Status:
COMPLETED
Study to Determine Safety, Pharmacokinetics and Efficacy of GMI-1271 in Combination With Chemotherapy in AML
Lead Sponsor:
GlycoMimetics Incorporated
Conditions:
Leukemia, Myeloid, Acute
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
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.
Eligibility Criteria
Inclusion
- Inclusion criteria:
- 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
- Exclusion criteria:
- 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
Exclusion
Key Trial Info
Start Date :
March 1 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2018
Estimated Enrollment :
91 Patients enrolled
Trial Details
Trial ID
NCT02306291
Start Date
March 1 2015
End Date
May 1 2018
Last Update
May 17 2019
Active Locations (8)
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1
University of California, Davis Comprehensive Cancer Center
Sacramento, California, United States, 95817
2
Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02115
3
University of Michigan, Ann Arbor
Ann Arbor, Michigan, United States, 48109
4
University of Rochester
Rochester, New York, United States, 14642