Clinical trial · Interventional
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Trial failed to meet primary endpoint.
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Acute Myeloid Leukemia | Acute Myeloid Leukemia | CURATED_BROADER | 0.80 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Placebo | Drug | — | UNRESOLVED |
| Uproleselan | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Uproleselan (GMI-1271)
- description
- Uproleselan in combination with mitoxantrone, etoposide and cytarabine (MEC) or fludarabine, cytarabine and idarubicin (FAI)
- interventionNames
- Drug: Uproleselan
- type
- PLACEBO_COMPARATOR
- label
- Placebo (Saline, 0.9% Sodium Chloride)
- description
- Placebo in combination with mitoxantrone, etoposide and cytarabine (MEC) or fludarabine, cytarabine and idarubicin (FAI)
- interventionNames
- Drug: Placebo
Primary outcomes (1)
- measure
- Overall survival
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available