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Leállítva3. fázis

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

Megadott ok: Trial failed to meet primary endpoint.

Key facts

Where
Ann Arbor, Atlanta, Boston, Buffalo, Chicago, Cleveland, Columbus, Dallas, Detroit, Durham, Hawthorne, Houston, La Jolla, Los Angeles, Nashville, New York, Oklahoma City, Orange, Palo Alto, Rochester, Sacramento, Salt Lake City, Seattle, St Louis, Westwood és Winston-Salem, Egyesült ÁllamokSee the 30 sites
Phase
3. fázis

Where in Egyesült Államok

  • University of MichiganAnn Arbor, Egyesült ÁllamokNo longer taking part
  • Emory Winship Cancer InstituteAtlanta, Egyesült ÁllamokNo longer taking part
  • Northside Hospital - Medical TowerAtlanta, Egyesült ÁllamokNo longer taking part
  • Dana-Farber Cancer InstituteBoston, Egyesült ÁllamokNo longer taking part
  • Roswell Park Cancer InstituteBuffalo, Egyesült ÁllamokNo longer taking part
  • Rush University Medical CenterChicago, Egyesült ÁllamokNo longer taking part
  • Cleveland ClinicCleveland, Egyesült ÁllamokNo longer taking part
  • University Hospital Cleveland Medical CenterCleveland, Egyesült ÁllamokNo longer taking part
  • The Ohio State University Wexner Medical Center and James Cancer HospitalColumbus, Egyesült ÁllamokNo longer taking part
  • Charles A. Sammons Cancer Center at DallasDallas, Egyesült ÁllamokNo longer taking part
  • Barbara Ann Karmanos Cancer InstituteDetroit, Egyesült ÁllamokNo longer taking part
  • Duke University Health System (DUHS)Durham, Egyesült ÁllamokNo longer taking part
  • Hudson Valley Cancer CenterHawthorne, Egyesült ÁllamokNo longer taking part
  • The University of Texas MD Anderson Cancer CenterHouston, Egyesült ÁllamokNo longer taking part
  • UC San Diego Moore Cancer CenterLa Jolla, Egyesült ÁllamokNo longer taking part
  • University of California Los Angeles (UCLA).Los Angeles, Egyesült ÁllamokNo longer taking part
  • Vanderbilt-Ingram Cancer Center Clinical Trials OfficeNashville, Egyesült ÁllamokNo longer taking part
  • Columbia University / Herbert Irving Comprehensive Cancer CenterNew York, Egyesült ÁllamokNo longer taking part
  • Memorial Sloan-Kettering Cancer CenterNew York, Egyesült ÁllamokNo longer taking part
  • Weill Cornell Medical CollegeNew York, Egyesült ÁllamokNo longer taking part
  • Stephenson Cancer CenterOklahoma City, Egyesült ÁllamokNo longer taking part
  • University of California IrvineOrange, Egyesült ÁllamokNo longer taking part
  • Stanford Cancer InstitutePalo Alto, Egyesült ÁllamokNo longer taking part
  • University of Rochester Medical CenterRochester, Egyesült ÁllamokNo longer taking part
  • UC Davis Comprehensive Cancer CenterSacramento, Egyesült ÁllamokNo longer taking part
  • Huntsman Cancer Institute/University of UtahSalt Lake City, Egyesült ÁllamokNo longer taking part
  • Seattle Cancer Care AllianceSeattle, Egyesült ÁllamokNo longer taking part
  • Washington University School of MedicineSt Louis, Egyesült ÁllamokNo longer taking part
  • The University of Kansas Cancer CenterWestwood, Egyesült ÁllamokNo longer taking part
  • Wake Forest Baptist HospitalWinston-Salem, Egyesült ÁllamokNo longer taking part

Trial details

Who runs it
GlycoMimetics Incorporated
Trial code
NCT03616470
Record updated
2024. július 29.
Original description
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 AMLRead full original descriptionShow less

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

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

Inclusion: ≥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: 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; Major surgery within 4 weeks of dosing; Active signs or symptoms of CNS involvement by malignancy; Known active infection with hepatitis A, B, or C, or human immunodeficiency virus; Uncontrolled acute life-threatening bacterial, viral, or fungal infection; Clinically significant cardiovascular disease; Patients with acute promyelocytic leukemia, acute leukemia of ambiguous lineage (biphenotypic leukemia), chronic myeloid leukemia with myeloid blast crisis, or secondary refractory AML; Inadequate organ function; Abnormal liver function; Moderate kidney dysfunction (glomerular filtration rate <45 mL/min).

ClinicalTrials.gov NCT03616470