A Randomized, Open Label Phase 3 Study Evaluating Safety and Efficacy of Venetoclax in combination with Azacitidine after allogeneic Stem Cell Transplantation in Subjects with Acute Myeloid Leukemia (AML) (VIALE-T)
Study of Venetoclax and Azacitidine After Allogeneic Stem Cell Transplantation in Patients with Acute Myeloid Leukemia (AML)
Sponsor: AbbVie
Enrolling: Male and Female Patients
IRB Number: AAAU0573
U.S. Govt. ID: NCT04161885
Contact: Research Nurse Navigator: 212-342-5162 / cancerclinicaltrials@cumc.columbia.edu
Additional Study Information: The purpose of this study is to evaluate the safety and efficacy of venetoclax and azacitidine compared to Best Supportive Care in patients with Acute Myeloid Leukemia (AML) after an allogeneic stem cell transplant (SCT). This is the first randomized study comparing venetoclax in combination with azacitidine versus best supportive care in subjects with AML who have just received an allogeneic stem cell transplant. Randomization is a process in which the computer makes a decision based upon chance that decides which study treatment you will be assigned. Best supportive care includes a few different medications that are typically given after receiving a stem cell transplant. Venetoclax in combination with azacitidine may produce the same results as best supportive care, it may work better than best supportive care, or may not work as well as best supportive care. Venetoclax has been approved by the United States Food and Drug Administration (FDA) to treat specific medical conditions but is currently not approved to treat AML after undergoing SCT. Therefore, the use of venetoclax is experimental for the purposes of this study. Azacitidine is FDA approved for the treatment of Myelodysplastic syndromes but is currently not approved to treat AML when combined with venetoclax.
This study is closed
Ran Reshef, MD
Do You Qualify?
Are you at least 18 years old? Yes No
Have you been diagnosed with Acute Myeloid Leukemia (AML)? Yes No
Are you planning for allogeneic stem cell transplant or have received allogeneic stem cell transplant within the past 30 days? Yes No
You may be eligible for this study

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