Study to Determine the Efficacy of Uproleselan (GMI-1271) in Combination With Chemotherapy to Treat Relapsed/Refractory Acute Myeloid Leukemia
- Registration Number
- NCT03616470
- Lead Sponsor
- GlycoMimetics Incorporated
- Brief Summary
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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 388
- ≥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
- 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
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Uproleselan (GMI-1271) Uproleselan Uproleselan in combination with mitoxantrone, etoposide and cytarabine (MEC) or fludarabine, cytarabine and idarubicin (FAI) Placebo (Saline, 0.9% Sodium Chloride) Placebo Placebo in combination with mitoxantrone, etoposide and cytarabine (MEC) or fludarabine, cytarabine and idarubicin (FAI)
- Primary Outcome Measures
Name Time Method Overall survival 5 years Time from the date of randomization into the study to the date of death.
- Secondary Outcome Measures
Name Time Method Overall response rate Up to 60 days Proportion of subjects who achieve a complete remission \[CR\] or CR with partial recovery \[CRh\] of blood counts
Rate of severe oral mucositis up to 60 days Incidence of severe oral mucositis experienced in patients after treatment.
Trial Locations
- Locations (70)
UC San Diego Moore Cancer Center
🇺🇸La Jolla, California, United States
University of California, Los Angeles - UCLA
🇺🇸Los Angeles, California, United States
University of California Irvine
🇺🇸Orange, California, United States
Stanford Cancer Institute
🇺🇸Palo Alto, California, United States
UC Davis Comprehensive Cancer Center
🇺🇸Sacramento, California, United States
Emory Winship Cancer Institute
🇺🇸Atlanta, Georgia, United States
Northside Hospital - Medical Tower
🇺🇸Atlanta, Georgia, United States
Rush University Medical Center
🇺🇸Chicago, Illinois, United States
The University of Kansas Cancer Center
🇺🇸Westwood, Kansas, United States
Dana Farber Cancer Institute
🇺🇸Boston, Massachusetts, United States
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