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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
91
E-selectin antagonist
induction chemotherapy
induction chemotherapy
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
Safety assessed by frequency, severity and relatedness of adverse events
Time frame: up to 44 days
Time versus plasma concentration profile of GMI-1271
Plasma concentration of GMI-1271
Time frame: up to 11 days
Overall response rate
Proportion of subjects who achieve a complete response (CR) or CR with incomplete blood count recovery (CRi) per local investigator assessment
Time frame: up to 12 months
Time to response
Time from date of first dose to first documentation of response
Time frame: up to 12 months
Duration of response
Time from date of first documented remission to the date of relapse or death from any cause, whichever occurs first
Time frame: up to 12 months
Event-free survival
Time from date of first dose to the date of treatment failure, relapse, or death from any cause, whichever occurs first
Time frame: up to 12 months
Overall survival
The probability of survival at 6 months (Phase 1) and 12 months (Phase 2), after the date of first dose of study drug
Time frame: up to 12 months
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induction chemotherapy
induction chemotherapy
Cleveland Clinic
Cleveland, Ohio, United States
University of Washington
Seattle, Washington, United States
Princess Alexandra Hospital
Brisbane, Australia
University Hospital Galway
Galway, Ireland