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
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
Interventions
Drug | Synonyms | Arms |
---|
Uproleselan | | Uproleselan (GMI-1271) |
Placebo | | Placebo (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
Name | Type | Description | Interventions |
---|
Uproleselan (GMI-1271) | Experimental | Uproleselan in combination with mitoxantrone, etoposide and cytarabine (MEC) or fludarabine, cytarabine and idarubicin (FAI) | |
Placebo (Saline, 0.9% Sodium Chloride) | Placebo Comparator | Placebo in combination with mitoxantrone, etoposide and cytarabine (MEC) or fludarabine, cytarabine and idarubicin (FAI) | |
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
August 30, 2021