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Trial failed to meet primary endpoint.
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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Uproleselan (GMI-1271) | Experimental | Uproleselan in combination with mitoxantrone, etoposide and cytarabine (MEC) or fludarabine, cytarabine and idarubicin (FAI) |
|
| Placebo (Saline, 0.9% Sodium Chloride) | Placebo Comparator | Placebo in combination with mitoxantrone, etoposide and cytarabine (MEC) or fludarabine, cytarabine and idarubicin (FAI) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Uproleselan | Drug | A rationally designed E-selectin antagonist used to inhibit binding of cells to E-selectin |
|
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival | Time from the date of randomization into the study to the date of death. | 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of severe oral mucositis | Incidence of severe oral mucositis experienced in patients after treatment. | up to 60 days |
| Overall response rate | Proportion of subjects who achieve a complete remission [CR] or CR with partial recovery [CRh] of blood counts |
| Measure | Description | Time Frame |
|---|---|---|
| Event-free survival | Time from date of randomization into the study to the date of treatment failure, relapse, or death from any cause; whichever occurs first. | 5 years |
| Duration of remission | Time from date of first documented remission to date of relapse or death from any cause, whichever occurs first. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Daniel J DeAngelo, MD, PhD | Dana-Farber Cancer Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UC San Diego Moore Cancer Center | La Jolla | California | 92093 | United States | ||
| University of California, Los Angeles - UCLA |
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| Placebo | Drug | Saline, 0.9% Sodium Chloride |
|
| Up to 60 days |
| 5 years |
| Adverse events | Frequency, severity, and relatedness of adverse events. | up to 5 months |
| Pharmacokinetic exposure (amount of uproleselan in the blood) | The amount of uproleselan in the blood over time. | up to 6 days |
| Event-free survival | Landmark analysis: Time from date of randomization into the study to the date of relapse or death from any cause; whichever occurs first. | 1 year |
| Overall survival | Landmark analysis: Time from the date of randomization into the study to the date of death. | 2 years |
| Overall survival | Landmark analysis: Time from the date of randomization into the study to the date of death. | 3 years |
| Overall survival | Landmark analysis: Time from the date of randomization into the study to the date of death. | 4 years |
| Los Angeles |
| California |
| 90095 |
| United States |
| University of California Irvine | Orange | California | 92868 | United States |
| Stanford Cancer Institute | Palo Alto | California | 94304 | United States |
| UC Davis Comprehensive Cancer Center | Sacramento | California | 95817 | United States |
| Emory Winship Cancer Institute | Atlanta | Georgia | 30322 | United States |
| Northside Hospital - Medical Tower | Atlanta | Georgia | 30342 | United States |
| Rush University Medical Center | Chicago | Illinois | 60612 | United States |
| The University of Kansas Cancer Center | Westwood | Kansas | 66205 | United States |
| Dana Farber Cancer Institute | Boston | Massachusetts | 02215 | United States |
| University of Michigan | Ann Arbor | Michigan | 48109 | United States |
| Barbara Ann Karmanos Cancer Institute | Detroit | Michigan | 48201 | United States |
| Washington University School of Medicine | St Louis | Missouri | 63110 | United States |
| Roswell Park Cancer Institute | Buffalo | New York | 14263 | United States |
| Hudson Valley Cancer Center | Hawthorne | New York | 10532 | United States |
| Columbia University Herbert Irving Comprehensive Cancer Center | New York | New York | 10032 | United States |
| Memorial Sloan Kettering Cancer Center | New York | New York | 10065 | United States |
| Weill Cornell Medical College | New York | New York | 10065 | United States |
| University of Rochester Medical Center | Rochester | New York | 14642 | United States |
