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

GMI-1271-301

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

2018-10-15

2024-06-01

2024-12-01

Active (not recruiting)

Early phase I

388

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.

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 388, 'type': 'ACTUAL'}}

2023-07-25