A Phase III Randomized, Double-Blind Trial to Evaluate the Efficacy of Uproleselan Administered withChemotherapy versus Chemotherapy Alone in Patients with Relapsed/Refractory Acute Myeloid Leukemia
Study of Uproleselan (GMI-1271) in Combination With Chemotherapy to Treat Relapsed/Refractory Acute Myeloid Leukemia
Sponsor: GlycoMimetics Incorporated
Enrolling: Male and Female Patients
IRB Number: AAAS8706
U.S. Govt. ID: NCT03616470
Contact: Research Nurse Navigator: 212-342-5162 / cancerclinicaltrials@cumc.columbia.edu
Additional Study Information: The purpose of this study is to: Test if the lifespan of study participants is increased when uproleselan is added to standard chemotherapy medicines compared to standard chemotherapy alone; test if the number of study participants achieving disease remission is increased when uproleselan is added to standard chemotherapy medicines compared to standard chemotherapy alone; measure the effect of uproleselan on oral mucositis when given with standard chemotherapy medicines compared to standard chemotherapy alone. Oral mucositis is a complication that leads to ulcers in the mouth that may result in pain and interfere with the ability to eat food and drink liquids; learn about the safety and tolerability of uproleselan when given with standard chemotherapy medicines compared to standard chemotherapy alone; and find out how much uproleselan is in the blood of study participants after being administered uproleselan. The study medication, uproleselan (GMI-1271), is experimental. That means the United States Food and Drug Administration (FDA) has not determined that it is safe and effective for any use, and has not approved it for use in humans.
This study is closed
Investigator
Joseph Jurcic, MD
Do You Qualify?
Are you between 18 and 75 years old? Yes No
Have you been diagnosed with Acute Myeloid Leukemia (AML)? Yes No
Have you ever received chemotherapy? Yes No
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For more information, please contact:
Research Nurse Navigator
cancerclinicaltrials@cumc.columbia.edu
212-342-5162