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).

View Eligibility Criteria

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.

Study is for people with:

Acute Myeloid Leukemia

Phase:

Phase 1

Estimated Enrollment:

148

Study ID:

NCT02343939

Recruitment Status:

Terminated

Sponsor:

Gilead Sciences

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There are 2 Locations for this study

See Locations Near You

UCLA
Los Angeles California, , United States
University of Chicago
Chicago Illinois, , United States
Loyola University Medical Center
Maywood Illinois, , United States
Indiana University
Indianapolis Indiana, , United States
University of Kansas Medical Center Research Institute, Inc
Fairway Kansas, , United States
Dana Farber Cancer Institute
Boston Massachusetts, , United States
Henry Ford Health System
Detroit Michigan, , United States
Karmanos Cancer Institute
Detroit Michigan, , United States
Weill Cornell Medical College - New York - Presbyterian Hospital
New York New York, , United States
Duke Cancer Center
Durham North Carolina, , United States
University Hospitals Case Medical Center
Cleveland Ohio, , United States
Ohio State University
Columbus Ohio, , United States
Oregon Health & Science University
Portland Oregon, 97239, United States
Saint Francis Cancer Center
Greenville South Carolina, , United States
Princess Margaret
Toronto Ontario, , Canada
Jewish General Hospital
Montreal Quebec, , Canada
Universitätsklinikum Frankfurt Medizinische Klinik II
Frankfurt , 60590, Germany

How clear is this clinincal trial information?

Study is for people with:

Acute Myeloid Leukemia

Phase:

Phase 1

Estimated Enrollment:

148

Study ID:

NCT02343939

Recruitment Status:

Terminated

Sponsor:


Gilead Sciences

How clear is this clinincal trial information?

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