| Duke University Health System (DUHS) | Durham | North Carolina | 27710 | United States |
| Wake Forest Baptist Hospital | Winston-Salem | North Carolina | 27157 | United States |
| University Hospital Cleveland Medical Center | Cleveland | Ohio | 44106 | United States |
| Cleveland Clinic | Cleveland | Ohio | 44195 | United States |
| The Ohio State University Wexner Medical Center and James Cancer Hospital | Columbus | Ohio | 43210 | United States |
| Stephenson Cancer Center | Oklahoma City | Oklahoma | 73104 | United States |
| Vanderbilt-Ingram Cancer Center Clinical Trials Office | Nashville | Tennessee | 37203 | United States |
| Charles A. Sammons Cancer Center at Dallas | Dallas | Texas | 75246 | United States |
| The University of Texas MD Anderson Cancer Center | Houston | Texas | 77030 | United States |
| Huntsman Cancer Institute, University of Utah | Salt Lake City | Utah | 84112 | United States |
| Seattle Cancer Care Alliance | Seattle | Washington | 98109 | United States |
| Calvary Mater Newcastle | Waratah | New South Wales | 2298 | Australia |
| Sir Charles Gairdner Hospital | Nedlands | Perth | 6009 | Australia |
| Townsville Hospital | Douglas | Queensland | 4814 | Australia |
| Princess Alexandra Hospital | Woolloongabba | Queensland | 4102 | Australia |
| Flinders Medical Centre | Bedford Park | South Australia | 5042 | Australia |
| Cancer Clinical Trials Centre (CCTC) | Heidelberg | Victoria | 3084 | Australia |
| Tom Baker Cancer Center | Calgary | Alberta | T2N 4N2 | Canada |
| University of Alberta Princess Margaret Hospital | Edmonton | Alberta | Canada |
| The Leukemia/BMT Program of BC Vancouver General Hospital | Vancouver | British Columbia | Canada |
| CancerCare Manitoba | Winnipeg | Manitoba | R3E0V9 | Canada |
| Juravinski Cancer Centre | Hamilton | Ontario | L8V 5C2 | Canada |
| University Health Network (UHN) - Princess Margaret Cancer Centre | Toronto | Ontario | M5G 2MG | Canada |
| Centre Hospitalier Universitaire d'Angers | Angers | 49933 | France |
| Centre Hospitalier Universitaire de Bordeaux | Bordeaux | 33604 | France |
| Centre Hospitalier Universitaire Grenoble Alpes | La Tronche | 38700 | France |
| Unité d'Evaluation Thérapeutique en Onco-Hématologie (ETHO) | Marseille | 13273 | France |
| Saint-Louis Hospital | Paris | 75010 | France |
| Centre Hospitalier Lyon Sud | Pierre-Bénite | 75010 | France |
| Centre Hospitalier Universitaire de Poitiers | Poitiers | 86021 | France |
| Galway University Hospital | Galway | H91 TK33 | Ireland |
| IRCCS Casa Sollievo della Sofferenza Hospital | San Giovanni Rotondo | FG | Italy |
| Institute of Hematology and Medical Oncology "L. and A. Seràgnoli" | Bologna | 40138 | Italy |
| Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) | Meldola | 47014 | Italy |
| Hospital of Ravenna | Ravenna | 48121 | Italy |
| Fondazione Policlinico Tor Vergata, U.O.C. Ematologia | Roma | 00133 | Italy |
| Università Cattolica del Sacro Cuore (UNICATT) | Rome | 00168 | Italy |
| Ca' Foncello Hospital | Treviso | 31100 | Italy |
| VU University Medical Center | Amsterdam | 1081 HV | Netherlands |
| University Medical Center Groningen | Groningen | 9713 GZ | Netherlands |
| University Medical Centre Utrecht | Utrecht | 3584 | Netherlands |
| Hospital San Pedro De Alcantra | Cáceres | 10003 | Spain |
| Hospital MDACC | Madrid | 28033 | Spain |
| Hospital Universitario Fundación Jiménez Diaz | Madrid | 28040 | Spain |
| Hospital Virgen de la Victoria, Málaga | Málaga | 29010 | Spain |
| Clínica Universidad de Navarra | Pamplona | 31008 | Spain |
| Hospital Universitario de Salamanca | Salamanca | 37007 | Spain |
| University Hospital of Hospital Marqués de Valdecilla | Santander | 39008 | Spain |
| Hospital Universitari i Politècnic La Fe | Valencia | 46026 | Spain |
| Radcliffe Hospitals and University of Oxford | Oxford | England | OX3 7LJ | United Kingdom |
| Cardiff University School of Medicine | Cardiff | CF14 4XN | United Kingdom |
| ID | Term |
|---|---|
| D015470 | Leukemia, Myeloid, Acute |
| ID | Term |
|---|---|
| D007951 | Leukemia, Myeloid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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| ID | Term |
|---|---|
| C000654285 | uproleselan |
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