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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02306291
Recruitment Status : Completed
First Posted : December 3, 2014
Last Update Posted : May 17, 2019
Sponsor:
Information provided by (Responsible Party):
GlycoMimetics Incorporated

Study Description
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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.

Condition or disease Intervention/treatment Phase
Leukemia, Myeloid, Acute Drug: GMI-1271 Drug: Mitoxantrone Drug: Etoposide Drug: Cytarabine Drug: Idarubicin Phase 1 Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 91 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : March 2015
Actual Primary Completion Date : December 2017
Actual Study Completion Date : May 2018

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Arm A (Phase I)
GMI-1271 in combination with mitoxantrone, etoposide and cytarabine (MEC) in relapsed/refractory subjects 18 years and older
 Drug: GMI-1271
E-selectin antagonist
Other Name: Uproleselan

Drug: Mitoxantrone
induction chemotherapy

Drug: Etoposide
induction chemotherapy

Drug: Cytarabine
induction chemotherapy
Experimental: Arm B (Phase II Arm A)
GMI-1271 in combination with mitoxantrone, etoposide and cytarabine (MEC) in relapsed/refractory subjects 18 years and older
 Drug: GMI-1271
E-selectin antagonist
Other Name: Uproleselan

Drug: Mitoxantrone
induction chemotherapy

Drug: Etoposide
induction chemotherapy

Drug: Cytarabine
induction chemotherapy
Experimental: Arm C (Phase II Arm B)
GMI-1271 in combination with cytarabine and idarubicin (7+3 regimen) in newly diagnosed subjects 60 years and older
 Drug: GMI-1271
E-selectin antagonist
Other Name: Uproleselan

Drug: Cytarabine
induction chemotherapy

Drug: Idarubicin
induction chemotherapy


Outcome Measures
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Primary Outcome Measures :
  1. Safety assessed by frequency, severity and relatedness of adverse events [ Time Frame: up to 44 days ]

Secondary Outcome Measures :
  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


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02306291


Locations
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United States, California
University of California, Davis Comprehensive Cancer Center
Sacramento, California, United States, 95817
United States, Massachusetts
Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02115
United States, Michigan
University of Michigan, Ann Arbor
Ann Arbor, Michigan, United States, 48109
United States, New York
University of Rochester
Rochester, New York, United States, 14642
United States, Ohio
Cleveland Clinic
Cleveland, Ohio, United States, 44195
United States, Washington
University of Washington
Seattle, Washington, United States, 98109
Australia
Princess Alexandra Hospital
Brisbane, Australia
Ireland
University Hospital Galway
Galway, Ireland
Sponsors and Collaborators
GlycoMimetics Incorporated
Investigators
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Principal Investigator: Daniel DeAngelo, MD, PhD Dana-Farber Cancer Institute
More Information
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Responsible Party: GlycoMimetics Incorporated
ClinicalTrials.gov Identifier: NCT02306291    
Other Study ID Numbers: GMI-1271-201
First Posted: December 3, 2014    Key Record Dates
Last Update Posted: May 17, 2019
Last Verified: May 2019
Keywords provided by GlycoMimetics Incorporated:
AML
Acute myeloid leukemia
E-selectin
 relapse refractory
elderly newly diagnosed
induction
Additional relevant MeSH terms:
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Leukemia
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Neoplasms by Histologic Type
Neoplasms
Cytarabine
Etoposide
Mitoxantrone
Idarubicin
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
 Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Antimetabolites
Antiviral Agents
Anti-Infective Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Antibiotics, Antineoplastic