Acute Myeloid Leukemia
Conditions
Keywords
acute myeloid leukemia, AML, Relapsed AML, Refractory AML
Brief 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
Interventions
DRUGUproleselan
A rationally designed E-selectin antagonist used to inhibit binding of cells to E-selectin
DRUGPlacebo
Saline, 0.9% Sodium Chloride
Sponsors
GlycoMimetics Incorporated
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall survival | 5 years | Time from the date of randomization into the study to the date of death. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall response rate | Up to 60 days | Proportion of subjects who achieve a complete remission \[CR\] or CR with partial recovery \[CRh\] of blood counts |
| Rate of severe oral mucositis | up to 60 days | Incidence of severe oral mucositis experienced in patients after treatment. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Pharmacokinetic exposure (amount of uproleselan in the blood) | up to 6 days | The amount of uproleselan in the blood over time. |
| Event-free survival | 5 years | Time from date of randomization into the study to the date of treatment failure, relapse, or death from any cause; whichever occurs first. |
| Overall survival | 2 years | Landmark analysis: Time from the date of randomization into the study to the date of death. |
| Duration of remission | 5 years | Time from date of first documented remission to date of relapse or death from any cause, whichever occurs first. |
| Adverse events | up to 5 months | Frequency, severity, and relatedness of adverse events. |
Countries
Australia, Canada, France, Ireland, Italy, Netherlands, Spain, United Kingdom, United States
Outcome results
None listed