Study to Determine the Efficacy of Uproleselan (GMI-1271) in Combination With Chemotherapy to Treat Relapsed / Refractory Acute Myeloid Leukemia
Trial Status: Active
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
- ≥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.
UCLA / Jonsson Comprehensive Cancer Center
Contact: Bruck Habtemariam
Stanford Cancer Institute Palo Alto
University of California Davis Comprehensive Cancer Center
University of California San Diego
Emory University Hospital / Winship Cancer Institute
University of Kansas Cancer Center
Brigham and Women's Hospital
Dana-Farber Cancer Institute
Wayne State University / Karmanos Cancer Institute
Siteman Cancer Center at Washington University
Roswell Park Cancer Institute
Memorial Sloan Kettering Cancer Center
Contact: Martin S. Tallman
Duke University Medical Center
Wake Forest University Health Sciences
Case Comprehensive Cancer Center
Ohio State University Comprehensive Cancer Center
M D Anderson Cancer Center
Salt Lake City
Huntsman Cancer Institute / University of Utah
Fred Hutch / University of Washington Cancer Consortium
Trial Phase Phase III
Trial Type Treatment
- Primary ID GMI-1271-301
- Secondary IDs NCI-2018-02198
- Clinicaltrials.gov ID NCT03616470