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Phase III Trial Evaluating Uproleselan (GMI-1271) for the Treatment of Adults With Relapsed/Refractory AML

Clinical Trial Details

Subjects will receive either uproleselan (GMI-1271) or placebo (saline solution) in a blinded fashion administered together with chemotherapy. Backbone induction chemotherapy will be the investigator's choice of either MEC or FAI; the decision will be made on a subject-by-subject basis prior to randomization. Randomized subjects will receive a sentinel dose of uproleselan or placebo 24 hours prior to the first dose of chemotherapy in each treatment cycle (induction and each of up to 3 consolidation cycles), then a dose every 12 hours throughout the chemotherapy treatment and for the 2 days following the last dose of chemotherapy. Each dose of uproleselan will be a fixed dose of 800 mg. Uproleselan or placebo will be administered IV at a steady rate over a period of 20 minutes (+/-2 minutes). Backbone induction chemotherapy will be given over 5 days. 

Key Eligibility: 

Men and women ages 18 through 75 years of age diagnosed with primary refractory AML or relapsed AML (first or second untreated relapse) and eligible to receive induction chemotherapy 

Study contact by location

Upper East Side - Manhattan

Contact(s)

Tania J. Curcio, NP, FNP-BC
(212) 746-2571
tjc9003@med.cornell.edu

Primary Investigator(s)

Protocol ID(s)

Weill Cornell Medicine IRB #:

1810019657

ClinicalTrials.gov:

NCT03616470

Sponsor:

GMI-1271-301

Status

Open to Enrollment

Age Group

Adult

Sponsor