Acute Myeloid Leukemia Clinical Trial
Entospletinib Monotherapy and in Combination With Chemotherapy in Adults With Acute Myeloid Leukemia (AML)
Summary
This study will evaluate the efficacy, safety, and tolerability of entospletinib when administered as monotherapy or in combination with chemotherapy in adults with acute myeloid leukemia (AML).
Eligibility Criteria
Key Inclusion Criteria:
Adults with AML in need of treatment
Group A : Individuals ≥ 18 years of age with previously untreated AML by World Health Organization (WHO) criteria who are able and should receive up to 2 cycles of induction chemotherapy with 7+3 as determined by the treating physician
Group B: Individuals > 70 years of age with previously untreated AML by WHO criteria; or individuals ≤ 70 years of age with previously untreated AML who refuse or are unable to receive chemotherapy with 7+3 as determined by the treating physician
Group C: Individuals ≥ 18 years of age with relapsed/refractory AML by WHO criteria; or with relapsed/refractory AML with mixed-lineage leukemia (MLL); or with previously untreated AML by WHO criteria and who would have met disease eligibility criteria for Group A or B but refuse or are unable to receive chemotherapy and hypomethylating agent as determined by the treating physician
Key Exclusion Criteria:
Known active central nervous system or leptomeningeal lymphoma
Subjects with acute promyelocytic leukemia (M3)
Treatment with proton pump inhibitors (PPIs) within 7 days prior to enrollment.
NOTE: Other protocol defined Inclusion/ Exclusion criteria may apply.
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There are 2 Locations for this study
Los Angeles California, , United States
Chicago Illinois, , United States
Maywood Illinois, , United States
Indianapolis Indiana, , United States
Fairway Kansas, , United States
Boston Massachusetts, , United States
Detroit Michigan, , United States
Detroit Michigan, , United States
New York New York, , United States
Durham North Carolina, , United States
Cleveland Ohio, , United States
Columbus Ohio, , United States
Portland Oregon, 97239, United States
Greenville South Carolina, , United States
Toronto Ontario, , Canada
Montreal Quebec, , Canada
Frankfurt , 60590, Germany
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