Leukemia, Myeloid, Acute
Conditions
Keywords
AML, Acute myeloid leukemia, E-selectin, relapse refractory, elderly newly diagnosed, induction
Brief summary
This study will evaluate GMI-1271, a specific E-selectin antagonist, in acute myeloid leukemia in combination with standard agents used to treat this disease.
Interventions
DRUGCytarabine
induction chemotherapy
DRUGIdarubicin
induction chemotherapy
DRUGGMI-1271
E-selectin antagonist
DRUGMitoxantrone
induction chemotherapy
DRUGEtoposide
induction chemotherapy
Sponsors
GlycoMimetics Incorporated
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. AML (including secondary AML) diagnosed as per WHO criteria 2. For relapsed/refractory subjects only: * Subjects age ≥ 18 years with relapsed or refractory AML after ≤ 2 prior induction regimens, at least one containing anthracyclines * Medically eligible to receive MEC * Absolute blast count (ABC) ≤ 40,000/mm 3. For treatment-naïve subjects only: * Subjects ≥ 60 years of age with newly diagnosed AML * Medically eligible to receive 7+3 cytarabine/idarubicin * ABC count ≤ 40,000/mm 4. ECOG performance status 0-2 5. Hemodynamically stable and adequate organ function
Exclusion criteria
1. Acute promyelocytic leukemia 2. Acute leukemia of ambiguous lineage (biphenotypic leukemia) 3. Active signs or symptoms of CNS involvement by malignancy 4. No prior G-CSF, GM-CSF or plerixafor within 14 days of study drug dosing 5. Known history or evidence of active hepatitis A, B, or C or HIV 6. Uncontrolled acute life threatening bacterial, viral or fungal infection 7. Active graft versus host disease (GVHD) ≥ Grade 2 or extensive chronic GVHD requiring immunosuppressive therapy 8. Hematopoietic stem cell transplantation ≤ 4 months of dosing 9. Clinically significant cardiovascular disease
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety assessed by frequency, severity and relatedness of adverse events | up to 44 days |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall response rate | up to 12 months | Proportion of subjects who achieve a complete response (CR) or CR with incomplete blood count recovery (CRi) per local investigator assessment |
| Time to response | up to 12 months | Time from date of first dose to first documentation of response |
| Time versus plasma concentration profile of GMI-1271 | up to 11 days | Plasma concentration of GMI-1271 |
| Event-free survival | up to 12 months | Time from date of first dose to the date of treatment failure, relapse, or death from any cause, whichever occurs first |
| Overall survival | up to 12 months | The probability of survival at 6 months (Phase 1) and 12 months (Phase 2), after the date of first dose of study drug |
| Duration of response | up to 12 months | Time from date of first documented remission to the date of relapse or death from any cause, whichever occurs first |
Countries
Australia, Ireland, United States
Outcome results
None listed