Entospletinib Monotherapy and in Combination With Chemotherapy in Adults With Acute Myeloid Leukemia (AML)
Status: | Terminated |
---|---|
Conditions: | Blood Cancer, Blood Cancer, Hematology |
Therapuetic Areas: | Hematology, Oncology |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 3/14/2019 |
Start Date: | July 1, 2015 |
End Date: | February 21, 2019 |
A Phase 1b/2 Study of Entospletinib (GS-9973) Monotherapy and in Combination With Chemotherapy in Patients With Acute Myeloid Leukemia (AML)
This study will evaluate the efficacy, safety, and tolerability of entospletinib (GS-9973)
when administered as monotherapy or in combination with chemotherapy in adults with acute
myeloid leukemia (AML).
when administered as monotherapy or in combination with chemotherapy in adults with acute
myeloid leukemia (AML).
Key Inclusion Criteria:
- Adults with AML in need of treatment
- Group A : Individuals > 18 years of age with previously untreated AML 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 or individuals <
70 years of age with previously untreated AML who refuse or are unable to receive
cytarabine as determined by the treating physician
- Group C: Cohort C1A: Subjects age ≥ 18 years with relapsed/refractory AML by WHO
criteria; Cohort C2: Subjects age ≥ 18 years with relapsed/refractory AML with MLL;
Cohort C3: Subjects 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.
We found this trial at
15
sites
University of Chicago One of the world's premier academic and research institutions, the University of...
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Indiana University INDIANA UNIVERSITY is a major multi-campus public research institution, grounded in the liberal...
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3181 Southwest Sam Jackson Park Road
Portland, Oregon 97239
Portland, Oregon 97239
503 494-8311
Oregon Health and Science University In 1887, the inaugural class of the University of Oregon...
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Dana-Farber Cancer Institute Since it’s founding in 1947, Dana-Farber has been committed to providing adults...
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Ohio State University The Ohio State University’s main Columbus campus is one of America’s largest...
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UCLA UCLA's primary purpose as a public research university is the creation, dissemination, preservation and...
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Loyola University Medical Center Loyola University Health System is committed to excellence in patient care...
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