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Study to Determine the Efficacy of Uproleselan (GMI-1271) in Combination With Chemotherapy to Treat Relapsed/Refractory Acute Myeloid Leukemia

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ClinicalTrials.gov Identifier: NCT03616470
Recruitment Status : Recruiting
First Posted : August 6, 2018
Last Update Posted : August 5, 2019
Sponsor:
Information provided by (Responsible Party):
GlycoMimetics Incorporated

Brief Summary:
This study will evaluate the efficacy of uproleselan (GMI-1271), a specific E-selectin antagonist, in combination with chemotherapy to treat relapsed/refractory AML, compared to chemotherapy alone. The safety of uproleselan when given with chemotherapy will also be investigated in patients with relapsed/refractory AML

Condition or disease Intervention/treatment Phase
Acute Myeloid Leukemia Drug: Uproleselan Drug: Placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 380 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase III Randomized, Double-Blind Trial to Evaluate the Efficacy of Uproleselan Administered With Chemotherapy Versus Chemotherapy Alone in Patients With Relapsed/Refractory Acute Myeloid Leukemia
Actual Study Start Date : October 15, 2018
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2023


Arm Intervention/treatment
Experimental: Uproleselan (GMI-1271)
Uproleselan in combination with mitoxantrone, etoposide and cytarabine (MEC) or fludarabine, cytarabine and idarubicin (FAI)
Drug: Uproleselan
A rationally designed E-selectin antagonist used to inhibit binding of cells to E-selectin

Placebo Comparator: Placebo (Saline, 0.9% Sodium Chloride)
Placebo in combination with mitoxantrone, etoposide and cytarabine (MEC) or fludarabine, cytarabine and idarubicin (FAI)
Drug: Placebo
Saline, 0.9% Sodium Chloride




Primary Outcome Measures :
  1. Overall survival [ Time Frame: 5 years ]
    Time from the date of randomization into the study to the date of death.


Secondary Outcome Measures :
  1. Rate of severe oral mucositis [ Time Frame: up to 60 days ]
    Incidence of severe oral mucositis experienced in patients after treatment.

  2. Overall response rate [ Time Frame: Up to 60 days ]
    Proportion of subjects who achieve a complete remission [CR] or CR with partial recovery [CRh] of blood counts


Other Outcome Measures:
  1. Event-free survival [ Time Frame: 2 years ]
    Time from date of randomization into the study to the date of treatment failure, relapse, or death from any cause; whichever occurs first.

  2. Duration of remission [ Time Frame: 2 years ]
    Time from date of first documented remission to date of relapse or death from any cause, whichever occurs first.

  3. Adverse events [ Time Frame: up to 5 months ]
    Frequency, severity, and relatedness of adverse events.

  4. Pharmacokinetic exposure (amount of uproleselan in the blood) [ Time Frame: up to 6 days ]
    The amount of uproleselan in the blood over time.



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • ≥18 years and ≤75 years in age
  • Patients with relapsed or refractory AML
  • No more than one prior stem cell transplant
  • Has not received the chemotherapy regimen to be used for induction on this trial
  • Is considered medically eligible to receive the chemotherapy regimen to be used for induction on this trial

Exclusion Criteria:

  • Patients with acute promyelocytic leukemia, acute leukemia of ambiguous lineage (biphenotypic leukemia), chronic myeloid leukemia with myeloid blast crisis, or secondary refractory AML.
  • Active signs or symptoms of CNS involvement by malignancy.
  • Stem cell transplantation ≤4 months prior to dosing.
  • Any immunotherapy or radiotherapy therapy within 28 days of dosing; any other experimental therapy or chemotherapy within 14 days of dosing.
  • Prior use of G-CSF, CM-CSF or plerixafor within 7 days of dosing.
  • Inadequate organ function.
  • Abnormal liver function.
  • Known active infection with hepatitis A, B, or C, or human immunodeficiency virus.
  • Moderate kidney dysfunction (glomerular filtration rate <45 mL/min).
  • Uncontrolled acute life-threatening bacterial, viral, or fungal infection.
  • Clinically significant cardiovascular disease.
  • Major surgery within 4 weeks of dosing.

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): NCT03616470


Contacts
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Contact: GlycoMimetics, Inc. 240-243-1201 clinicaltrials@glycomimetics.com

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Sponsors and Collaborators
GlycoMimetics Incorporated
Investigators
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Principal Investigator: Daniel J DeAngelo, MD, PhD Dana-Farber Cancer Institute

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Responsible Party: GlycoMimetics Incorporated
ClinicalTrials.gov Identifier: NCT03616470     History of Changes
Other Study ID Numbers: GMI-1271-301
First Posted: August 6, 2018    Key Record Dates
Last Update Posted: August 5, 2019
Last Verified: August 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by GlycoMimetics Incorporated:
acute myeloid leukemia
AML
Relapsed AML
Refractory AML

Additional relevant MeSH terms:
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Leukemia
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Neoplasms by Histologic Type
Neoplasms