Study to Determine Safety, Pharmacokinetics and Efficacy of GMI-1271 in Combination With Chemotherapy in AML
Leukemia, Myeloid, Acute
Conditions: official terms
Leukemia, Myeloid - Leukemia, Myeloid, Acute
Conditions: Keywords
AML, Acute myeloid leukemia, E-selectin, relapse refractory, elderly newly diagnosed, induction
Study Type
Study Phase
Phase 1/Phase 2
Study Design
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Name: GMI-1271 Type: Drug
Name: GMI-1271 Type: Drug
Name: GMI-1271 Type: Drug
Overall Status
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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both
Criteria: 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) ≤ 20,000/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
Dana Farber Cancer Institute
Boston, Massachusetts, United States
Status: Not yet recruiting
Contact: Shannon Milillo - 617-632-4912
University of Michigan, Ann Arbor
Ann Arbor, Michigan, United States
Status: Recruiting
Contact: Cancer Answer Line - 800-865-1125
University of Rochester
Rochester, New York, United States
Status: Recruiting
Contact: Jessica Mavor - 585-275-9485
University Hospital Galway
Galway, Ireland
Status: Recruiting
Contact: Veronica McInerney - 353 91 49 4031
Start Date
March 2015
Completion Date
December 2017
GlycoMimetics Incorporated
GlycoMimetics Incorporated
Record processing date processed this data on July 28, 2015 page