Study to Determine the Efficacy of Uproleselan (GMI-1271) in Combination With Chemotherapy to Treat Relapsed/Refractory Acute Myeloid Leukemia

• Status: Recruiting
• Trial end date: 2023-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: GlycoMimetics Incorporated

Criteria

Inclusion Criteria:

• ≥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

Exclusion Criteria:

• 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.