Skip to main content
OpenTrials
Completed

NCT Number: NCT02306291

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Leukemia, Myeloid, Acute Hematologic Diseases Hemic and Lymphatic Diseases Leukemia Leukemia, Myeloid Neoplasms Neoplasms by Histologic Type

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Princess Alexandra Hospital, Brisbane, Australia

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • AML (including secondary AML) diagnosed as per WHO criteria
  • 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
  • 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
  • ECOG performance status 0-2
  • Hemodynamically stable and adequate organ function

Exclusion criteria

  • Acute promyelocytic leukemia
  • Acute leukemia of ambiguous lineage (biphenotypic leukemia)
  • Active signs or symptoms of CNS involvement by malignancy
  • No prior G-CSF, GM-CSF or plerixafor within 14 days of study drug dosing
  • Known history or evidence of active hepatitis A, B, or C or HIV
  • Uncontrolled acute life threatening bacterial, viral or fungal infection
  • Active graft versus host disease (GVHD) ≥ Grade 2 or extensive chronic GVHD requiring immunosuppressive therapy
  • Hematopoietic stem cell transplantation ≤ 4 months of dosing
  • Clinically significant cardiovascular disease

Treatment and study plan

GMI-1271

Drug

E-selectin antagonist

Other names: Uproleselan

Mitoxantrone

Drug

induction chemotherapy

etoposide

Drug

induction chemotherapy

Cytarabine

Drug

induction chemotherapy

Idarubicin

Drug

induction chemotherapy

Primary outcomes

  1. Safety assessed by frequency, severity and relatedness of adverse events

    Time frame: up to 44 days

Secondary outcomes

  1. Time versus plasma concentration profile of GMI-1271

    Time frame: up to 11 days

    Plasma concentration of GMI-1271

  2. Overall response rate

    Time frame: 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

  3. Time to response

    Time frame: up to 12 months

    Time from date of first dose to first documentation of response

  4. Duration of response

    Time frame: up to 12 months

    Time from date of first documented remission to the date of relapse or death from any cause, whichever occurs first

  5. Event-free survival

    Time frame: 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

  6. Overall survival

    Time frame: 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

Sponsors and collaborators

Lead sponsor

GlycoMimetics Incorporated

Industry

Registry information

Official study 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

Important dates

Study start
2015
Primary completion
2017
Study completion
2018
First posted
Dec 3, 2014
Registry last updated
May 17, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.