Clinical Trials /

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

NCT03616470

Description:

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

Related Conditions:
  • Acute Myeloid Leukemia
Recruiting Status:

Recruiting

Phase:

Phase 3

Trial Eligibility

Document

Title

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

Clinical Trial IDs

  • ORG STUDY ID: GMI-1271-301
  • NCT ID: NCT03616470

Conditions

  • Acute Myeloid Leukemia

Interventions

DrugSynonymsArms
UproleselanUproleselan (GMI-1271)
PlaceboPlacebo (Saline, 0.9% Sodium Chloride)

Purpose

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

Trial Arms

NameTypeDescriptionInterventions
Uproleselan (GMI-1271)ExperimentalUproleselan in combination with mitoxantrone, etoposide and cytarabine (MEC) or fludarabine, cytarabine and idarubicin (FAI)
  • Uproleselan
Placebo (Saline, 0.9% Sodium Chloride)Placebo ComparatorPlacebo in combination with mitoxantrone, etoposide and cytarabine (MEC) or fludarabine, cytarabine and idarubicin (FAI)
  • Placebo

Eligibility 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.
      
Maximum Eligible Age:75 Years
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Overall survival
Time Frame:5 years
Safety Issue:
Description:Time from the date of randomization into the study to the date of death.

Secondary Outcome Measures

Measure:Rate of severe oral mucositis
Time Frame:up to 60 days
Safety Issue:
Description:Incidence of severe oral mucositis experienced in patients after treatment.
Measure:Overall response rate
Time Frame:Up to 60 days
Safety Issue:
Description:Proportion of subjects who achieve a complete remission [CR] or CR with partial recovery [CRh] of blood counts

Details

Phase:Phase 3
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:GlycoMimetics Incorporated

Trial Keywords

  • acute myeloid leukemia
  • AML
  • Relapsed AML
  • Refractory AML

Last Updated

October 31, 2019