Biotech Hunter