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Entospletinib Monotherapy and in Combination With Chemotherapy in Adults With Acute Myeloid Leukemia (AML)
Trial Status: administratively complete
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).
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.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT02343939.
