Study to Determine Safety, Pharmacokinetics and Efficacy of GMI-1271 in Combination With Chemotherapy in AML
Conditions
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
Interventional
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
Intervention
Name: GMI-1271 Type: Drug
Name: GMI-1271 Type: Drug
Name: GMI-1271 Type: Drug
Overall Status
Recruiting
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.
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
Locations
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
Sponsors
GlycoMimetics Incorporated
Source
GlycoMimetics Incorporated
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page