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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

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

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.