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

GlycoMimetics

Status and phase: Terminated; Phase 3

Conditions: Acute Myeloid Leukemia

Treatments: Drug: Uproleselan; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT03616470

GMI-1271-301

Details and patient eligibility

About

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

Enrollment: 388 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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388 participants in 2 patient groups, including a placebo group

Uproleselan (GMI-1271)

Experimental group

Description:

Uproleselan in combination with mitoxantrone, etoposide and cytarabine (MEC) or fludarabine, cytarabine and idarubicin (FAI)

Treatment:

Drug: Uproleselan

Placebo (Saline, 0.9% Sodium Chloride)

Placebo Comparator group

Description:

Placebo in combination with mitoxantrone, etoposide and cytarabine (MEC) or fludarabine, cytarabine and idarubicin (FAI)

Treatment:

Drug: Placebo