Clinical trial NCT02306291: Study to Determine Safety, Pharmacokinetics and Efficacy of GMI-1271 in Combination With Chemotherapy in AML
Official title: A Phase I/II, Open-label Multicenter Trial to Determine Safety, Pharmacokinetics and Efficacy of GMI-1271 in Combination With Chemotherapy in Patients With Acute Myeloid Leukemia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Leukemia, Myeloid, Acute
Keywords: AML
Acute myeloid leukemia
E-selectin
relapse refractory
elderly newly diagnosed
induction
Lead sponsor: GlycoMimetics Incorporated
Sponsor class: INDUSTRY
First posted: 2014-12-03
Enrollment: 91
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Safety assessed by frequency, severity and relatedness of adverse events
timeFrame: up to 44 days
Secondary outcomes:
measure: Time versus plasma concentration profile of GMI-1271
timeFrame: up to 11 days
measure: Overall response rate
timeFrame: up to 12 months
measure: Time to response
timeFrame: up to 12 months
measure: Duration of response
timeFrame: up to 12 months
measure: Event-free survival
timeFrame: up to 12 months
measure: Overall survival
timeFrame: up to 12 months
Other outcomes:
Locations:
city: Sacramento
country: United States
facility: University of California, Davis Comprehensive Cancer Center
state: California
city: Boston
country: United States
facility: Dana Farber Cancer Institute
state: Massachusetts
city: Ann Arbor
country: United States
facility: University of Michigan, Ann Arbor
state: Michigan
city: Rochester
country: United States
facility: University of Rochester
state: New York
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
city: Seattle
country: United States
facility: University of Washington
state: Washington
city: Brisbane
country: Australia
facility: Princess Alexandra Hospital
city: Galway
country: Ireland
facility: University Hospital Galway
Study officials:
affiliation: Dana-Farber Cancer Institute
name: Daniel DeAngelo, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: DeAngelo DJ, Jonas BA, Liesveld JL, Bixby DL, Advani AS, Marlton P, Magnani JL, Thackray HM, Feldman EJ, O'Dwyer ME, Becker PS. Phase 1/2 study of uproleselan added to chemotherapy in patients with relapsed or refractory acute myeloid leukemia. Blood. 2022 Feb 24;139(8):1135-1146. doi: 10.1182/blood.2021010721.