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Study to Determine Safety, Pharmacokinetics and Efficacy of GMI-1271 in Combination With Chemotherapy in AML | Clinical Trials | Clareo Health

COMPLETEDPHASE1/PHASE2

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

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

NCT02306291•GlycoMimetics Incorporated

View on ClinicalTrials.gov

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

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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
+1 more criteria

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 (8)

University of California, Davis Comprehensive Cancer Center

Sacramento, California, United States

Dana Farber Cancer Institute

Boston, Massachusetts, United States

University of Michigan, Ann Arbor

Ann Arbor, Michigan, United States

University of Rochester

Rochester, New York, United States

Cleveland Clinic

Cleveland, Ohio, United States

University of Washington

Seattle, Washington, United States

Princess Alexandra Hospital

Brisbane, Australia

University Hospital Galway

Galway, Ireland

Key Dates

Start Date

March 1, 2015

Primary Completion Date

December 1, 2017

Completion Date

May 1, 2018

Last Updated

May 17, 2019

Enrollment

ACTUAL participants

Conditions

Leukemia, Myeloid, Acute

Interventions

GMI-1271

DRUG

Mitoxantrone

DRUG

Etoposide

DRUG

Cytarabine

DRUG

Idarubicin

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: May 17, 2019Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

A Study of Bleximenib, Venetoclax and Azacitidine For Treatment of Participants With Newly Diagnosed Acute Myeloid Leukemia (AML)

Toxicity Genetic Determinants and Response to Azacitidine and Venetoclax in AML

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