Study to Determine the Efficacy of Uproleselan (GMI-1271) in Combination With Chemotherapy to Treat Relapsed/Refractory Acute Myeloid Leukemia
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ClinicalTrials.gov Identifier: NCT03616470 |
Recruitment Status :
Active, not recruiting
First Posted : August 6, 2018
Last Update Posted : April 6, 2022
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Acute Myeloid Leukemia | Drug: Uproleselan Drug: Placebo | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 388 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
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 |
Actual Study Start Date : | October 15, 2018 |
Estimated Primary Completion Date : | April 2022 |
Estimated Study Completion Date : | December 2023 |

Arm | Intervention/treatment |
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Experimental: Uproleselan (GMI-1271)
Uproleselan in combination with mitoxantrone, etoposide and cytarabine (MEC) or fludarabine, cytarabine and idarubicin (FAI)
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Drug: Uproleselan
A rationally designed E-selectin antagonist used to inhibit binding of cells to E-selectin |
Placebo Comparator: Placebo (Saline, 0.9% Sodium Chloride)
Placebo in combination with mitoxantrone, etoposide and cytarabine (MEC) or fludarabine, cytarabine and idarubicin (FAI)
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Drug: Placebo
Saline, 0.9% Sodium Chloride |
- Overall survival [ Time Frame: 5 years ]Time from the date of randomization into the study to the date of death.
- Rate of severe oral mucositis [ Time Frame: up to 60 days ]Incidence of severe oral mucositis experienced in patients after treatment.
- Overall response rate [ Time Frame: Up to 60 days ]Proportion of subjects who achieve a complete remission [CR] or CR with partial recovery [CRh] of blood counts
- Event-free survival [ Time Frame: 2 years ]Time from date of randomization into the study to the date of treatment failure, relapse, or death from any cause; whichever occurs first.
- Duration of remission [ Time Frame: 2 years ]Time from date of first documented remission to date of relapse or death from any cause, whichever occurs first.
- Adverse events [ Time Frame: up to 5 months ]Frequency, severity, and relatedness of adverse events.
- Pharmacokinetic exposure (amount of uproleselan in the blood) [ Time Frame: up to 6 days ]The amount of uproleselan in the blood over time.

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Ages Eligible for Study: | 18 Years to 75 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03616470

Principal Investigator: | Daniel J DeAngelo, MD, PhD | Dana-Farber Cancer Institute |
Responsible Party: | GlycoMimetics Incorporated |
ClinicalTrials.gov Identifier: | NCT03616470 |
Other Study ID Numbers: |
GMI-1271-301 |
First Posted: | August 6, 2018 Key Record Dates |
Last Update Posted: | April 6, 2022 |
Last Verified: | April 2022 |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
acute myeloid leukemia AML Relapsed AML Refractory AML |
Leukemia Leukemia, Myeloid Leukemia, Myeloid, Acute Neoplasms by Histologic Type Neoplasms |