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.
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Investigator(s)

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

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Contact

Amishi Jobanputra
650-723-8594

View on ClinicalTrials.gov