Title: Study to Determine the Efficacy of Uproleselan (GMI-1271) in Combination With Chemotherapy to Treat Relapsed/Refractory Acute Myeloid Leukemia
Principal Investigator: Daniel J. DeAngelo, MD, PhD, Dana-Farber Cancer Institute
Description: Researchers are conducting a phase 3 trial comparing uproleselan plus chemotherapy with chemotherapy alone in patients with relapsed or refractory acute myeloid leukemia (AML).
In this randomized trial, patients in the chemotherapy-alone arm will receive placebo plus 1 of 2 chemotherapy regimens — mitoxantrone, etoposide, and cytarabine (MEC) or fludarabine, cytarabine, and idarubicin (FAI). Patients in the uproleselan arm will receive uproleselan in combination with MEC or FAI.
The primary endpoint is overall survival. Secondary endpoints include the rate of severe oral mucositis and overall response rate.
To be eligible for this study, patients must have a confirmed diagnosis of relapsed/refractory AML, be 18 to 75 years of age, and have no more than 1 prior stem cell transplant. For a complete list of eligibility criteria, please refer to the reference.
This study is sponsored by GlycoMimetics Incorporated.
Clinicaltrials.gov. Study to determine the efficacy of uproleselan (GMI-1271) in combination with chemotherapy to treat relapsed/refractory acute myeloid leukemia. NCT03616470. Accessed November 15, 2021.