HDM201, MBG453 and venetoclax in Acute Myeloid Leukemia or high risk Myelodysplastic Syndrome - Clinical Trial

What is the Purpose of this Study?

We are doing this study to learn more about how the study drug combinations (HDM201+MBG452 and HDM201+venetoclax) effect people with AML and MDS.

What is the Condition Being Studied?

R/R Acute Myeloid Leukemia (AML) and Myelodysplastic Syndrome (MDS)

Who Can Participate in the Study?

Adults who have:
-Relapsed/Refactory AML after having more than 1 prior therapy but less than 3 who have relapsed
-No acute promyelocytic leukemia with PML-RARA.
-No stem cell transplant within last 6 months and/or active GvHD requiring systemic immunosuppressive therapy.
-No active, known or suspected autoimmune disease

Age Group

What is Involved?

If you choose to join this study you will:
- Complete your standard of care (including blood tests, physical exams, etc.)
- Be given a small dose of the study drug (HDM201+MBG452 and HDM201+venetoclax)
- Be given increased amounts of the study drug until the known recommended dose is found
- Have a bone marrow aspirate or biopsy (small sample of tissue removed) at the time of joining

Study Details

Full Title
Novartis HDM201, MBG453: A phase lb, multi-arm, open-label, study of HDM201 in combination with MBG453 or venetoclax in adult subjects with acute myeloid leukemia (AML) or high risk myelodysplastic syndrome (MDS)
Principal Investigator
Hematologic Oncologist
Protocol Number
IRB: PRO00102354
NCT: NCT03940352
Phase I
Enrollment Status
Open for Enrollment
Contact the Duke Recruitment Innovation Center