Acute Myeloid Leukemia Clinical Trial
Study to Determine the Efficacy of Uproleselan (GMI-1271) in Combination With Chemotherapy to Treat Relapsed/Refractory Acute Myeloid Leukemia
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
Eligibility 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.
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There are 65 Locations for this study
La Jolla California, 92093, United States
Los Angeles California, 90095, United States
Orange California, 92868, United States
Palo Alto California, 94304, United States
Sacramento California, 95817, United States
Atlanta Georgia, 30322, United States
Atlanta Georgia, 30342, United States
Chicago Illinois, 60612, United States
Westwood Kansas, 66205, United States
Boston Massachusetts, 02215, United States
Ann Arbor Michigan, 48109, United States
Detroit Michigan, 48201, United States
Saint Louis Missouri, 63110, United States
Buffalo New York, 14263, United States
Hawthorne New York, 10532, United States
New York New York, 10032, United States
New York New York, 10065, United States
New York New York, 10065, United States
Rochester New York, 14642, United States
Durham North Carolina, 27710, United States
Winston-Salem North Carolina, 27157, United States
Cleveland Ohio, 44106, United States
Cleveland Ohio, 44195, United States
Columbus Ohio, 43210, United States
Oklahoma City Oklahoma, 73104, United States
Nashville Tennessee, 37203, United States
Dallas Texas, 75246, United States
Houston Texas, 77030, United States
Salt Lake City Utah, 84112, United States
Seattle Washington, 98109, United States
Waratah New South Wales, 2298, Australia
Nedlands Perth, 6009, Australia
Douglas Queensland, 4814, Australia
Woolloongabba Queensland, 4102, Australia
Bedford Park South Australia, 5042, Australia
Heidelberg Victoria, 3084, Australia
Calgary Alberta, T2N 4, Canada
Edmonton Alberta, , Canada
Vancouver British Columbia, , Canada
Winnipeg Manitoba, R3E0V, Canada
Hamilton Ontario, L8V 5, Canada
Toronto Ontario, M5G 2, Canada
Angers , 49933, France
Bordeaux , 33604, France
La Tronche , 38700, France
Marseille , 13273, France
Paris , 75010, France
Pierre-Bénite , 75010, France
Poitiers , 86021, France
Galway , H91 T, Ireland
San Giovanni Rotondo FG, , Italy
Bologna , 40138, Italy
Meldola , 47014, Italy
Ravenna , 48121, Italy
Roma , 00133, Italy
Rome , 00168, Italy
Treviso , 31100, Italy
Amsterdam , 1081 , Netherlands
Groningen , 9713 , Netherlands
Utrecht , 3584, Netherlands
Cáceres , 10003, Spain
Madrid , 28033, Spain
Madrid , 28040, Spain
Málaga , 29010, Spain
Pamplona , 31008, Spain
Salamanca , 37007, Spain
Santander , 39008, Spain
Valencia , 46026, Spain
Oxford England, OX3 7, United Kingdom
Cardiff , CF14 , United Kingdom
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