Study to Determine Safety, Pharmacokinetics and Efficacy of GMI-1271 in Combination With Chemotherapy in AML

Completed · Phase 1/Phase 2

Conditions studied: Leukemia, Myeloid, Acute

In brief

This study will evaluate GMI-1271, a specific E-selectin antagonist, in acute myeloid leukemia in combination with standard agents used to treat this disease.

Key facts

Study ID

NCT02306291

Run by

GlycoMimetics Incorporated

People needed

91

Starts

2015-03-01

Expected to finish

2018-05-01

Last updated by the study team

2019-05-17

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• AML (including secondary AML) diagnosed as per WHO criteria
• For relapsed/refractory subjects only:
• Subjects age ≥ 18 years with relapsed or refractory AML after ≤ 2 prior induction regimens, at least one containing anthracyclines
• Medically eligible to receive MEC
• Absolute blast count (ABC) ≤ 40,000/mm
• For treatment-naïve subjects only:
• Subjects ≥ 60 years of age with newly diagnosed AML
• Medically eligible to receive "7+3" cytarabine/idarubicin
• ABC count ≤ 40,000/mm
• ECOG performance status 0-2
• Hemodynamically stable and adequate organ function

You may not qualify if…

• Acute promyelocytic leukemia
• Acute leukemia of ambiguous lineage (biphenotypic leukemia)
• Active signs or symptoms of CNS involvement by malignancy
• No prior G-CSF, GM-CSF or plerixafor within 14 days of study drug dosing
• Known history or evidence of active hepatitis A, B, or C or HIV
• Uncontrolled acute life threatening bacterial, viral or fungal infection
• Active graft versus host disease (GVHD) ≥ Grade 2 or extensive chronic GVHD requiring immunosuppressive therapy
• Hematopoietic stem cell transplantation ≤ 4 months of dosing
• Clinically significant cardiovascular disease

Where it is running

• University of California, Davis Comprehensive Cancer Center — Sacramento, California, United States
• Dana Farber Cancer Institute — Boston, Massachusetts, United States
• University of Michigan, Ann Arbor — Ann Arbor, Michigan, United States
• University of Rochester — Rochester, New York, United States
• Cleveland Clinic — Cleveland, Ohio, United States
• University of Washington — Seattle, Washington, United States
• Princess Alexandra Hospital — Brisbane, Australia
• University Hospital Galway — Galway, Ireland

Full record on ClinicalTrials.gov

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