A Phase II Study of MBG453 plus Azacitidine and Venetoclax in People with Acute Myeloid Leukemia Who Cannot Have Chemotherapy

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A Phase II Multi-Center, Single Arm, Safety and Efficacy Study of MBG453 in Combination with Azacitidine and Venetoclax for the Treatment of Acute Myeloid Leukemia (AML) in Adult Patients Unfit for Chemotherapy

Purpose

The purpose of this study is to assess the safety and effectiveness of combining the investigational drug MBG453 with the anticancer drugs azacitidine and venetoclax in people with acute myeloid leukemia (AML) who cannot receive intensive chemotherapy. By blocking a protein called TIM-3, MBG453 may help immune cells called T cells attack and destroy cancer cells.

Azacitidine and venetoclax are standard therapies for AML; their use in combination with MBG453 is considered investigational. MBG453 and azacitidine are given intravenously (by vein) and venetoclax is taken orally (by mouth).

Eligibility

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

  • Patients must be newly diagnosed with untreated AML and not be able to receive chemotherapy due to older age (75 or older) or to other health problems.
  • In addition to patients with good physical function, this study is also open to those who are capable of only limited self-care and are confined to bed or chair for more than half of their normal waking hours.
  • This study is for patients age 18 and older.

For more information about this study and to inquire about eligibility, please contact Dr. Eytan Stein at 212-639-3314.

Protocol

20-200

Phase

II

Disease Status

Newly Diagnosed

Investigator

Co-Investigators