Study to Determine Safety, Pharmacokinetics and Efficacy of GMI-1271 in Combination With Chemotherapy in AML

• Status: Completed
• Trial end date: 2018-05-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: GlycoMimetics Incorporated
• Treatments: Cytarabine; Etoposide; Idarubicin; Mitoxantrone

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) ≤ 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