Study to Determine Safety, Pharmacokinetics and Efficacy of GMI-1271 in Combination With Chemotherapy in AML
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ClinicalTrials.gov Identifier: NCT02306291 |
Recruitment Status :
Completed
First Posted : December 3, 2014
Last Update Posted : May 17, 2019
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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 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 |

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 |
- Safety assessed by frequency, severity and relatedness of adverse events [ Time Frame: up to 44 days ]
- Time versus plasma concentration profile of GMI-1271 [ Time Frame: up to 11 days ]Plasma concentration of GMI-1271
- 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
- Time to response [ Time Frame: up to 12 months ]Time from date of first dose to first documentation of response
- 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
- 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
- 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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion criteria:
- AML (including secondary AML) diagnosed as per WHO criteria
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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
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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

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
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 |
Principal Investigator: | Daniel DeAngelo, MD, PhD | Dana-Farber Cancer Institute |
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 |
AML Acute myeloid leukemia E-selectin |
relapse refractory elderly newly diagnosed induction |
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 |