Spots Global Cancer Trial Database for Azacitidine or Decitabine With Venetoclax for Acute Myeloid Leukemia With Prior Hypomethylating Agent Failure
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Trial Identification
Brief Title: Azacitidine or Decitabine With Venetoclax for Acute Myeloid Leukemia With Prior Hypomethylating Agent Failure
Official Title: Phase II Study of Venetoclax With Alternative Hypomethylating Agent for Patients With Acute Myeloid Leukemia With Prior Hypomethylating Agent Failure: A University of California Hematologic Malignancies Consortium Protocol
Study ID: NCT04905810
Study Description
Brief Summary: This phase II trial evaluates the effect of azacitidine or decitabine and venetoclax in treating patients with acute myeloid leukemia that has not been treated before (treatment naive) or has come back (relapsed). Chemotherapy drugs, such as azacitidine, decitabine, and venetoclax, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading.
Detailed Description: PRIMARY OBJECTIVE: I. To evaluate the efficacy of venetoclax plus alternative hypomethylating agent (HMA), as defined by the primary endpoint of overall response rate, for patients with treatment naive acute myeloid leukemia (AML) eligible for venetoclax plus HMA with prior HMA failure. SECONDARY OBJECTIVES: I. To further examine the efficacy of venetoclax plus alternative HMA for patients with treatment naive AML eligible for venetoclax plus HMA with prior HMA failure using additional efficacy endpoints. II. To further evaluate the safety of venetoclax plus alternative HMA for patients with treatment naive AML eligible for venetoclax plus HMA with prior HMA failure.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
UCSF-Fresno, Clovis, California, United States
UCLA / Jonsson Comprehensive Cancer Center, Los Angeles, California, United States
University of California Davis Comprehensive Cancer Center, Sacramento, California, United States
University of Oklahoma Health Sciences Center, Oklahoma City, Oklahoma, United States
Contact Details
Name: Brian A Jonas
Affiliation: University of California, Davis
Role: PRINCIPAL_INVESTIGATOR
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