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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 : May 14, 2019
Sponsor:
Information provided by (Responsible Party):
GlycoMimetics Incorporated

Tracking Information
First Submitted Date  ICMJE July 26, 2018
First Posted Date  ICMJE August 6, 2018
Last Update Posted Date May 14, 2019
Actual Study Start Date  ICMJE October 15, 2018
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 27, 2018)
Overall survival [ Time Frame: 5 years ]
Time from the date of randomization into the study to the date of death.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03616470 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: July 27, 2018)
  • Rate of severe oral mucositis [ Time Frame: up to 60 days ]
    Incidence of severe oral mucositis experienced in patients after treatment.
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: July 27, 2018)
  • 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.
  • 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.
  • Adverse events [ Time Frame: up to 5 months ]
    Frequency, severity, and relatedness of adverse events.
  • Pharmacokinetic exposure (amount of uproleselan in the blood) [ Time Frame: up to 6 days ]
    The amount of uproleselan in the blood over time.
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Study to Determine the Efficacy of Uproleselan (GMI-1271) in Combination With Chemotherapy to Treat Relapsed/Refractory Acute Myeloid Leukemia
Official Title  ICMJE 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
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
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Acute Myeloid Leukemia
Intervention  ICMJE
  • Drug: Uproleselan
    A rationally designed E-selectin antagonist used to inhibit binding of cells to E-selectin
  • Drug: Placebo
    Saline, 0.9% Sodium Chloride
Study Arms  ICMJE
  • Experimental: Uproleselan (GMI-1271)
    Uproleselan in combination with mitoxantrone, etoposide and cytarabine (MEC) or fludarabine, cytarabine and idarubicin (FAI)
    Intervention: Drug: Uproleselan
  • Placebo Comparator: Placebo (Saline, 0.9% Sodium Chloride)
    Placebo in combination with mitoxantrone, etoposide and cytarabine (MEC) or fludarabine, cytarabine and idarubicin (FAI)
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: July 27, 2018)
380
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2023
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: GlycoMimetics, Inc. 240-243-1201 clinicaltrials@glycomimetics.com
Listed Location Countries  ICMJE Australia,   Ireland,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03616470
Other Study ID Numbers  ICMJE GMI-1271-301
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party GlycoMimetics Incorporated
Study Sponsor  ICMJE GlycoMimetics Incorporated
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Daniel J DeAngelo, MD, PhD Dana-Farber Cancer Institute
PRS Account GlycoMimetics Incorporated
Verification Date May 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP