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

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

Condition

  • Acute Myeloid Leukemia

Eligibility

Eligible Ages
Between 18 Years and 75 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • ≥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

  • 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.

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Uproleselan (GMI-1271) 		Uproleselan in combination with mitoxantrone, etoposide and cytarabine (MEC) or fludarabine, cytarabine and idarubicin (FAI)
  • Drug: Uproleselan
    A rationally designed E-selectin antagonist used to inhibit binding of cells to E-selectin
Placebo Comparator
Placebo (Saline, 0.9% Sodium Chloride) 		Placebo in combination with mitoxantrone, etoposide and cytarabine (MEC) or fludarabine, cytarabine and idarubicin (FAI)
  • Drug: Placebo
    Saline, 0.9% Sodium Chloride

More Details

Status
Active, not recruiting
Sponsor
GlycoMimetics Incorporated

Study Contact