GlycoMimetics:301 Phase3 GMI-1271 in subjects with RR AML - Clinical Trial

What is the Purpose of this Study?

We are doing this study to learn if the study drug uproleselan (GMI-1271) is helpful when given together with chemotherapy to patients with relapsed/refractory AML, compared to chemotherapy alone.

We also want to learn if uproleselan is safe when given with chemotherapy with patients that have relapsed/refractory AML

What is the Condition Being Studied?

Relapsed/Refractory Acute Myeloid Leukemia

Who Can Participate in the Study?

Adults who:
-Have either primary refractory or relapsed AML (first or second untreated relapse)

Age Group

What is Involved?

If you join the study, you will:
- Go through a screening process that includes having a bone marrow biopsy (removal of soft tissue in the bone) and aspirate, blood tests, physical exams, and other tests to determine eligibility for the study.
-Be randomized (like the flip of a coin) to receive chemotherapy with either uproleselan or placebo (saline). Neither you nor your study team or doctor will know what you are taking.
-Be hospitalized up to 60 days if you join main part of the study (depend on how long you need to be in the hospital for AML intervention your study doctor prescribes).
-Receive uproleselan or placebo (saline) directly into your vein (intravenously).
-Have blood tests to check your blood counts and kidney and liver function
-Have bone marrow exam, as needed to check your disease.
-Have heart scans (ECG) as needed
-After the End of Study Intervention visit be contacted every month for 2 years and every three months thereafter indefinitely for survival information.

Study Details

Full Title
A Phase III Randomized, Double-Blind Trial to Evaluate the Efficacy of Uproleselan Administered with Chemotherapy versus Chemotherapy Alone in Patients with Relapsed/Refractory Acute Myeloid Leukemia
Principal Investigator
Cell Therapy and Hematologic Malignancies Specialist
Protocol Number
IRB: PRO00100665
NCT: NCT03616470
Phase III
Enrollment Status
Open for Enrollment
Contact the Duke Recruitment Innovation Center