Study to Determine Safety, Pharmacokinetics and Efficacy of GMI-1271 in Combination With Chemotherapy in AML
- Conditions
- Leukemia, Myeloid, Acute
- Interventions
- Registration Number
- NCT02306291
- Lead Sponsor
- GlycoMimetics Incorporated
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 91
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Arm A (Phase I) GMI-1271 GMI-1271 in combination with mitoxantrone, etoposide and cytarabine (MEC) in relapsed/refractory subjects 18 years and older Arm C (Phase II Arm B) GMI-1271 GMI-1271 in combination with cytarabine and idarubicin (7+3 regimen) in newly diagnosed subjects 60 years and older Arm B (Phase II Arm A) GMI-1271 GMI-1271 in combination with mitoxantrone, etoposide and cytarabine (MEC) in relapsed/refractory subjects 18 years and older Arm B (Phase II Arm A) Cytarabine GMI-1271 in combination with mitoxantrone, etoposide and cytarabine (MEC) in relapsed/refractory subjects 18 years and older Arm A (Phase I) Mitoxantrone GMI-1271 in combination with mitoxantrone, etoposide and cytarabine (MEC) in relapsed/refractory subjects 18 years and older Arm A (Phase I) Etoposide GMI-1271 in combination with mitoxantrone, etoposide and cytarabine (MEC) in relapsed/refractory subjects 18 years and older Arm B (Phase II Arm A) Etoposide GMI-1271 in combination with mitoxantrone, etoposide and cytarabine (MEC) in relapsed/refractory subjects 18 years and older Arm A (Phase I) Cytarabine GMI-1271 in combination with mitoxantrone, etoposide and cytarabine (MEC) in relapsed/refractory subjects 18 years and older Arm B (Phase II Arm A) Mitoxantrone GMI-1271 in combination with mitoxantrone, etoposide and cytarabine (MEC) in relapsed/refractory subjects 18 years and older Arm C (Phase II Arm B) Cytarabine GMI-1271 in combination with cytarabine and idarubicin (7+3 regimen) in newly diagnosed subjects 60 years and older Arm C (Phase II Arm B) Idarubicin GMI-1271 in combination with cytarabine and idarubicin (7+3 regimen) in newly diagnosed subjects 60 years and older
- Primary Outcome Measures
Name Time Method Safety assessed by frequency, severity and relatedness of adverse events up to 44 days
- Secondary Outcome Measures
Name Time Method Duration of response up to 12 months Time from date of first documented remission to the date of relapse or death from any cause, whichever occurs first
Event-free survival up to 12 months Time from date of first dose to the date of treatment failure, relapse, or death from any cause, whichever occurs first
Time versus plasma concentration profile of GMI-1271 up to 11 days Plasma concentration of GMI-1271
Overall response rate up to 12 months Proportion of subjects who achieve a complete response (CR) or CR with incomplete blood count recovery (CRi) per local investigator assessment
Overall survival up to 12 months The probability of survival at 6 months (Phase 1) and 12 months (Phase 2), after the date of first dose of study drug
Time to response up to 12 months Time from date of first dose to first documentation of response
Trial Locations
- Locations (8)
University of Michigan, Ann Arbor
🇺🇸Ann Arbor, Michigan, United States
Dana Farber Cancer Institute
🇺🇸Boston, Massachusetts, United States
University of California, Davis Comprehensive Cancer Center
🇺🇸Sacramento, California, United States
Princess Alexandra Hospital
🇦🇺Brisbane, Australia
Cleveland Clinic
🇺🇸Cleveland, Ohio, United States
University of Rochester
🇺🇸Rochester, New York, United States
University of Washington
🇺🇸Seattle, Washington, United States
University Hospital Galway
🇮🇪Galway, Ireland