Study to Determine the Efficacy of Uproleselan (GMI-1271) in Combination With Chemotherapy to Treat Relapsed/Refractory Acute Myeloid Leukemia

Trial ID or NCT#

NCT03616470

Status

not recruiting iconNOT RECRUITING

Purpose

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

Eligibility Criteria

Ages Eligible for Study: 18 Years to 75 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Inclusion Criteria:
  1. - ≥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
Exclusion Criteria:
  1. - 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.
View All Criteria
Show Less

Investigator(s)

Gabriel Mannis
Gabriel Mannis
Hematologist-Oncologist
Associate Professor of Medicine (Hematology)

Contact us to find out if this trial is right for you.

Contact

Amishi Jobanputra
650-723-8594

View on ClinicalTrials.gov