Summary

for people ages 18-75 (full criteria)
at Sacramento, California and other locations
study started
estimated completion
Brian Jonas, MD

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 Leukemia, Myeloid 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 Davis Comprehensive Cancer Center accepting new patients
    Sacramento California 95817 United States
  • UC San Diego Moore Cancer Center accepting new patients
    La Jolla California 92093 United States

Lead Scientist

  • Brian Jonas, MD
    Assistant Professor, Hematology and Oncology. Authored (or co-authored) 18 research publications

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
GlycoMimetics Incorporated
Links
Sign up for this study
ID
NCT03616470
Phase
Phase 3
Study Type
Interventional
Last Updated