Trials / Terminated
TerminatedNCT03616470
Study to Determine the Efficacy of Uproleselan (GMI-1271) in Combination With Chemotherapy to Treat Relapsed/Refractory Acute Myeloid Leukemia
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
- Status
- Terminated
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 388 (actual)
- Sponsor
- GlycoMimetics Incorporated · Industry
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
Summary
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
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Uproleselan | A rationally designed E-selectin antagonist used to inhibit binding of cells to E-selectin |
| DRUG | Placebo | Saline, 0.9% Sodium Chloride |
Timeline
- Start date
- 2018-10-15
- Primary completion
- 2024-03-31
- Completion
- 2024-03-31
- First posted
- 2018-08-06
- Last updated
- 2024-07-29
Locations
70 sites across 9 countries: United States, Australia, Canada, France, Ireland, Italy, Netherlands, Spain, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03616470. Inclusion in this directory is not an endorsement.