Summary

Eligibility
for people ages 18-75 (full criteria)
Location
at UC Davis UC Irvine UCLA UCSD
Dates
study started
completion around
Principal Investigator
by Gary Schiller (ucla)

Description

Summary

This study will evaluate the efficacy of uproleselan (GMI-1271), a specific E-selectin antagonist, in combination with chemotherapy to treat relapsed/refractory AML, compared to chemotherapy alone. The safety of uproleselan when given with chemotherapy will also be investigated in patients with relapsed/refractory AML

Official Title

A Phase III Randomized, Double-Blind Trial to Evaluate the Efficacy of Uproleselan Administered With Chemotherapy Versus Chemotherapy Alone in Patients With Relapsed/Refractory Acute Myeloid Leukemia

Keywords

Acute Myeloid Leukemia, AML, Relapsed AML, Refractory AML, Leukemia, Myeloid Leukemia, Leukemia, Myeloid, Acute, Uproleselan, Uproleselan (GMI-1271)

Eligibility

You can join if…

Open to people ages 18-75

  • ≥18 years and ≤75 years in age
  • Patients with relapsed or refractory AML
  • No more than one prior stem cell transplant
  • Has not received the chemotherapy regimen to be used for induction on this trial
  • Is considered medically eligible to receive the chemotherapy regimen to be used for induction on this trial

You CAN'T join if...

  • Patients with acute promyelocytic leukemia, acute leukemia of ambiguous lineage (biphenotypic leukemia), chronic myeloid leukemia with myeloid blast crisis, or secondary refractory AML.
  • Active signs or symptoms of CNS involvement by malignancy.
  • Stem cell transplantation ≤4 months prior to dosing.
  • Any immunotherapy or radiotherapy therapy within 28 days of dosing; any other experimental therapy or chemotherapy within 14 days of dosing.
  • Prior use of G-CSF, CM-CSF or plerixafor within 7 days of dosing.
  • Inadequate organ function.
  • Abnormal liver function.
  • Known active infection with hepatitis A, B, or C, or human immunodeficiency virus.
  • Moderate kidney dysfunction (glomerular filtration rate <45 mL/min).
  • Uncontrolled acute life-threatening bacterial, viral, or fungal infection.
  • Clinically significant cardiovascular disease.
  • Major surgery within 4 weeks of dosing.

Locations

  • UC San Diego Moore Cancer Center
    La Jolla California 92093 United States
  • University of California, Los Angeles - UCLA
    Los Angeles California 90095 United States
  • University of California Irvine
    Orange California 92868 United States
  • UC Davis Comprehensive Cancer Center
    Sacramento California 95817 United States
  • Stanford Cancer Institute
    Palo Alto California 94304 United States

Lead Scientist at University of California Health

  • Gary Schiller (ucla)
    Professor-in-Residence, Medicine. Authored (or co-authored) 155 research publications

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
GlycoMimetics Incorporated
ID
NCT03616470
Phase
Phase 3 research study
Study Type
Interventional
Participants
About 388 people participating
Last Updated